Higher risk of infection, changes to treatment makes COVID-19 a double threat for cancer patients – theday.com

The coronavirus pandemic has caused significant changes and delays to treatment plans for many people battling cancer, who are more susceptible to the virus due to weakened immune systems, nationwide statistics show.

A survey conducted by The American Cancer Society Cancer Action Network in late March and early April found that half of more than 1,000 patients and survivors surveyed had seen their treatment interrupted in some way. Many are working with health care providers to alter their treatment plans skipping treatments, delaying therapies and surgeries, changing dosages and switching to virtual visits to lower their risk of exposure to the virus.

Thesurvey asked respondents about their experience accessing health care as a result of the pandemic, including the availability of appointments and services, and concerns about being able to safely get their treatments in the future. It found that27% of patients in active treatment said they have had their treatment delayed. Of those, 13% saidthey haveno clear timeline for whentreatment will resume.

Additionally, many cancer patients also have had their support systems ripped away, as they practice social isolation and see annual support events such as Relay for Life in southeastern Connecticut canceled.

Balancing risks

Approximately 20,300 people in Connecticut will be diagnosed with cancer in 2020 and 6,390 will die from the disease, according to Bryte Johnson, Connecticut Government Relations Director for American Cancer.

Andy Salner, medical director for the Hartford HealthCare Cancer Institute at Hartford Hospital, said cancer patients often have weakened immune systems, so may more easily contract the virus than someone without cancer. They alsomay developa more severe case ofthe COVID-19, the disease caused by the virus,and have a harder time fighting it.

Some cancers themselves, like multiple melanomas and most types of Leukemia, impact the immune system directly by altering blood cells. People with cancer might also be poorly nourished because cancer itself can make it hard to digest food, cancer cells can use up nutrients and cancer treatments like radiation therapy and chemotherapy can cause nausea and lack of appetite, according to the Cancer Action Network.

Radiation therapy, immunotherapy and chemotherapy also can lead to short-term immune system damage, and bone marrow or stem cell transplants that use high-dose treatments to kill cancer also may harm immune system cells for weeks to months, according to the American Cancer Society. Chemotherapy is the most common cause of a weakened immune system, because it causes a decrease in white blood cells, meaning a person's body won't be able to fight off infections as effectively.

At the Hartford Healthcare Cancer Institute in Waterford, oncologists Michael Kane and Sapna Khubchandani complete thousands of patient visits each year, and are helping patients design new treatment plansto battle and monitor their cancer while reducing their risk of exposure to the coronavirus.

For one local woman, a COVID-19 diagnosis meant missing her final session of chemotherapy, Khubchandani said. She did not identify the patient for privacy reasons.

Khubchandani said she didnt think missing one session so late in the treatment plan would have too much of an impact on the patient, but it wasnt ideal. An elective surgery related to the woman's cancer treatment, meant to take place after she completed chemotherapy, was delayed due to the virus, Khubchandani said.

COVID-19 has caused doctors to delay many suchnonemergency surgeries related to cancer treatment, including breast biopsies, lumpectomies or colonoscopies. Khubchandani, Kane and Salner all said they have had to make changes to surgery plans, either for patient safety or due to a lack of beds in intensive care units that are overwhelmed with patients battling the virus.

Doctors have been exploring alternatives, such as putting patients on hormonal treatment as they await surgery, so that were still treating the cancer while we wait, which will buy them time, Khubchandani said.

From some of his patients, Kane has made adjustments to medication dosages or administration intervals, to limit visits. Its all about individualizing treatment for each patients scenario, he said.

Worrying about the unknown

For one of Kane's patients, Richard van Etten ofHadlyme, protecting the 89-year-old from COVID-19 meant forgoing the transfusion he normally receives every three weeks.

Van Etten has been battling cancer since 2018, first in his bladder, then a cancerous module in his left lung, then in his lymph nodes.

Hecompleted chemotherapy and recently started a new drug called Keytruda, administered via infusions through a port for the cancer in his bladder and lymph nodes.

He recently learned that the cancer in his lymph nodes is gone, but his care team decided to continue his transfusions in case there were any residual cancer cells left, he said. But whenthe coronavirusbecame a concern, they decided to stop.

The virus hit and I was very hesitant about continuing my infusions, which were taking place in Waterford, he said. I talked with Dr. Kane and we decided to forgo them for now.

Since the start of the pandemic, he has been to the treatment center only once, to have his port cleaned. He said he is being very careful and is barely leaving his home, where he lives with his wife and daughter.

Van Etten said that he is absolutely anxious about contracting COVID-19, mostly due to his age. He said he feels confident about his decision to delay his treatment to limit his exposure to the virus but is worried about what might be happening inside his body.

Knowing that I was either in remission or close to it when I stopped, that it was at least temporarily under control, makes me feel OK with missing my infusions, he said. But that doesnt mean that in the back of my mind I dont wonder if it might be coming back.

Heis anxiously awaiting his next in-person visit, a PET scan scheduled for June 1, thats going to tell me whether any of the cancer has come back or not, he said.

Margie Elkins is a breast cancer survivor and active volunteer for the American Cancer Society and several other cancer organizations in southeastern Connecticut. While she is missing regular checkups and experiencing some delays in her own follow-up care, she said, One of the things that really worries me is not only the people who are experiencing delays in treatment but the people who have yet to be diagnosed, because the longer you wait in some cases, the larger the cancer becomes."

For thosewhose treatment hasbeen delayed, Its like their life is on hold because they dont know if their cancer is getting worse or getting better, she said.

Salner said delaying treatments certainly poses a risk. I think the worry would be that the cancer cells could potentially grow during that time (that treatments are delayed), that the treatment might be less effective if its delayed too far, he said.

Among survey respondents whose care had been canceled, delayed or changed by the pandemic, the most commonly impacted services were imaging procedures to monitor growth of cancer, supportive services such as therapy and in-person provider visits.

Salner said that decisions to delay chemotherapies and radiation, or reversing the order of treatments to prevent weakening of the immune system during the pandemic, were being made regularly and in partnership with patients and their families.

We want to balance making sure that we deliver the best cancer therapy possible but also place the patient at the lowest risk for getting what could be a life-threatening infection, he said.

In Waterford, Kane and Khubchandani have started screening patients for COVID-19 before starting them on chemotherapy or immunotherapy to ensure they are strong and healthy enough for the treatment. If a patient does have the virus, the doctors are delaying chemotherapy or immunotherapy in almost all cases. The ultimate decision though, is primarily left up to the patient. If they want to receive treatment, they likely will be able to, doctors agree.

Kane and Khubchandani also are implementing general precautions for people entering their offices: taking patients temperature, calling patients the day before to screen for COVID-19 symptoms and opting for virtual visits when possible. At the Waterford treatment center, theyve reduced the number of chairs in the waiting room and are scheduling laboratory services further apart. All doctors and patients are wearing masks at all times.

The extra precautions seem to be helping, Salner said. The Hartford Healthcare group has not seen a large influx of cancer patients testing positive for COVID-19.

Finding support

Some survivors are concerned about the emotional impact of COVID-19 on people currently battling cancer, worrying that they may feel overwhelmed and alone, both in their diagnosis and by social distancing.

Elkins said that she felt isolated when she was first diagnosed with stage1 breast cancer years ago, and can only imagine how that feeling is being compounded by the isolation of quarantine.

Greg Schlough, event chairman for the American Cancer Society Relay for Life of Southeastern CT, said that in his experience, cancer is a disease that causes people to really rally around you. The survivor saidthose with cancer tend to rely on their family and friends for support, like he did after being diagnosed with stage 3 melanoma on his 40th birthday in September 2000.

At the beginning, you get that doom and gloom feeling but when people start to come around and you start to see other people who have survived, you are able to say Hey, Im going to beat this thing. You know that you have people backing up and cheering you on, he said.

Right now, folks fighting cancer, especially a new diagnosis, may be struggling to find that support as they practice social distancing from their family and friends.

Schlough, in remission for 20 years, said that if he was a cancer patient right now, he would be afraid to go outside, and cant imagine how new patients are feeling.

For patients who are struggling with feelings of isolation or fear, events like the annual relay provide an opportunity to connect with others who are fighting the same fight, or who are examples of strength and survival. This years relay, which was set to be held on July 14 in Norwich, has been postponed indefinitely.

The annual fundraiser normally raises an average of $80,000 to $120,000 a year for the American Cancer Society, helping the society fund resources and support services to help people with cancer.

Schlough said organizers are hoping to reschedule the event for the end of summer, but it wouldfunction in accordance with social distancing guidelines and everyone will be required to wear masks. People currently in treatment, he said, may have to miss out or participate virtually.

Wed rather see them there next year smiling than this year with the risk of getting sick, he said.

Schloughsuggests patients or survivors who are emotionally strugglingor needhelp understanding treatment options shouldreach out to friends and family for over-the-phone support or call the American Cancer Societys hotline, 1 (800) 227-2345.

t.hartz@theday.com

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Higher risk of infection, changes to treatment makes COVID-19 a double threat for cancer patients - theday.com

The Latest Technological Innovations in Orthopedic Surgery 2020 Technology – IMC Grupo

Technology across the world is improving and innovatingwith time. Over the years, man-managed labor has almost finished from themarket and more and more technological and scientific gadgets are taking placemaking human labor more effective, efficient, and precise.

Medical science has also taken a lot of advantage fromthis scientific advancement therefore, we can say that doctors are making fulluse of science and technology and the world of medicine has evolved quiterapidly.

Orthopedic hospitalshave also seena remarkable transformation over time and the days when a regular orthopedicclinic only comprised of a few tools and a bad. The launch of innovativetechnologies, biologics, and hybrid items into the orthopedic industry isincreasingly growing.

Any of these emerging inventions gain regulatory approvalby showing significant equivalence to the US System of the Food and DrugAdministration (FDA) 510(k).

Surgeons play a key role in the implementation ofemerging technology to patients and will play a leading role in supportinghealthy, efficient, adequate, and cost-effective treatment, particularly forsurgical procedures. Surgeons will track and record the health results andadverse effects of their patients utilizing modern technologies and ensure thatthe new technology works as expected.

Ortho-biologics utilizes the regenerative ability ofcells in the human body. Ortho-biologics are created from compounds naturallypresent in the body which are used to facilitate the recovery of fracturedbones which injured joints, ligaments, and tendons.

These involve bone graft, growth factors, stem cells,platelet-infused plasma, autologous blood, and autologous controlled serum. Themesenchymal stem cells (MSCs) contained in the bone marrow has been shown to besuccessful in the production of the appropriate tissues.

Result in Orthopedic Procedures

Recent advances in this area, including growth factor andstem cell therapies, may contribute to faster recovery. One breakthrough isdrug-free bone grafts, which may be used to cure conditions such as orthopedicsurgery. Clinical trials have demonstrated that growth factors can improve thehealing cycle.

Stem cells will continually self-regenerate and transforminto either form of cell, providing an unmatched source of regenerativemedicine technology. Definitions of musculoskeletal procedures utilizing stemcells are listed below.

Biotechnology firms began utilizing orthopedic stemcells. For starters, BioTime works on stem cell therapies for age-relateddegenerative diseases, IntelliCell BioSciences on adipose-derived stem cellsfor orthopedic conditions, and Bio-Tissues on Ortho-biological treatments forcartilage defects.

Orthopedic procedures using robots are less intrusive anddeliver reproducible accuracy, resulting in shorter hospital stays and quickerrecovery times. The Swiss clinic, La Source, recorded a decline in averagehospitalization from 10 to 6 days with the usage of surgical robots.Nevertheless, this technology is also costly to develop, so solid,evidence-based trials are required to prove that robotic technology contributesto improved outcomes.

The Da Vinci Surgical Method became the first U.S. Food andDrug Administration (FDA)-an authorized robotic surgery program in 2000. Morebusinesses are investing in this technology to enhance navigation duringservice or to receive 3-D scans that aid in the design of custom joints.

Organizations that are interested, in robotics areinclined towards the following technological masterpieces:

Several modern surgical techniques are enhancing theresults. These involve motion-preservation methods, minimally intrusive surgery,tissue-guided surgery, and cement-free joint repair.

Motion recovery strategies require partial or completedisk removal and the usage of active stability systems and interspinous spacersthat do not impair versatility.

Minimally intrusive procedures involve the use ofendoscopes, tubular retractors, and computer-aided guidance devices, allowingan incision of just 2 cm instead of 12 cm in conventional therapies. Minimallyinvasive treatments are gaining popularity in joint and hip replacement and spinalsurgery.

Smart devices provide built-in sensors to offer real-timetracking and post-operative evaluation details to surgeons for better patientsafety across the clinical process. Such implants have the ability to minimizeperiprosthetic infection, which is an increasing orthopedic issue.Sensor-enabled innovations also presented health care professionals with arange of innovative, cost-effective goods.

Companies working in this field include:

3-D orthopedic printing is gaining traction in themanufacture of personalized braces, surgical equipment, and orthotics from arange of materials. 3-D printing technology cuts operating times, saves energy,increases the long-term reliability of the implant, and enhances the healtheffects of surgical procedures. 3-D printing technologies of orthopedics areinclusive of:

Companies investing in 3-D Orthopedic Printing

Medical science has taken a huge turn with the introduction of technology. The orthopedic industry has also transformed to a huge extent making sure that the specialists and surgeons are able to treat and operate on their patients without any hassle. Almost all the orthopedic hospitals are equipped with high-end gadgets and tools to assist the doctor.

Even though the technology has evolved greatly since thefield of medicine was invented, it is important to understand that this is justa beginning and there are many more things to come in the future.

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Nancy Davidson describes plans for reopening the Seattle Cancer Care Alliance as COVID-19 wave recedes – The Cancer Letter

publication date: May. 15, 2020

Nancy E. Davidson, MD

President and executive director, Seattle Cancer Care Alliance

Senior vice president, director and member, Clinical Research Division, Fred Hutchinson Cancer Research Center

Raisbeck Endowed Chair for Collaborative Research, Fred Hutch

Professor and head of medical oncology, University of Washington

This story is part of The Cancer Letters ongoing coverage of COVID-19s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is availablehere.

Nancy Davidson is now in the eleventh week of managing the COVID-19 pandemicthe longest stretch experienced by any health executive in the U.S.

And now, like her peers throughout the country, Davidson, president and executive director of the Seattle Cancer Care Alliance, is in the midst of ramping up plans for a comeback of cancer services.

The Cancer Letter asked Davidson to discuss these plans and share her thoughts on the way cancer care will evolve both at SCCA and nationwide.

This conversation is part of an informal series of stories, interviews, and commentaries that track cancer institutions as they seek to reopen, reorganize, and reinvent in the wake of the COVID-19 pandemic:

Health systems and academic cancer centers are cutting expenses to make up for operational shortfalls resulting from the pandemiclaying off employees, furloughing staff, and cutting salaries and benefits (The Cancer Letter, May 8, 2020).

Community oncology practices are experiencing a significant decrease in patient volume, as weekly visits dropped by nearly 40%, while cancellations and no-shows have nearly doubled (The Cancer Letter, May 1, 2020).

Washington was the first state to record what at the time was believed to be the first COVID-19 caseon Jan. 15, in a traveler from Wuhan, China.

Washington was also the first to register what appeared to be the first COVID-19 death, and SCCA as well as Fred Hutchinson Cancer Center, a component of the alliance, were the first major cancer institutions to take decisive action and shut down non-essential operations (The Cancer Letter, March 13, 2020).

At this writing, the state of Washington has 18,964 confirmed cases and 991 COVID-related deaths. The disease peaked weeks ago, and the spread has slowed. On May 15, for example, 101 new cases and 5 deaths were reported in the state. Washington ranks 18th in the number of cases.

Now, SCCA is among the first to make plans to reopen its operations.

We are bringing our stem cell transplant and our CAR T programs back online in a very thoughtful way, and theres a lot of pent-up demand for that. We had over a hundred transplant patients whove been waiting in the queue, for example. And so, were beginning to recall them and bring them in, Davidson said to The Cancer Letter.

We looked at things like imaging, close to a thousand mammograms that didnt take place because screening mammograms were paused during this time of maximum separation. And so, were also beginning to think about how we can thoughtfully recall those patients. Some patients who had more elective therapies also put it off for a while.

And so, we have a pretty good idea of what the numbers are. I mean, youre right. We are actively reaching out to patients and letting them know that the system was always safe. But were now at a position where we think that they can safely come for their in-person care.

And I think thatll be an important thing going forward, especially in cancer. You and I know that cancer didnt take a pause during the COVID pandemic, and it isnt taking a pause in the near future. We really need to be in a position where we can try to optimize our care going forward. We do know that some of our patients are worried. Theyre concerned about the possibility that they would somehow increase their exposure by coming in to their visits. And so, we have very, very robust testing in place in Washington. Thats also helped us.

Davidson spoke with Paul Goldberg, editor and publisher of The Cancer Letter.

Paul Goldberg:

You have more experience with more phases of COVID-19 than anyone else in the U.S. So, going back to the beginning, to what feels like a decade ago, you moved very, very fast and set up prioritization, and closed things down. What was it like to be on the inside of those decisions?

Nancy Davidson:

Paul, youre right that were in the 10th week of our pandemic response at the Seattle Cancer Care Alliance. As you point out, we are the first of the United States NCI-designated comprehensive cancer centers to experience this in a meaningful way. And at the time, I think that we knew that we were entering into uncharted territory, but territory that we were well equipped to deal with.

As you point out, were in a state that has had a very robust response.

We work at an institution that has a lot of people who are already involved in research in viruses. Fred Hutch houses one of the big coordinating centers for the HIV vaccine efforts, so that we felt that we were in a good position to do this, but we were kind of learning on the job.

Oncologists, though, are very good at dynamic situations, and tackling risk; right? Thats what we do for a living.

PG:

Well, you have also seen more impact on your institution and research, both clinical and basic. How would you summarize this impact?

ND:

We have seen much more impact than all of us would like on our cancer research.

Obviously, our COVID research is flourishing right now, but on the cancer side, we made the decision institutionally, across Fred Hutch and Seattle Cancer Care Alliance, to really slow down our basic laboratory research in accordance with the state guidelines and with our own modeling about what we should do to try to flatten the curve.

And we also made the decision to really limit access to some of our clinical trials, particularly the phase I clinical trials, where we felt that the real goal of a phase I trial is toxicity rather than improving patient wellbeing. And we also closed some of our phase III clinical trials, because we felt that a standard treatment option was available for those patients.

But Paul, weve continued our phase II clinical trials all during this time, for patients where we thought that clinical trial participation would be important for their wellbeing, and we certainly have continued care on trial for everybody who was already on trial. The new accrual was limited more to folks who were going on to the phase II trials.

And were now doing the reverse.

Were at a point where were able now to think about how to wind up after the wind-down. And so, right now, we are, in a very thoughtful and deliberate fashion, opening about 10% new trials and 10% of our closed trials over the next week or so.

Well look carefully at the impact of that, and then we hope to continue that ramp up in a stepwise fashion. And weve tried to prioritize those for trials that are in patients best interests, trials that really reflect some of our primary research interests as an institution, and those where we think that we can try to optimize the safety of the participants and our staff.

PG:

Do you think anything has been irrevocably lost, in terms of data?

ND:

I think that in some of our clinical trials, we werent able to collect every single piece of data that mightve been mandated by the clinical trial.

Certainly, we were able to collect all the data that would be vital for patient safety. And we may not be able to get all of those things, but I suspect that for the clinical trials that have remained in operation and those that will be restarting, that well be able to gather the information that we need to address the primary aims of the clinical trial.

PG:

Ive heard it said that with randomization, problems affect both sides of the trial. So, with randomized trials, you might actually be in okay shape.

ND:

I think so. Many of the randomized trials are very large trials; right? And one would hope that what were going to see is a short period of a pause, and then, youre right, the trial will resume in its full form, and that we will not have any compromise of the primary outcome of the trial.

PG:

What about clinical care? Has that been set back?

ND:

No, I dont think so. I do think that oncologists are pretty good at dealing with adversity, as are our patients. So, we have remained operational the entire time. Weve actually used this as an opportunity to accelerate some of the initiatives that we probably should have done before.

All of us have become very adept at telehealth now, and we are hoping that well be able to right-size how we would use that going forward. And, of course, were hoping that the reimbursement strategies nationally will make that a viable alternative for some patients where its appropriate.

We continued all of our infusion therapies, by and large. The one place where we made some pretty strategic decisions was to slow access to our cell-based therapy trials and treatments, our CAR T trials and our stem cell transplant trials.

As members of a healthcare ecosystem, we needed to be in line with the priorities of the state of Washington and the Puget Sound region at the time, to make sure that we freed up inpatient beds and critical care resources for what we thought would be the surge of COVID-19 patients.

And so, that meant that those transplant and CAR T patients were the patients who were the most likely to require those things, and we made the decision to slow their entry into our system. Were now restarting that, too, Paul. As of last week, were reentering some of the most needy patients who require those particular kinds of interventions, because we feel that we have the hospital capacity to care for them should they become ill.

PG:

Have you had to do triage on COVID? On, say, ventilators?

ND:

Thankfully, we have not. I think, again, the state of Washington has been very forward-thinking on this. In our state, early on there were a lot of workplaces that put people to work from home. The Fred Hutch and the SCCA did this early on; the governor has been very diligent in the state of Washington.

And so, I think we were in happy circumstances where, thankfully, our critical care capacity was higher than our needs. And so there was never a time that Im aware of where in the University of Washington system we had to triage the use of ventilators.

PG:

What role have disparities played in this crisis?

ND:

Well, gosh, I think thats an area where were all trying to sort it through; right?

Our region has a large homeless population. Thats certainly a major form of disparity. And so, I think that within the region, were trying to work collectively with our government facilities and with our partner organizations to make sure that our homeless population has access to the kind of care that they need across the boardthings that are related to prevention or treatment in COVID, as well as underlying social and health problems that they might have.

Ours is a state that has a large Native American population, and so, were trying to make sure that we work pretty actively with our tribes, where appropriate, to make sure that theyre getting the appropriate health care.

And you may know that also in our region the Yakima Valley, which is in the middle of the state, is the home of our larger Hispanic population. That region has been particularly hard hit, and I think that might have to do with the nature of the workforce and the kinds of jobs.

These are folks who often work in situations where its hard to distance in the workplace, and they work in vital industries, and so, this is a population thats also been especially hard hit. So, were trying very hard to make sure that we understand these individuals who are at particular risk, and we do everything we can to try to mitigate that risk within those individuals.

PG:

How soon do you think you might have some data?

ND:

I dont have a good answer for you on that one right now. I think that everybody is pedaling as fast as they can, Paul, to try to get data generally. And then, also, for specific populations.

For example, populations of patients with cancer.

AACR had a session where they tried to review what we know about cancer as a risk factor for COVID, and it looks to me like we dont have a clear understanding of that as a field, either. So, there are a lot of places where we have knowledge that we really have to gain over relatively short period of time.

PG:

What about financial impact? Have you had to have furloughs or any other forms of belt-tightening?

ND:

We think our workforce is incredibly important. Thats obviously one of our most important resources, and so, wed like very much to retain our workforce as best as we can going forward. Weve been fortunate that many people were in a situation where they could work from home.

And so, many of our workforce members who dont have to be physically in the office or who are not directly patient-facing are working from home and theyre working extremely hard.

I think it will be interesting to see how it goes over time. What the healthcare workforce looks like generally is something that were all going to need to be thinking about as we go into the months and the years aheadwhat weve learned from this, and what we can use to try to optimize the delivery of healthcare going forward generally, and also the delivery of cancer care specifically.

PG:

People talk about a rebound in demand for carepatients showing up saying, Take care of us. You should probably be starting to see it about now, I would think. Is it happening?

ND:

We are hoping that were going to see that shortly, and, actually, were trying to begin to promote that, if you will.

First, I told you about the fact that we are bringing our stem cell transplant and our CAR T programs back online in a very thoughtful way, and theres a lot of pent-up demand for that. We had over a hundred transplant patients whove been waiting in the queue, for example. And so, were beginning to recall them and bring them in.

We looked at things like imaging, close to a thousand mammograms that didnt take place because screening mammograms were paused during this time of maximum separation. And so, were also beginning to think about how we can thoughtfully recall those patients. Some patients who had more elective therapies also put it off for a while. And so, we have a pretty good idea of what the numbers are. I mean, youre right. We are actively reaching out to patients and letting them know that the system was always safe. But were now at a position where we think that they can safely come for their in-person care.

And I think thatll be an important thing going forward, especially in cancer. You and I know that cancer didnt take a pause during the COVID pandemic, and it isnt taking a pause in the near future. We really need to be in a position where we can try to optimize our care going forward. We do know that some of our patients are worried. Theyre concerned about the possibility that they would somehow increase their exposure by coming in to their visits. And so, we have very, very robust testing in place in Washington. Thats also helped us.

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Nancy Davidson describes plans for reopening the Seattle Cancer Care Alliance as COVID-19 wave recedes - The Cancer Letter

The first breakthrough coronavirus antibody drug might finally be here – BGR

The moment we find COVID-19 treatments that are truly effective, well see the novel coronavirus with different eyes. Yes, the virus is highly transmissible and can lead to severe illness and death. But effective drugs that can block its ability to infect cells and meds that can reduce respiratory distress and inflammation will turn the new disease into an infection that well learn to live with.

Several experts warned this week that the novel coronavirus is here to stay, and we may never get rid of it even when the vaccines arrive. But an increasing number of reports detail various therapies that can be used to improve the odds of recovery. Some of them rely on drugs that were developed to treat other conditions. Others use stem cells. And then there are plasma transfusions from patients who survived COVID-19.

Researchers are also working on a new type of drug thats related to plasma therapy, antibody-based meds that can offer the same kind of protection as a plasma transfusion. Now, we have learned that one of the antibodies capable of blocking the SARS-CoV-2 virus from binding to cells has proven to be 100% effective in labs.

The novel coronavirus binds to human cells via a spike protein that can link up to ACE2 receptors. Then the virus enters the cell where it wreaks havoc. The cell deciphers the viruss genetic information to create more and more copies of the virus. The cell dies in the process, and the new replicas are released into the body where they are free to infect other cells and continue to replicate.

The immune system detects pathogens and can fight them very efficiently. Many people will get COVID-19 and never know it because theyll never even present any symptoms. That means the immune system cleared the virus before it could cause complications, and the resulting antibodies will be able to deal with the illness in the future, providing immunity against COVID-19 for an unknown period of time. Thats why plasma treatments work. Doctors use the antibodies from donors to treat other patients with weaker immune systems. But demand for plasma far exceeds supply, and thats why monoclonal antibody drugs would work better.

Sorrento is one of several companies working on this breakthrough type of drug. The pharmaceutical company has found what it describes as a potent anti-SARS-CoV-2 antibody that can completely prevent the virus from linking to ACE2 cells in lab tests. The antibody is called STI-1499, and Sorrento says its been able to deliver 100% inhibition of the virus in healthy cells after four days of incubation.

Sorrento has screened billions of antibodies in its proprietary G-MAB fully human antibody library and identified hundreds of candidates that can bind to the S1 subunit of the SARS-CoV-2 spike protein. A dozen of them have been able to block the interaction between S1 and ACE2.

STI-1499 stood out for its ability to completely block SARS-CoV-2 infection of healthy cells in the experiments. The company says that the virus was neutralized even in low antibody doses. This antibody will likely be the first antibody to be used in the COVI-SHIELD antibody cocktail that will include a combination of antibodies meant to deal with potential mutations of the coronavirus. STI-1499 is also expected to be used as a standalone therapy in a COVI-GUARD drug, assuming it receives regulatory approval.

Sorrento will request priority evaluation and accelerated review. Clinical trials will have to prove the antibody works just as well in patients as it does in lab conditions.

Assuming STI-1499 is effective and safe, Sorrento says itll be able to produce up to 200,000 doses per month, and the company plans to make 1 million of them while its waiting for FDA approval. Manufacturing capacity could be increased through partnerships to meet demand. If all goes well, STI-1499 might be among the first brand new drugs developed specifically to treat COVID-19.

Doctors analyzing lung CT scan. Image Source: STEPHANIE LECOCQ/EPA-EFE/Shutterstock

Chris Smith started writing about gadgets as a hobby, and before he knew it he was sharing his views on tech stuff with readers around the world. Whenever he's not writing about gadgets he miserably fails to stay away from them, although he desperately tries. But that's not necessarily a bad thing.

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The first breakthrough coronavirus antibody drug might finally be here - BGR

Coronavirus: The trials and triumphs of UAE residents – Gulf News

Trials and triumphs of the COVID-19 combat Image Credit: Gulf News

Dubai: The first case of coronavirus in the UAE was announced on January 29, 2020. Thats around three-and-a-half months ago. Time flies, you would ordinarily be inclined to think. But these are extraordinary times.

Ever since the beastly virus spread its ugly tentacles, everything weve been thinking, saying or doing has revolved around COVID-19. But beyond the general fatigue that were all beginning to feel, there is no denying that life as we know it why, even death has changed forever.

Gasping patients gone without a goodbye; family members watching funerals of loved ones on Facebook; infected couples having to leave young children in the care of others; tables turning on doctors and nurses COVIDs trying tales are heart-wrenching.

But the unimaginable trauma notwithstanding, there are those who are counting their blessings too, whether its a new mum beating the virus with her just-born; a patient coming off the ventilator after 20 days; or the UAEs health care community clocking record testing rates and its researchers achieving a treatment breakthrough.

A look at the trials, tribulations and triumphs of UAE residents since the COVID-19 combat began:

The ultimate trial

Its bad enough to lose a loved one, but not being able to bid goodbye takes away even the sense of closure.

THE WAY IT IS

Global protocols on heath safety, hygiene and social distancing stipulate that coronavirus patients must get treated in isolation, and even depart alone.

Global protocols on heath safety, hygiene and social distancing stipulate that coronavirus patients must get treated in isolation, and even depart alone, so one has no choice but to let go.

When Bangladeshi expat Tofail Alam, 51, passed away in Abu Dhabi last week, his wife Nausheen told Gulf News her husband went to see a doctor at a hospital in March because he had a bad cold.

Tofail Alam

But he was admitted the same day and transferred to a public hospital for treatment. We lost the pillar of our family to the coronavirus pandemic. It is so devastating that I simply have no words.

A friend who tried to contact Alam in hospital said, The calls never went through. So all I could do was ask the nurses about his condition. Somewhere along the line, he learnt that the father of two was no more.

Funeral on Facebook

Even in non-coronavirus cases, flight suspensions in recent times have meant that some residents havent been able to attend funerals of loved ones in other countries.

Among them: A Keralite family in the UAE who watched the funeral of their cancer-stricken son Jeuel G. Jomay, a Grade 10 student at a Sharjah school, on Facebook on April 16. They could not accompany his body when it was flown to native Kerala under lockdown.

Jeuels funeral ceremony back home began at 4am in the UAE. His cousin told Gulf News her family and Jeuels family watched the five-hour ceremony on Facebook while the St Marys Church in Sharjah provided a link to the YouTube livestreaming on its website for members here to watch the service.

None of the flights was getting sanctioned soon. Jeuels father wanted to fly with him. But that was not possible, the cousin told Gulf News at the time.

Similarly, on April 17, Dubai-based Pakistani expat Ghulam Mustafa Awan watched the funeral of his father Malik Nazir Ahmad on video. Ahmad had died of a heart and lung condition.

I tried everything, but I couldnt go and see the face of my father one last time, said Awan.

- Ghulam Mustafa Awan

In both cases, COVID-19-related restrictions prevented their travel.

Double whammy

Telling a young COVID-19 mother of three that her husband, also a coronavirus patient, has passed on can by no means be easy.

But that is precisely what Dr Samara Khatib, Consultant InternalMedicine and team lead at the COVID-19 ward at Mediclinic Parkview Hospital in Dubai, was tasked to do recently.

We had to take the help of mental health professionals to break the tragic news to the patient, who is in her 30s, said the American doctor of Syrian origin. It shook us as healthcare workers.

- Dr Samara Khatib

Coronavirus has struck other couples too in the UAE, which has meant they have had to leave their children in the care of others.

Dubai-based Suman Manning, who tested positive along with her triathlete husband Shane Manning, said her sister took care of her triplets during the ordeal. Although she showed no symptoms, she had to isolate herself and tell her kids and sister to keep away from her, while her husband was recovering in hospital.

It was a particularly trying time as the kids had just started the first week of remote learning and needed some kind of support, she told Gulf News earlier.

Were not invincible

Working on the frontlines in the face of an invisible and yet-to-be-conquered virus, doctors and nurses are probably at the highest risk of contracting COVID-19. Ask Reem Yousef, who works as an emergency nurse manager at the Emirates Specialty Hospital in Dubai.

- Reem Yousef

The Lebanese mum, who is still breastfeeding her nine-month-old baby, told Gulf News: It is really hard. I am literally wearing my heart on my sleeve for my little one, Relle. Yes, there is fear of contracting COVID-19 as we work 12-15 hours a day for five days. We try our best to manage. When I go back home, I take utmost care to completely sterilise myself before I hold my baby in my arms again.

Dr Khatib said she tests herself for the virus at least once a month. I am also very particular about hygiene. Its almost as if I suffer from obsessive compulsive disorder (OCD). There is no respite on the front line and when we see our own colleagues falling prey to the virus, we feel emotionally distraught. It makes us realise we are not invincible. But we have a responsibility to stay safe and healthy as we can pass on the virus to other patients or our families back home.

Despite the best efforts though, the tables do get turned sometimes. And when that happens, the resolve to combat coronavirus only gets stronger.

As a doctor duo at Zulekha Hospital Dubai, Dr Nishath Ahmed Liyakat and Dr Unni Nair, who have recovered from COVID-19 testify, there was no way the virus would have held them back from doing their duty once they had received the treatment and completed their quarantine.

Victor and the virus

Yes, the dismal health crisis surrounding us does have its share of good news. As the official tracker posts new cases every day, there are considerable recoveries too, with each corona warrior, irrespective of whether they are a mild or critical case, emerging as an emphatic victor against the virus.

Speak to patients who have turned the blind corner, and their words inspire you. While some will tell you coronavirus is not a death sentence, others will say they do not wish their hellish experience even on their worst enemies.

- Wilfredo

Either way, there is no bitterness and no taking away from the huge sense of relief and gratitude on the road to recovery.

I hardly had any symptoms and it never felt like a death sentence. But now that I have completed my quarantine, I thank God its over, said one young Indian woman who did not want to be named.

Wilfredo, a Filipino expat, who came out of the ventilator after 20 days at Al Zahra Hospital, Sharjah, said, I prayed hard to God and placed my trust in the medical team. Now, Im getting better every day and can only remember those weeks on the ventilator like it was yesterday.

In Abu Dhabi, Raneen Abu Zaher, a Palestinian homemaker, and her newborn son, Jad, who also beat coronavirus, inspire hope.

The duo were diagnosed with the infection when Jad was just a day old. But two weeks later, when they got the all-clear, the mother of three told Gulf News, I tried to hold on to my faith, and prayed for my entire family.

UAE will not let you down

If theres one thing any patient in the UAE will vouch for, its the fact that they could not have been in better hands. Whether it is Liu Yujia, a 73-year-old visitor from Wuhan, China, who was the first patient to have fully recovered in the UAE or Aubrey Escano, 27, a Filipina from Abu Dhabi who is currently under quarantine, there has been only praise and gratefulness for the UAE for the manner in which coronavirus cases are handled.

Escano in her message said, I would like to tell COVID-19 patients not to lose hope, not to worry and continue the fight because the UAE will not let them down.

The exemplary patient care apart, the UAE has also hit international headlines for carrying out a record number of laboratory tests for coronavirus. According to the Ministry of Health and Prevention, the UAE leads global coronavirus testing with 1.5 million tests conducted since the beginning of the outbreak. The UAE daily testing average equals a four-month average of COVID-19 testing in other countries.

- Aubrey Escano

Addressing a UAE Government remote meeting today, Minister of Health and Prevention Abdul Rahman Bin Mohammed Al Owais said, The UAEs response to the COVID-19 pandemic is unique and different from other countries. The UAE has shown exceptional management of the crisis, whilst leveraging other countries experiences. However, the level of response was different, given the demographic composition in the country, which is home to more than 200 nationalities, and its distinct resources, readiness and experiences in many sectors.

On May 1, doctors and researchers at the Abu Dhabi Stem Cell Centre also achieved a major breakthrough with a promising stem cell treatment for COVID-19 patients.

The Ministry of Economy even granted a patent for the development of the innovative method, which was administered to 73 COVID-19 patients, all of whom were cured of the virus using stem cells.

Researchers, who have completed the initial phase of clinical trials, are now working on demonstrating the efficacy of the treatment.

Now that is no mean achievement, by any measure.

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Daughter of former journalist who died of colon cancer battling cancer of the bones – Nairobi News

This Thursday will mark exactly 10 years since journalist Elly Abongo succumbed to colon cancer in Nairobi. He died just days after being featured in Daily Nations Living magazine, narrating his struggles with the disease.

His widow, Joyce Wambui, and daughter, Lakita Abongo, will be marking the anniversary in India. Since January, they have been at the Medanta Hospital in New Delhi where the 13-year-old Lakita is being treated for cancer of the bones.

CELL TRANSPLANT

Her right leg was amputated at the hip in March and she is now awaiting a stem cell transplant to as medics seek to ensure that the cancer, called osteosarcoma in technical terms, is banished from her body.

Hers is a hereditary condition. Tests by medics on Lakitas blood showed that she had inherited a syndrome that increases chances of a person contracting cancer.

She tested positive for Li-Fraumeni syndrome. That one makes someone be more susceptible to different types of cancer. So, that can run in the family, Ms Wambui told the Sunday Nation on Friday.

She explained that the death of Mr Abongos mother and two siblings might have been due to the predisposition to cancer, though it had not been established as such.

In Lakitas case, the cancer began with pain in the leg, which they tried managing but it just couldnt go away. Several scans later, it was discovered that she has osteosarcoma, which was manifesting itself as a tumour. The cancer forms in the cells that form bones.

LOSS OF LEG

One of the interventions done was to remove the affected part. In its place, a metallic blade was introduced to ensure the leg still supported the body.

But during the examination in January, it was discovered that the tumour was not responding to chemotherapy.

They did a scan and found out that the chemo wasnt working. When they analysed the site of the tumour, there was no other option but an amputation, said Ms Wambui.

To place further stops on the cancer, which doctors have deemed aggressive, medics have recommended a stem cell transplant. This weekend, doctors have been harvesting cells from her body to be reconditioned and later returned to her body.

If all goes according to plan, the transplant is scheduled for May 18. But that depends on whether they will have raised the Sh4.9 million required for the procedure, an amount that the family is asking well-wishers to contribute.

LOSS OF DADDY

If there is no money, they will continue with chemotherapy until we get money for a stem cell transplant, said Ms Wambui.

Lakita, Standard Eight pupil at Juja Preparatory, said it has not been easy dealing with the loss of a leg.

Sometimes I just feel like my leg is there, but its not. I reach out to touch it, but its not there, she said.

She hopes all financial hurdles will be cleared soon so that she can return to Kenya by June.

(I wish to) go back to my family and friends to resume school and sit my KCPE, she said.

Her father died at 32, when she was three years old. He had worked for Family TV, Citizen TV, Radio Ramogi, BBC Radio among other media outlets by the time of his demise.

Well-wishers can donate through M-PesaPaybill Number 8011987, with the senders name as the account name.

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Cancer treatment inspires new dad to raise 18k for NNUH with mass head shave – Eastern Daily Press

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PUBLISHED: 06:30 16 May 2020 | UPDATED: 08:30 16 May 2020

James Barham was diagnosed with aggresive leukaemia five weeks after the birth of his son. He has raised more than 18k for the NNUH while undergoing chem at the hospital. Picture: James Barham

James Barham

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On April 2 his first child, Charlie, was born at the Norfolk and Norwich University Hospital (NNUH).

Four weeks later, on Monday May 4, the builder from Drayton got out of bed and blacked out.

The 31-year old went to A&E that day for blood tests and the next day went back to the NNUH for a bone marrow biopsy.

Just 10 minutes after leaving the hospital, he had a call. Mr Barham had an aggressive blood cancer called acute myeloid leukaemia.

We were devastated, Mr Barham said. I was in absolute bits and just couldnt believe it.

Just four days before Charlie was born, Mr Barham said he started feeling nauseous but put it down to nerves ahead of the his sons birth.

It was a long birth and a bit traumatic, he said.

He then started feeling tired but thought it was the stress of having a new baby.

Last Wednesday, the day after he was diagnosed with leukaemia, he was back at the NNUH to start weeks of chemotherapy.

No visitors are allowed because of coronavirus, but staff on Mulbarton ward have moved him to a window bed so he can see his wife Katie and Charlie through the window.

But the new dad has not let the devastating news, or visiting restrictions, get him down.

He launched a charity head shave appeal on Facebook last week to raise funds for the hospitals cancer department and encouraged friends and family to join in.

I thought it would be an opportunity to give back, Mr Barham said.

Im going to be losing my hair anyway and everyone else is in lockdown and not had a haircut for weeks so I thought their friends and family could sponsor them for a head shave too.

Mr Barham lost his locks on Wednesday and has been joined by around 50 other head shavers.

In just over a week he has smashed his target of 6,000.

More than 18,000 has now been donated to the NNUHs charity from 800 people across the world through the Just Giving website. They have had donations from the US, Italy as well as his wifes native Australia.

I wouldve been over the moon if we had raised 2,000, he said. I have got messages from people in the US and India just giving their support.

All donations will go to the NNUHs cancer department, with staff deciding how best they can use it, he said.

The ex-Taverham High School pupil said doctors had told him the cancer was unlikely to be killed by chemotherapy, meaning he will need a stem cell transplant at Addenbrookes Hospital in Cambridge.

Im fit and healthy but this cancer comes up so rapidly and can kill someone. That is what has been the most surprising thing for me, he said.

On his Just Giving fundraising page, he wrote: I have a long journey ahead of me with leukaemia as my new temporary normal.

The constant care and attention Im receiving while Im in hospital is truly exceptional, all from men and women who are overworked and seriously underpaid.

Im now in their hands, so its the least I can do to try and help them back in a small way. Your support will be greatly appreciated. Lets all go forward and be kind to one another.

Louise Cook, head of fundraising at the NNUH, said: We are incredibly grateful for the support and fundraising James, his family and friends are undertaking at this difficult time.

We are overwhelmed at the support shown to the hospital charity, where the money raised will go to support our work with cancer patients. We wish to say thank you to everyone who has got behind James fundraising.

You can donate to Jamess headshave at http://www.justgiving.com/fundraising/james-barham3

A leukaemia which comes with little warning

The NHS says symptoms of acute myeloid leukaemia (AML) can come on suddenly.

They include feeling tired and weak, weight loss and breathlessness.

This blood cancer is caused by a DNA mutation in the stem cells in the bone marrow.

The NHS website says the mutation causes the stem cells to produce many more white blood cells than are needed.

The white blood cells produced are still immature, so they do not have the infection-fighting properties of fully developed white blood cells.

As the number of immature cells increases, the amount of healthy red blood cells decreases and causes the symptoms of leukaemia.

The NHS says it is not know what triggers the genetic mutation.

Patients are treated with chemotherapy or radiotherapy but if that does not work a bone marrow or stem cell transplant may be needed.

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Doubts cast on claims that ’19m Brits have had coronavirus’ – Yahoo Lifestyle

Scientists have questioned a study that suggested that 25% of the UK have already had coronavirus. (Picture: PA)

Scientists have cast doubt on suggestions that more than 19million Britons have already had coronavirus.

A study by researchers from The University of Manchester,Salford Royal and Res Consortium, suggested that 29% of the population - more than 19m people - may already have been infected with COVID-19 and recovered.

The study, published in the International Journal of Clinical Practice, claimed to be the first to use published local authority data to assess the cumulative impact of infection since the outbreak began.

But fellow scientists have voiced concerns over the methodology of the research and said it had not taken account of the level of uncertainty surrounding unreported cases.

Dr Konstantin Blyuss, Reader in Mathematics at the University of Sussex, said: There are several problems with this study.

The first involves the data used, Dr Blyuss said, which only covers the period up to April 23 and suggests that the peak happened on April 8 and numbers of new cases had been below 4,000 since then, when in fact they had exceeded 4,000 for most of April and the first week of May.

Live: Follow all the latest updates from the UK and around the world

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Another issue is that the study based its estimates on 73,000 reported cases, he said, while that number now stands at 233,000.

The second issue concerns the methodology, Dr Blyuss added.The value of R is notoriously difficult to estimate, and as a result, the estimates always have a wide margin of error, which means that it is almost impossible to rely on accurate estimates of R for any significant population-wide conclusions.

Dr Adam Kucharski, Associate Professor in Infectious Disease Epidemiology at the London School of Hygiene & Tropical Medicine, also cast doubt on the study, saying: In the absence of direct measurements, models can be useful for estimating the extent of infection from wider data sources.

Story continues

However, given how difficult it is to estimate the extent of unreported cases in a population from reported cases alone, it is likely that there is huge uncertainty in the estimates produced by the model used in this paper, and unfortunately this uncertainty is not reflected in the single value quoted in the paper and the press release.

In the study, the researchers claimed that published local authority data had enabled them to calculate the R-value - the number of people infected by one person with COVID-19 - within each local authority area.

Dr Adrian Heald, from The University of Manchester, said: COVID-19 is a highly infectious condition and very dangerous for a small group of people. However a much larger group seem to have low or no symptoms and have been unreported.

This study tries to provide an estimate of the number of historic infections and gives us all a glimmer of hope that there may be light at the end of the tunnel.

We show how effective social distancing and lockdown has been. Though this is a tragedy, it could have been far worse.

Mike Stedman from Res Consortium, who carried out the data analysis, added: The figures are not perfect, with the numbers of severely ill patients as a proportion of the total cases being used as a market for estimates of wider infection.

Only extensive antibody testing could give us a more accurate picture - but as that is only just becoming available, we believe this form of modelling is important in informing the best approach to unlocking the population.

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Michael Hiltzik: Don’t be taken in by stem cell firms offering unsubstantiated therapies for COVID-19 – Rome News-Tribune

If you think this can help you, Austin Wolff said earnestly into the camera, its worth a shot .It can only help.

Wolff was speaking on a YouTube video produced for the Novus Center, a Studio City business run by his mother, Stephanie, selling stem cell-related products said to treat chronic pain, sexual performance issues and the effects of aging.

In recent weeks, Novus has begun directing its pitch at potential customers fearful about the effects of the novel coronavirus, implying that its stem cell exosome vapor the supplies for which can be shipped overnight to customers homes can improve lung strength, the immune system and ward off viruses and disease. (Exosomes are a form of cellular secretion.)

These are opportunistic businesses, and COVID-19 for them is an opportunity.

Novus videos bristle with formal disclaimers. Its not going to cure anything, Austin Wolff says on one video. You should only do this if you want to try it.

But the videos seem aimed at viewers desperate for any possible defense against a pandemic whose implacable spread seem to grow more frightening with every passing day.

Novus charges $10,000 for the shipment of vials containing the exosomes and nebulizing equipment. Stephanie Wolff says the business, which has been open for four years, has served about a dozen customers worried about COVID-19 in the last month or two.

Promoters of untested and unlicensed stem cell treatments have jumped into the coronavirus market with both feet, says Leigh Turner, a bioethicist at the University of Minnesota who has been tracking the spread of clinics pitching these treatments to consumers for years.

The direct-to-consumer clinics have pivoted their marketing message to treating or preventing COVID-19, Turner told me. Thats not really shocking, in a way; these are opportunistic businesses, and COVID-19 for them is an opportunity.

In a paper scheduled to be published shortly in the prestigious journal Cell Stem Cell, Turner examines how these businesses are preying on public fears and anxieties about the pandemic.

Typically, their claims fall short of actually promising cures or even specific treatments; that holds at bay the Food and Drug Administration, which has sought to shut down clinics offering unproven therapies for conditions such as Alzheimers, diabetes, multiple sclerosis and erectile dysfunction.

Some use the language of immune booster or preventive intervention, Turner says. Theyre not trying to treat somebody whos in an ICU bed. Its more the worried well theyre going after people who are anxious, fearful of the pandemic, and susceptible to claims that a stem cell procedure will reduce their chance of becoming infected.

These treatments can come with a healthy price tag, ranging hundreds to thousands of dollars. But they run up against one indisputable fact: There are no approved stem cell treatments for COVID-19.

Those are the words of Martin F. Pera, a leading stem cell researcher who is editor-in-chief of Stem Cell Reports, the open-access journal of the International Society for Stem Cell Research. The society issued a stern warning March 6 against claims that stem cells can be used to treat people infected with COVID-19.

As for the products sold by Novus, the FDA warned consumers in December that there are currently no FDA-approved exosome products. The agency stated that certain clinics across the country offering such products to patients deceive patients with unsubstantiated claims about the potential for these products to prevent, treat or cure various diseases or conditions.

Weve reported for years on the proliferation of clinics selling purported therapies based on stem cell injections costing as much as $15,000 each.

These treatments arent supported by scientific research, typically arent covered by insurance, and have been targets of an FDA crackdown. (Turner did groundbreaking work with UC Davis biologist Paul Knoepfler in 2016, sounding the alarm about the spread of these clinics.)

In early April, the FDA sent letters to two stem cell firms, Dynamic Stem Cell Therapy of Henderson, Nev., and Kimera Labs of Miramar, Fla., that it said had been marketing their products for the treatment or prevention of COVID-19 and warning them that any such products would have to meet regulatory standards for drugs. But the agency didnt explicitly threaten them with legal consequences. Kimera is the supplier of exosomes to Novus.

Frightened laypersons arent the only targets of claims for cellular treatments for COVID-19. So are decision-makers and government regulators.

The FDA came under fire in March when it issued an emergency use authorization to allow the prescribing of two antimalarial drugs, chloroquine and hydroxychloroquine, for COVID-19 patients. The action came after President Trump had been relentlessly promoting the drugs as potential game changers in the battle against COVID-19.

Less than a month later, the FDA issued a warning against using the drugs against COVID-19 because of reports of serious heart problems in COVID-19 patients who had taken them, as well as the absence of evidence that they were safe and effective for treating the disease.

It wouldnt be surprising to see more companies and clinics showing up in the media and on cable television hawking unsubstantiated stem cell treatments for COVID-19. On May 4, the San Diego stem cell firm Giostar issued a news release asserting that it had received approval for a COVID-19 clinical trial using stem cells to treat COVID-19 patients, under the approval of the United States Food and Drug Administration (FDA) expanded access for compassionate use program.

Is this plausible? Weve reported before that Giostar had made untrue claims about its scientific connections: Several legitimate stem cell scientists the firm listed as members of its scientific advisory board said they had no connection with Giostar and had repeatedly asked that their names be removed from its website. The company has also acknowledged that it had exaggerated the professional credentials of its co-founder and chairman, Anand Srivastava.

Giostars claim in its news release that it would conduct the clinical trial under the FDAs expanded access for compassionate use program is curious. That program, which allows doctors to prescribe unapproved drugs as a last resort for people suffering from life-threatening diseases with no established cure, covers patients for whom enrollment in a clinical trial is not possible.

In other words, there doesnt seem to be such a thing as a clinical trial conducted subject to the expanded access program.

Giostar didnt respond to our request for comment. The FDA would say only that it generally cannot disclose information about an unapproved application, which certainly suggests that Giostar hasnt won the approval it claims.

In the frenzied search for COVID-19 treatments, it may be difficult to distinguish promising efforts from those just grasping at the main chance.

What we have right now is a COVID-19 gold rush, Turner says. Businesses are seeing this as a terrific opportunity to get their applications for investigative new drug trials approved by the FDA a process that can take years and generally requires the submission of extensive evidence from lab and animal studies.

The direct-to-consumer pitches by clinics reviewed in Turners paper typically fuse pseudoscience, which is what theyre offering, with more credible forms of science. He found numerous references in these pitches to research from China, often of doubtful scientific significance.

A Pennsylvania clinic offering stem cell treatment to support lung health during COVID-19, for example, cited a report from a Beijing hospital where seven patients were injected with stem cells all saw significant improvement in COVID-19 related pneumonia, according to the clinics press news . It quoted its CEO stating, This goes to support the wide range of healing and restoration that can be provided by (stem cell) therapy.

However, as Turner observes, the report didnt specify the severity of the subjects pneumonia, the source of the stem cells, or results from a control group. At best you can say that no one seemed to be harmed, but its hard to draw any firm conclusions about efficacy.

The Novus Center hangs its pitch on what Stephanie Wolff describes as a study thats ongoing in China right now using exosomes to help with viral load, to help with inflammation of the lung, to help with pneumonia, to help with infection.

The reference, however, is to a clinical trial in Wuhan that had not even begun to recruit test subjects at the time of its latest public report, which is dated Feb. 25. The researchers didnt expect their trial to be completed until July 31.

As weve written before, the proliferation of stem cell clinics selling untested and unlicensed therapies has been a public health crisis for years. The COVID-19 pandemic will only deepen the crisis as clinics add the coronavirus to their menu of treatment claims.

Despite its crackdown campaign, the FDA has never taken strong enough action against this corner of the healthcare industry. It should act without delay to shut down opportunistic initiatives, or more innocent Americans will find their health, and their pocketbooks, at ever greater risk.

2020 Los Angeles Times

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Mike Tyson lifts lid on training regime and stem-cell therapy ahead of comeback – Metro.co.uk

Iron Mike will break his soul to get back in peak physical condition (Pictures: Instagram / @MikeTyson)

Heavyweight boxing legend Mike Tyson has explained his gruelling training regime as he bids to return to the ring and says he is still feeling weird after using stem-cell therapy.

The 53-year-old showed off his incredible, age-defying speed and power in training footage he uploaded to Instagram last week, declaring he was back and ready to take part in exhibition fights for charity.

Iron Mike has already been inundated with potential challengers to fight, with old heavyweight rival Evander Holyfield posting his own video in response to Tyson and opening the door to a potential third fight between the pair.

Joe Rogan recently suggested that Tysons incredible speed and power was not down to natural hard work alone, and now the veteran boxer has revealed the extreme lengths he is going to in order to get back in shape.

Speaking on the Rock the Bells Radio show on SiriusXM, Tyson was asked by rapper LL Cool J how he would get in peak shape in just six to eight weeks and replied: Really I would just change my diet and just do cardio work. Cardio has to start, you have to have your endurance to go and do the process of training.

So something to do is get in cardio, I would try and get two hours of cardio a day, make sure you get that stuff in. Youre gonna make sure youre eating the right food.

For me its almost like slave food. Doing what you hate to do but doing it like its nothing. Getting up when you dont want to get up. Thats what it is. Its becoming a slave to life.

People think a slave to life is just enjoying drugs and living your life. Being a slave to life means being the best person you can be, being the best you can possibly be, and when you are at the best you can possibly be is when you no longer exist and nobody talks about you. Thats when youre at your best.

Probed further on the mental aspect of preparing for a fight, Tyson continued: My mind wouldnt belong to me. My mind would belong to somebody that disliked me enough to break my soul, and I would give them my mind for that period of time.

Six weeks of this and Id be in the best shape Ive ever dreamed of being in. As a matter of fact, Im going through that process right now. And you know what else I did, I did stem-cell research.

After LL Cool J asked if that meant Tysons white blood cells had been spun and then put back in, Tyson continued: Yes. As they took the blood it was red and when it came back it was almost transfluid [sic], I could almost see through the blood, and then they injected it in me. And Ive been weird ever since, Ive got to get balanced now.

Tyson first revealed that he had undergone stem cell treatment which is usually used to treat or prevent a disease or condition in an Instagram live chat with Shaquille ONeal earlier this month.

You know what I had done? I had stem cell therapy, said Iron Mike. I feel like a different person but I cant comprehend why I feel this way. Its really wild what scientists can do.

MORE: Evander Holyfield demands bizarre no knockouts rule for potential Mike Tyson comeback fight

MORE: Joe Rogan shocked by fu*king sensational training videos of Mike Tyson

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