Stem Cell Clinic

On the Road As a Stem Cell Courier – CSRwire.com

Even in times of the COVID-19 crisis, life-saving blood stem cells are brought to patients - by committed people like Maria

Apr. 27 /CSRwire/ - Originally published by DKMS

Maria Schmiing is a DKMS employee and has also been a volunteer stem cell courier for about two years. A few days ago, she took a transplant from Germany to the US - a particularly difficult challenge in times of the COVID-19 crisis. Currently, entry to the US is only possible because DKMS, with the support of the US Stem Cell Donor Register: National Marrow Donor Program (NMDP/Be the Match), has obtained a special permit for stem cell couriers to enter the country - so that patients can receive urgently needed transplants.

"It was through an acquaintance of mine that I became aware of it several years ago. She is a teacher and carries out stem cell transports during the school holidays - I was immediately enthusiastic about it and signed up for it," says Maria Schmiing from Cologne. She applied to Ontime Onboard Courier GmbH, one of the transport companies that DKMS works with to bring life-saving blood stem cells to the recipients.

Maria's first assignment took her to Leiden in the Netherlands - an important place in the fight against blood cancer, as the World Marrow Donor Association (WMDA) has its headquarters there. "I was really excited before I even started the journey," she recalls.

Afterwards many further assignments followed, and it was because of this job as a courier that her desire to work at DKMS was born. "For me, the circle is complete; I'm doing something meaningful with my life. I am very aware of what I am doing this for: for the patients who need our help. What I think is great is that I am also really supported by my team and my managers, especially in the current situation."

Blood stem cell couriers like Maria Schmiing are currently in great demand to ensure that blood stem cell donations reach their recipients all over the world safely, even during the COVID-19 crisis. A few days ago the latest task for the 34-year-old was to travel to the US. "The procedure for a courier mission is actually always the same," she explains, "During the briefing the day before, we go through all documents together and the entire itinerary is discussed. Everything important detail is marked and addressed." But something is different at the moment: the couriers must carry a special permit that allows them to enter the US. "This must be presented upon entry and exit."

The next stop for Maria was the collection centre the next morning. There she received the life-saving blood stem cells from specially trained staff. These had previously been collected from a DKMS donor and prepared for transport. All documents and data were double checked based on the 4 eye principle before the transplant was handed over. "We especially look at the donor number and compare it, because we have to make sure that the patient receives the right transplant".

Afterwards Maria could start her journey. Stem cell couriers are allowed one additional piece of hand luggage only to be able to stay flexible on the way. "Most important are the blood stem cells or the bone marrow. We must not lose sight of the transplant during the entire journey. I look after this suitcase like my own personal treasure, like a mother who looks after her children. I am aware of the responsibility I carry and this stays with me until I have delivered the blood stem cells safely to the patient's clinic."

Before the departure to the US, she made sure that at the Frankfurt Airport the suitcase with the stem cells was not X-rayed. "I always explain that this is harmful to the transplant something most people know. Only after an officer has brought the suitcase through the security area, do I then follow. This is the only time we hand the suitcase over to somebody else. Fortunately, there were no problems either at the security check or at customs.

Once on the plane she informed the crew - an important and regular task for her - and did not let the suitcase out of her sight during the flight. "Sleep, of course, is out of the question. We are not allowed to drink alcohol 24 hours before and during the flight and we of course have to take the suitcase everywhere with us."

Upon arrival in the US, Maria noticed two differences "After landing, several security officers entered the plane and talked to the crew - only then were we allowed to disembark. In addition to this, they took the temperature of all passengers.

She then continued her journey by taxi to the transplant clinic. "Everything went really well, and I was met at the clinic by a member of staff. Again there, we double checked everything and went through the documents according to the four eye principle. Once we get back to Germany, there is also a debriefing and I then return the suitcase."

After handing a transplant over, there is always a moment of great relief for Maria: "The tension disappears. Afterwards she has a ritual, which is very important for her. "I go to the hotel, have a shower and then go out and raise a glass of beer for the patient. I think about how they are doing and what is still ahead of them. I then tell myself that from my side I've done everything I can to help them and I wish them all the best."

Going out and having a beer was not possible this time, as neither shops nor bars were open in the American city - even the hotel restaurant was closed. "I changed my ritual and toasted the unknown patient with a glass of tap water in my room!"

The next day she went back to Germany and soon the next flight will be scheduled for her - couriers are rare in this COVID-19crisis-ridden time. "My learning from this journey: I will take an emergency ration of trail mix with me, you never know," she says with a wink. She reflects on her commitment to patients. "I am still available when my help is needed. I am aware of the risk and take the best possible care and comply with all safety precautions. It is also clear that patients cannot wait - and despite everything with the current situation they should still be given a chance at life.

Learn more about how you can help deleteblood cancer atDKMS.org

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On the Road As a Stem Cell Courier - CSRwire.com

You could be someones only hope: A stem cell donor campaigning to beat blood cancer – Evening Standard

The latest headlines in your inbox twice a day Monday - Friday plus breaking news updates

A stem cell donor is urging people to sign-up after registration numbers drop by more than 50 per cent from this time last year.

Lockdown was the last thing on Sam Schmidts mind when he got the call to say that they had found a match and he was going to be the donor.

He had been expecting that call since his registration last year.

While most of us would have had second thoughts about going through with the process in the middle of a pandemic, the brave 24-year-old took the risk.

Sam Schmidt at the London clinic where he underwent the procedure (DKMS)

Accompanied by his parents, Sam went to the London Clinic this week to undergo the live-saving procedure to donate his stem cells to an anonymous patient with blood cancer.

You could be someones only hope. That really hit home for me especially when I got the call.

"I thought that Im definitely going to do this now because If I dont, Im essentially sentencing someone to a far less chance of survival. If you are someones match then thats an actual individual relying on you.

He registered with the charity DKMS - known as We Delete Blood Cancer - after meeting Peter McCleave, a 42-year-old father of two who was diagnosed with the condition shortly after running an Ironman Triathlon.

Hes one of those people that you meet and youre like, how on earth is someone as fit and healthy has him got blood cancer?

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You could be someones only hope: A stem cell donor campaigning to beat blood cancer - Evening Standard

David C. Karli is Offering a New Ray of Hope Through Regenerative Medicine – RESPECT.

Earlier, treating orthopedic problems just led to temporary cure but not the root cause of the problem. However, the case is not the same now. With emerging research and experience, Dr. David C. Karli says that regenerative medicine can completely repair the tissues using stem cell therapies. From professional athletes to ordinary people who strive to live a healthy and active life, regenerative medicine is a new ray of hope providing a healthy alternative for sports and musculoskeletal conditions and injuries.

Dr. David C. Karli is an Ivy-trained physician, a pioneer in orthopedic regenerative medicine and sports medicine, and the founder of Greyledge Technologies, one of the first FDA-audited biotech companies that prepare biologic implants to repair humans diseased or damaged tissues. Talking about the advancements in regen medicine, he says, Regenerative medicines multidisciplinary approach can cater to solutions for several untreatable orthopedic problems. With experts around the world pooling their knowledge, skills, and resources, a breakthrough in orthopedic treatment is leading to a miracle cure.

What is Regenerative Medicine?

Regenerative medicine is an interdisciplinary field that helps repair or replaces damaged or diseased human cells or tissues to restore normal function. The relatively new field of study comprises a broad range of scientific disciplines like molecular biology and genetics to immunology and biochemistry. Dr. Karli specializes in orthopedic applications where a patients diseased cells are replaced and re-implanted by the autologously collected healthy cells from the same patient.

About Dr. David C. Karli

Dr. David Karli graduated from Elizabethtown College, Pennsylvania, in 1993. Followed by receiving his MD degree from the University of Maryland, he pursued his residency in physical medicine and rehabilitation at Harvard Medical School, where he served as a chief resident in his final year. While serving as an attending physician at Harvard Medical School, Dr. Karli collaborated with his orthopedic surgeon colleagues and participated in the development of rehabilitation protocols for spinal disorders. He joined the Steadman Clinic in Vail, Colorado, where his research interest led him to take up Regenerative Medicine and successfully launch and develop Greyledge Technologies. This company focuses on autologous blood-based biotherapies for orthopedic injuries.

In his 23 years of experience, Dr. Karli has authored several research papers and publications on stem cell therapies and rehabilitation and lectured on spinal and musculoskeletal topics. He is a Diplomate of the American Board of Physical Medicine and Rehabilitation. Also, Dr. Karli is an active member of several societies, including the Regenerative Medicine Organization., the American Academy of PM&R, and the International Spinal Injection Society.

Greyledge Technologies

He founded the company Greyledge Technologies in 2010 with the mission to redefine orthopedic treatments and enhance the bodys response to injury. Greyledge Technologies develops biologic products by processing materials like human blood and bone marrow into implantable preparations. These biologic preparations are further developed and inserted into the human body replacing the diseased cells hence, stimulating the healing process and self-repair.

At Greyledge Technologies, every patient is completely assessed and analyzed not only to guarantee that theyre fit to undergo the procedure yet additionally to create a personalized dynamic strategy that each patient can follow. The whole treatment takes a certain number of days wherein the family members and caretakers are informed about the medicinal dosages to follow after the procedure. After surgery, every patient is regularly followed-up by the rehabilitation team.

When asked in-depth about practicing regenerative medicine at Greyledge Technologies, Dr. Karli said, The treatment is entirely safe and effective as it requires no big surgeries or complicated operations. As the cells used are autologous, they do not pose any chances of immune rejection or untoward irreversible side effects. Neither do the cells need to be preserved. This makes the procedure swift and safe for all ages.

Dr. Karli says, Regenerative Medicine is emerging as one of the trending treatment options for patients who have lost all hope. Whats brilliant about this treatment is that it has the capability to thoroughly repair the damaged tissues at the molecular, structural, and functional level.

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David C. Karli is Offering a New Ray of Hope Through Regenerative Medicine - RESPECT.

FDA Expediting Accelerated Development of Novel Therapies for COVID-19 – PR Newswire UK

PALM BEACH, Florida, April 28, 2020 /PRNewswire/ --The U.S. Federal government is working closely with companies and researchers to find treatments and vaccines to overcome the global health crisis. The FDA has been cutting red tape and has launched new programs that relax certain time consuming regulations while still assuring the efficacy and safety of the treatments. The FDA recently issued an update describing its most recent programs. The update stated that, as part of the administration's: " all-hands-on-deck approach across public, academic and private sectors to combat the COVID-19 pandemic, the U.S. Food and Drug Administration stood up a new program to expedite the development of potentially safe and effective life-saving treatments. The program, known as the Coronavirus Treatment Acceleration Program (CTAP), is using every tool at the agency's disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus. Active healthcare stocks in news today include: Citius Pharmaceuticals, Inc. (NASDAQ: CTXR), Mesoblast Limited (NASDAQ: MESO), Inovio Pharmaceuticals, Inc. (NASDAQ: INO), Gilead Sciences, Inc. (NASDAQ: GILD), Aytu BioScience, Inc. (NASDAQ: AYTU).

"The FDA is announcing a new, comprehensive public-private approach to bring coronavirus treatments to market as fast as possible," said HHS Secretary Alex Azar. "As part of this new program, the FDA is cutting red tape, redeploying staff and working day and night to review requests from companies, scientists and doctors who are working toward therapies. We are grateful to the men and women of the FDA who have been working in concert with industry and other parts of HHS to support potential coronavirus treatments for weeks now. Each day, President Trump's all-of-America approach is making progress and providing new hope in our fight against the coronavirus."

There are a large number of companies and researchers developing and evaluating COVID-19 related therapies. Given the urgent nature of the pandemic, under the FDA's accelerator program, staff from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research are providing regulatory advice, guidance and technical assistance as quickly as possible. As part of this work, the FDA is triaging requests from developers and scientists seeking to develop new drug and biologic therapies, getting the relevant FDA staff in touch with them and providing rapid, interactive input to get studies underway quickly.

Citius Pharmaceuticals, Inc. (NASDAQ: CTXR)BREAKING NEWS - Citius Announces Pre-IND Submission to FDA Under the Coronavirus Treatment Acceleration Program for a Novel Stem Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 - Citius Pharmaceuticals ("Citius" or the "Company"), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, this week announcedthat it submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ("CBER") of the FDA under the Coronavirus Treatment Acceleration Program (CTAP) on April 24. The Company has requested the Division's feedback to support the most expeditious pathway into the clinic to evaluate a novel cell therapy in patients suffering from COVID-19-related ARDS.

The cells, called NoveCite Cells or NC-MSCs, are made by Novellus, Inc. ("Novellus"), a Cambridge-based biotechnology company, using its patented mRNA-based cell-reprogramming process. NC-MSCs are mesenchymal stem cells derived from a single donor's fibroblasts that have been dedifferentiated into an induced pluripotent stem cell (iPSC) master cell bank, thereby avoiding the need to source additional donor cells. The iPSCs are then further differentiated into a mesenchymal stem cell (MSC) therapy. Citius and Novellus plan to develop NC-MSCs for the treatment of ARDS, and last month the companies signed an exclusive option agreement.

The Company plans a multi-center randomized placebo-controlled dose-finding study followed by an expansion phase to assess the safety, tolerability, and efficacy of NC-MSCs in patients with moderate to severe ARDS due to COVID-19. The proposed trial, a Phase 1b/2 clinical trial, is titled "A Randomized Placebo-Controlled Dose-Finding Study Followed by a Dose Level Expansion to Assess the Safety and Efficacy of NoveCite MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to SARS-CoV-2 Disease (COVID-19)," or "MARCO". The primary objectives of this study are to evaluate the safety and efficacy of NoveCite cells as a treatment for subjects with moderate-to-severe ARDS due to COVID-19 and to identify therapeutic doses.

"MSCs have an established track-record of clinical safety, and have shown promise in the treatment of inflammatory lung disease," said Matt Angel, PhD, co-founder and Chief Science Officer at Novellus, Inc. "Our research has shown that the NoveCite cells, being derived from mRNA-reprogrammed iPSCs, secrete higher levels of immunomodulatory proteins than donor-derived MSCs, and have unique manufacturing advantages."

"We believe we have the key elements in place from a clinical design and manufacturing point of view to evaluate this novel cell therapy approach to deal with the current pandemic," said Myron Holubiak, Chief Executive Officer of Citius. "ARDS is a very serious complication for many patients suffering from COVID-19, and is believed to account for about 80% of the deaths in ventilated patients. There is no proven or FDA-approved treatment for it, other than oxygen therapy, including use of mechanical ventilation, and fluid management. Literature from previous investigational studies with MSCs in the treatment of lung injuries support the idea that MSCs could prove effective in treating COVID-19-related ARDS. We look forward to our FDA discussions and are excited to be at the cusp of what could be a novel and effective therapy for ARDS." Read this full release at: https://ir.citiuspharma.com/press-releases/detail/96/citius-announces-pre-ind-submission-to-fda-under-the

In other healthcare news of note:

Mesoblast Limited (NASDAQ: MESO) recently announced 83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast's allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days. 75% (9/12) have successfully come off ventilator support at a median of 10 days. At this time, seven have been discharged from the hospital. Patients received a variety of experimental agents prior to remestemcel-L. All patients were treated under an emergency Investigational New Drug (IND) application or expanded access protocol at New York City's Mt Sinai hospital.

In contrast, only 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with standard of care during March/April 2020.

Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced this week that first quarter 2020 financial results will be released after the market close on May 11, 2020. Following the release, the Company will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and provide a general business update, including the company's ongoing vaccine developments for COVID-19. A live and archived version of the audio presentation will be available online at http://ir.inovio.com/investors/events/default.aspx. This is a listen-only event but will include a live Q&A with analysts. Telephone replay will be available approximately one hour after the call at 877-344-7529 (US toll free) or 412-317-0088 (international toll) using replay access code 10143530.

Gilead Sciences, Inc. (NASDAQ: GILD) Kite, a Gilead Company, and oNKo-innate recently announced the companies have entered into a three-year cancer immunotherapy research collaboration to support discovery and development of next-generation drug and engineered cell therapies focused on natural killer (NK) cells.

Current cancer immunotherapy approaches primarily focus on T cell mediated anti-tumor immunity, including checkpoint inhibition and chimeric antigen receptor (CAR) T cell therapy. Like T cells, NK cells are a class of lymphocytes (white blood cells) that play a critical surveillance and effector role in the immune system. NK cells and T cells each have the potential to attack cancer cells, but have different mechanisms for tumor cell killing. Thus, appropriately activated and targeted NK cells may represent a differentiated approach that would be potentially complementary and synergistic with T cell mediated anti-tumor strategies.

Aytu BioScience, Inc. (NASDAQ: AYTU) recently announced that it has signed an agreement with Sterling Medical Devices ("Sterling") to finalize the development of Healight, a novel endotracheal catheter, as a potential treatment for coronavirus.

The company announced last week that it licensed exclusive worldwide rights to the Healight technology from Cedars-Sinai for all endotracheal and nasopharyngeal indications. The patent-pending Healight Platform has been in development since 2016 by the Medically Associated Science and Technology (MAST) team at Cedars-Sinai. Following their pre-clinical findings that Healight may be a safe and effective antiviral and antibacterial treatment, the team engaged Sterling to rapidly develop a novel endotracheal device to help combat coronavirus.

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FDA Expediting Accelerated Development of Novel Therapies for COVID-19 - PR Newswire UK