Is Alzheimer’s treatment of injecting stem cells into the brain a breakthrough or quackery? – The Keene Sentinel

IRVINE, Calif. More than eight years after he realized something was wrong, after, as he described it, My brain went ... whats the word? ... Foggy, Jack Sage finally said after several seconds of silently coaxing his synapses to fire.

More than eight years after his brain went foggy, four years after he was diagnosed with Alzheimers disease and two years since he began an innovative and extremely invasive therapy, Sage said he is being flooded by memories that seem new, or, at the very least, feel easier to retrieve. His daughter, Kate, thought Sage had suddenly begun to open up about his past because he knew his time was growing short.

He should not know who I am at this point, Kate said.

His doctor, Christopher Duma, hopes Jack Sage goes down in history as the one-man turning point in the treatment of Alzheimers disease, while others are skeptical about what Duma has done to Sages brain. Everyone agrees that Alzheimers disease is an exploding problem.

According to the Alzheimers Association, more than 5 million Americans are living with the disease, and 1 in 3 seniors die with Alzheimers or another form of dementia.

On a cool recent night, Sage, a handsome, fit, 82-year-old, sat next to his wife Gloria talking about his children (It is significant that Sage remembers their names James, 46, Kate, 50, and Kelly, 56), recalling when he and Gloria moved into the Newport Beach house with a view of the Pacific Ocean (1990), laughing about their first date at the Bel-Air Country Club (1979), recounting his years as a labor negotiator and executive for Del Monte, Allied Chemical and Continental Airlines (1970s and 60s) and going all the way back to the jack hammering he did in the nickel mines in the mid-1950s in Northern Ontario, Canada.

At this point in his illness, his doctor said he should be having more trouble remembering the perilous tunnels of the Sudbury nickel mine.

You drill into the granite, Sage said. You put dynamite in the rock. You dynamite it. Then you shovel out whats left.

And mining, you might say, is what is happening in Jack Sages brain.

Sages series of recollections, including his exploits on the golf course in Indian Wells where he has a second home and plays several days a week flashbacks representing the three main components of long-term memory: semantic (recalling the meaning of words), episodic (recalling autobiographic milestones) and procedural (recalling how to accomplish tasks) prompted a grin from Duma, the brain surgeon who, for $10,000 per treatment and without insurance coverage, cut a hole in the back of Sages head and injected a stem cell serum that had been sucked out of Sages love handles.

Is this the Alzheimers breakthrough the world has been waiting for? Or, is this unproven medical procedure what University of Minnesota bioethicist Leigh Turner calls quackery and flimflam? Is this an unsafe, money-grab it is being conducted outside the approval process of the Food and Drug Administration preying on the most vulnerable among us?

Turner has written extensively and critically about the Cell Surgical Network (CSN), for which Duma, whose home hospital is Hoag in Newport Beach, is listed as a network physician. The CSN promotes the stem cell revolution, which its literature claims, is an appropriate treatment for people suffering from a variety of inflammatory and degenerative conditions in other words, for cancer, diabetes, bad knees and hips as well as multiple uses in cosmetic surgery.

You dont just start dumping things into peoples brains, Turner said. The problem is people may spend a lot of money and find there is no benefit. He (Duma) is exposing people to serious harm. Fat cells dont belong in peoples brains.

Sage is the first patient in Phase I of a clinical study officially called Intracerebroventricular injection of autologous abdominal fat-derived, non-genetically altered stem cells. Sage was the first Alzheimers patient anywhere to have his own liposuctioned cells injected directly into his brain. He has received eight injections (about two months apart) since November 2014.

Duma quickly offers a qualifier. It is far too early to tell if what he has done to Sage will indeed change the world. He said Sage and, later, 19 other patients have not been harmed by the procedure, and that safety is the only criteria in Phase I. Whether the treatment is effective is a question for Phase II, for which Duma is hoping to attract private funding. Also, he wrote a letter to the national Alzheimers Association asking for $700,000 to continue his work. He was instructed to apply officially later this year. If he gets the grant, the fees for his patients would be waived.

Early in the process, Duma is excited by Sages results.

Sages most recent cognition scores have risen from 45 on the 100-point Memory Performance Index in March 2015 to 54 in September 2015. The volume of his hippocampus the memory center of the brain has grown from the fifth percentile before his first treatment to the 28th percentile after his fourth treatment to the 48th percentile after his eighth treatment.

My golf game is getting better, said Sage, who, heart permitting, plays several times per week. Sages brain isnt his only problem. He has a long history of heart ailments that have required the insertion of 12 stents to keep his arteries open.

You cant make a global conclusion based on one patient, but its a huge turning point, Duma said with the confidence of someone who probes brains for a living.

Duma is somewhat of a maverick in the medical world, a brain surgeon who regularly shuns a scalpel for the gamma knife, a futuristic laser for removing brain tumors. He is known outside the operating room for playing keyboards in bands that specialize in 1970s-era covers of groups such as Genesis, Yes and Emerson, Lake and Palmer. As a child, he was a classmate of John F. Kennedy Jr. at The Browning School in New York City. We called him John John, Duma said.

Duma realizes he will face opposition to his stem cell/brain injection therapy. But, as in all breakthroughs, someone has to be first.

I could have harmed people, he said. I took an enormous leap.

Not much hope

Alzheimers patients dont get better.

They get diagnosed, lose their dignity and die.

The speed at which death occurs is the only variable.

In the depressing world of Alzheimers treatment, Sage and Duma represent equal parts hope and skepticism. The Orange County Register contacted universities and research centers across the country, including Stanford, Harvard, Duke, Florida International, UC Davis, and some of the interview requests were denied while other calls were not returned. Very few medical experts want to talk about the combination of stem cells and Alzheimers disease, apparently because they know so little about it.

An Alzheimers patient improving because of therapy? Im hopeful its true. Im hopeful its true for all patients, said Joshua Grill, the co-director of the Memory Impairments Neurological Disorders (MIND) institute at UC Irvine. We are in dire need.

But, Grill continued, One study does not a revolution make. Ive never read anything about this (Dumas work), and I dont know what science is behind it.

Dean Hartley, Director of Science Initiatives at the Alzheimers Association, knew about Dumas work.

This is new territory, Hartley said. But with one patient, No, you cannot say this is a game-changer.

Hartley said many studies fail at the Phase II level, where more and more people are exposed to the therapy.

Still, Hartley said Dumas work is encouraging.

We want to see things like this happen, Hartley said.

Its not as if Duma is conducting his research in secret. He spoke about his study in public forums twice last year Sept. 28 at the Congress of Neurological Surgeons in San Diego, and Oct. 1 at the International Society for Cellular Therapy in Memphis.

Duma said he is nearly finished writing a paper about his work that he hopes will be published in a peer-reviewed journal.

THE STEM CELL IDEA

In 1993, Christopher Duma was working at Good Samaritan Hospital in Los Angeles when he and his colleagues began injecting stem cells into the brains of patients with Parkinsons disease. They were making some progress, he said, but politics intervened. Some of the stem cells they were using came from aborted fetuses. Pressure from anti-abortion groups shut that program down.

Fifteen years later, Duma was assisting plastic surgeon Michael Elam on a face-lift on a Parkinsons patient when Elam said, We need to talk about stem cells.

Elam introduced Duma to Drs. Mark Berman and Elliot Lander, the founders of the Cell Surgical Network.

Berman and Lander had been separating stem cells from fat by using a centrifuge (which they own the patent for) and injecting them into knees and hips and other places where injuries had occurred. Their work had passed an Institutional Review Board after 1,524 patients were treated with no adverse effects, Berman said.

If you want to repair an injury, Berman said, the best tissue is the stem cell.

In 2013, Duma suggested a new target for stem cell therapy: the brain.

Duma, with Berman, Lander and Elam as co-authors, tried to begin a study of brain/stem cell injections. But their first attempt at Institutional Review Board approval was denied because they hadnt done animal testing. So they got Dr. Oleg Kopyov at Cal State Northridge to conduct tests on rats.

With the help of Kopyovs work, Duma got Institutional Review Board approval. They chose not to take the usual next step FDA approval.

The Institutional Review Board was expecting us to go through the FDA, Lander said. But there are hundreds of obstructions. The FDA approval process usually takes between eight and 12 years, according to the online journal Medscape.com.

Duma said stem cells present a quandary for the FDA because stem cells are not a drug, and theyre not food. Clinics that take stem cells out of the body and put them back in without additives argue that they are exempt from FDA mandates.

We have been harvesting fat from abdomens and putting them in the brain during brain surgeries since the 1920s, Duma said. We do it nearly on every case for pituitary tumors, acoustic and skull base tumors and for conditions of spinal fluid leakage ... since the 1920s. If the FDA ruled that harvested autologous fat cannot be used in the brain, then it would change nearly a century of neurosurgical standard of care.

Someday, Duma said he hopes the FDA will recognize his work.

The work cant wait, he said.

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Is Alzheimer's treatment of injecting stem cells into the brain a breakthrough or quackery? - The Keene Sentinel

The Amazing Power of Stem Cells – Miami’s Community Newspapers

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Two days ago, I read a letter from my colleagues at the American Association of Pain Management Physicians, which reported that as of July 2016 (in the state of Oregon), blockages to control pains were denied coverage by several insurance companies. Instead, the Oregon health authorities have recommended the use of therapeutic massages and acupuncture in lieu of blockages.

This decision is unfortunately no joke, but rather only one of many examples of an oblivious and retrograde type mentality, and basically serves to clearly demonstrate how our great country continues to lose ground every day in the healthcare arena. Regrettably, this antiquated mindset ultimately causes mediocrity to take over many of our medical institutions, under the indifference of many and under the complicity of others.

With all due respect to the ancient art of acupuncture and the technique of therapeutic massages, these treatments are only proven to represent a viable (temporary) alternative for moderate pain control, but never as a true solution to treat any type of chronic pain.

I have spent almost 15 years researching new alternatives for the treatment of chronic and perennial pain. I have explored many treatments from blockages, therapies, pills and injections, to what I now call: The Medical Revolution of the 21st Century: Stem Cells.

If someone would ask me: Why use stem cells? I would explain to them that it is a very effective way to control pain, and is a medical treatment alternative that is basically unparalleled nowadays. These incredibly powerful cells, of which our body is organically armed with from birth, have the important function of regenerating and repairing damaged tissue, regardless of race, gender, ethnicity, or even age.

For example, last week I met with Berthy, a 65-year-old woman treated with a successful marrow and fat stem cell transplant to treat her severe arthritis related knee pain we conducted about four months ago. During her visit, Berthy recounted that she had recently accompanied her husband to a renowned clinic in South Florida, where the issue of stem cell use had arisen, and the doctor at the medical institution had told her: they only work on patients up to 50 years old. She immediately showed him her knee and told him that at age 67, she was perfectly fine after her recent stem cell transplant. The doctor was astonished, and with a shrug he replied, they must know more and have more experience than we do in that area. Berthy is currently arranging a trip with her husband to travel to Asia and realize their dream of walking The Great Wall of China.

We as a society must begin to think big, and focus on the future and support the latest advances of modern medicine. Also, we as patients should demand the right to be offered the most advanced treatments and not simply resign ourselves to a health authority mandate or a medical professional that would impose an ineffective or mediocre type treatment.

We could speculate on the reasons behind the Oregon insurance situation, but the reality is that it is far better to look to the future and demand the option of extensive stem cell application, recognizing it as a feasible and true solution to treat arthritis of the joints and the spine. To that fight, which is really thinking big we must all unite!

So if you, a family member, or friend need to be evaluated to find out if Stem cell treatments are a viable option, please call us at 305-598-7777. Remember that by mentioning this article the first consultation is free. If you want to contact the doctor directly, please do so via email: stemdoc305@gmail.com or for more information visit our website: http://www.stemcellmia.com or follow us on our Facebook Page and Twitter @StemCellMia or you can also watch our amazing testimonial videos on our YouTube channel.

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The Amazing Power of Stem Cells - Miami's Community Newspapers

Stem cell therapy shows promise in treating spinal cord injuries, Canadian study – Cantech Letter

Spinal cord injuries are among the most dramatic and devastating of all injuries, in part because they stem from traumatic accidents but also because there are very few treatment options.

While medical advances have been made in the areas of injury management and improved long-term functioning, for those dealing with spinal cord injuries the sad truth is that researchers have yet to come up with a cure for paralysis.

Victims of spinal cord injuries are left facing a lifelong disability, one that comes not only with a range of personal burdens but which also extracts its toll on the healthcare system studies have shown that the lifetime economic burden of spinal cord injuries in Canada ranges between $1.5 to $3.0 million per individual.

Yet cell therapies represent one area of current research that appears likely to deliver positive results. According to a new study from researchers with the University Health Network and the University of Toronto, the neuroregenerative potential of this approach is promising.

Cell therapy, which in general refers to any procedure involving the implantation of cells, comes in different guises in spinal cord research, depending on the type of cells employed. Clinical research is already being performed using stem cells, which have the ability to self-renew and to differentiate into a variety of specialized cells, and glial cells, which support neural functioning.

The aim in both cases is to introduce the new cells so as to encourage regrowth of nerve fibres where they have been severed and thereby restore nerve function, a seemingly impossible task, since along with the structural damage caused by spinal cord injury comes a series of secondary events such as scarring and inflammation which, although normal bodily repair processes, can effectively impede the chances at regrowth and reconnection of neural networks.

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Reviewing the current state of affairs in spinal cord research, the researchers find that cell therapies, especially those that combine more than one approach, are showing promise but need further study and clinical trials. While combinatorial treatments using cell-coupling, trophic factors, biomaterials, and rehabilitation, may help to improve stem cell effectiveness among a heterogeneous patient population, there is still much research required to optimize their application, say the studys authors.

The researchers found that in early clinical trials, for example, cell therapies have shown modest improvements connected to functional recovery, yet they say that the results are encouraging and that even slight enhancements in sensation and function for those dealing with spinal cord injuries are often quite meaningful. It is clear that a lot remains to be understood in the translation of stem cell therapies, say the studys authors. However, given the significant strides in laboratory work, we should not lose sight of their potential.

The new research is published in the journal Expert Opinion on Biological Therapy.

The primary causes of spinal cord injuries are motor vehicle accidents and unintentional falls, each accounting for a little over 40 per cent of spinal cord injuries. According to Spinal Cord Injury Ontario, there are 1,500 new spinal cord injuries each year and a total of 86,000 Canadians currently living with spinal cord injuries.

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Stem cell therapy shows promise in treating spinal cord injuries, Canadian study - Cantech Letter

Three women blinded by unapproved stem-cell ‘treatment’ at South Florida clinic – Washington Post

Three women with macular degeneration became permanently blind after undergoing anunproven stem-cell treatment touted as a clinical trial at a South Florida clinic. Medical experts said the episode raises questions about whether the government and doctors are doing enough to protect patients from the dangers of unapproved therapies.

The episode, described Wednesday in an article in the New England Journal of Medicine, represents one of the most egregious examples of patient injury involving a stem-cell clinic. These facilities have sprung up by the hundreds across the country over the past several years. Many offer supposed experimental treatments for ailments ranging from hip problems to autism to ALS.

Of special concern, said Jeffrey Goldberg, professor of ophthalmology at the Stanford University School of Medicine and one of the authors of the report,was the clinic's ability to list its study on a comprehensive database of clinical trials called ClinicalTrials.gov, which is run by the National Institutes of Health. At least one of the patients and maybe more believed that she was taking part in a government-sanctioned study, he said.

Goldberg called the incident a wake-up call across the spectrum for patients, physicians and government regulators. Surely, he said, it's an opportunity for the FDA to increase patient safety for these unapproved clinical trials.

Thomas Albini, a University of Miami ophthalmologist and another one of the authors, said that he and his colleagues at the Bascom Palmer Eye Institute had treated two of the patients for severe complications in 2015, shortly after they had undergone the stem-cell procedures at a clinic in Sunrise, Fla. The severe complications included detached retinas, hemorrhages and vision loss.

It's a disaster, Albini said, noting that the patients, before the stem-cell treatments, had only moderate vision loss. Buyer beware:These stem-cell clinics that function in this very unregulated way are doing procedures that are not approved and they can be quite dangerous.

The NEJM article did not identify the clinic or the patients, but its listing on the ClinicalTrials.gov website shows the sponsor as Bioheart Inc., also known as U.S. Stem Cell Inc., and says that the study was withdrawn before patients were enrolled. The clinic still has other stem-cell studies listed on the site, including for chronic obstructive pulmonary disease and degenerative disc disease.

[Stem-cell clinics face new scrutiny from regulators]

Repeated calls to U.S. Stem Cell and to Kristin Comella, who is listed as the chief scientific officer, have not been returned. In a NPR story last year, Comella said that two of the clinic's patients had suffered detached retinas following treatments, prompting the clinic to stop doing eye procedures.

According to Florida court filings, two of the patients involved, ages 72 and 78 at the time,sued the clinic and some individuals involved in the procedures. Their attorney, Andrew Yaffa of Coral Gables, said that the case was resolved to the mutual satisfaction of the parties but that neither he nor his clients could comment beyond that.The third patient was an 88-year-old Oklahoma resident who sought medical help a week after the stem-cell procedure at the Dean McGee Eye Institute in Oklahoma City.

Albini said the eye damage could have been the result of contamination during preparation of the stem cells. He also said it was possible that the stem cells could have changed into cells that are associated with scarring.Even if the solution had been prepared correctly, he said, there's no evidence that it could have helped restore the patients' vision.

Albini said the three patients paid $5,000 each for the stem-cell procedure, which involved conducting mini-liposuction procedures to remove fat from the abdominal area, isolating the stem cells from the fat and injecting those cells directly into eyes. Charging the patients was a red flag, he said, that this was not a traditional clinical trial. A second was treating both eyes at the same time, rather than seeing how one eye responded before treating the other.

[Huge NIH clinical-trials data base lacks key details.]

Age-related macular degeneration is the leading cause of vision loss in people older than 75 in the United States. While researchers are making tremendous progress using stem cells to treat the disease, the field requires careful study with meticulously designed trials, the authors of the paper said. The FDA has approved only a few stem-cell therapies, mostly for blood disorders.

The proliferation of stem-cell clinics there are more than 570 of them, according to a study published last year has ignited a fierce debate among physicians, patients and scientists about how they should be regulated.FDA rules allow the use of patients' own stem cells for treatments, without agency approval, but only if the procedures meet stringent conditions. The stem cells, for example, cannot be more than minimally manipulated and must be intended for the original function. That would not typically include using stem cells from fat to repair eye cells.

Albini said that the FDA had started an investigation into the case but a spokeswoman said the agency does not discuss potential or ongoing investigations. She added that consumers are encouraged to contact the FDA and state authorities to report any potentially illegal or harmful activity related to stem-cell-based products. The FDA has issued several drafts of guidance for the stem-cell industry to try to outline its thinking on the matter, but the documents have not been finalized, and many clinic operators oppose FDA regulation.

[Unregulated stem-cell clinics are proliferating across the United States.]

Paul Knoepfler, a stem-cell scientist at the University of California at Davis who is a frequent critic of the clinics, said he didn't understand why the FDA and the NIH have not moved more aggressively to ensure patient safety.

It's puzzling and concerning, he said. He said that allowing the clinics to list their trials on ClinicalTrials.gov is almost like a form of advertising for products that don't have FDA approval. That's really problematic.

In a statement, the NIH said that the information on ClinicalTrials.gov is provided by study sponsors and thatposting on the site doesn't reflect endorsement by the NIH, which doesn't independently verify the scientific validity of the trial. It also said that every study includes links to an NIH disclaimer. However, we agree that such caveats need to be clearer to all users and we will be adding a more prominent disclaimer in the future.

Read more:

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Three women blinded by unapproved stem-cell 'treatment' at South Florida clinic - Washington Post

Blinded by science: Women go blind after stem-cell treatment at Florida clinic – Palm Beach Post (blog)

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Three women reportedly went blind after a stem cell treatment at a Florida clinic.

Whats more is that at least two of the women had gone to the clinic because it was listed as a macular degeneration study on a federal database.

Doctors call the incident an example of how risky such clinics can be.

News reports from The Associated Press, The New England Journal of Medicine and others say that a clinic the experimental procedure occurred was in Sunrise, Florida run by U.S. Stem Cell Inc.

Age-related macular degeneration can rob a person of their central vision.

The women were injected in their eyes with a cell preparation derived from her own fat tissue.

Ophthalmologist Dr. Thomas Albini of the University of Miami, who examined the women, said one woman is totally blind and the others legally blind. He said all suffered detached retinas.

These women had fairly functional vision prior to the procedure and were blinded by the next day, Albini said.

The clinics method hasnt been proven effective or tested for safety in people, he added.

Its very alarming to us as clinicians that somebody would do this to both eyes at the same time, said Albini.

Dr. Thomas Albini of the University of Miami.

Elizabeth Noble, one of the women said she was diagnosed with age-related macular degeneration that blurs the central vision. The former educator said she heard about the treatment at the clinic for a research study described on ClinicalTrials.gov, a website run by the National Institutes of Health.

The former educator said she heard about the treatment at the clinic for a research study described on ClinicalTrials.gov, a website run by the National Institutes of Health.

Its very easy to register studies on ClinicalTrials.gov and essentially use a government website as a marketing device, Leigh Turner, a bioethicist at the University of Minnesota, told BuzzFeed News.

Noble went to the clinic in June 2015 where staff took fat from around her belly button, extracted those cells and mixed them with Nobles blood plasma. They then injected it into both her eyes for $5,000, according to a story in Buzzfeed.

In an editorial accompanying the Journals report, stem cell expert Dr. George Daley, dean of Harvard Medical School, called the clinics treatment careless.

This report joins a small but growing medical literature highlighting the risks of such wanton misapplication of cellular therapy, he wrote. Providing such treatments for profit outside a proper research setting is a gross violation of professional and possibly legal standards, he said.

Buzzfeed reports this isnt the first time experimental procedures at a clinic have gone awry.

In 2010, for example, a woman with the autoimmune disease lupus died after her own bone marrow cells were injected into her kidneys at a clinic in Thailand.

In 2013, the Florida Department of Health revoked the medical license of Zannos Grekos over the death of a 69-year-old woman. He had extracted material from her bone marrow, filtered it, and then infused it into the arteries feeding her brain. The woman had a stroke.

Treatment for age-related macular generation is at the center of the Medicare fraud trial in West Palm Beach of Dr. Salomon Melgen, who happens also to be tied to a bribery scandal involving a U.S. senator.

Read The Palm Beach Posts coverage of the fascinating Melgen trial by clicking here.

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Blinded by science: Women go blind after stem-cell treatment at Florida clinic - Palm Beach Post (blog)

Stem cell therapy could help mend the youngest of broken hearts – Medical Xpress

March 21, 2017 Credit: University of Bristol

Researchers have shown stem cells from the umbilical cord may hold the key to a new generation of graft and could reduce the number of surgeries required to treat young children born with certain types of congenital heart disease.

Congenital heart disease (CHD) is the most common type of birth defect. In the UK alone over 4,000 babies are diagnosed with CHD each year and thanks to advances in treatment and care, more than eight out of ten CHD babies grow up to be adults.

However, the only treatment for these conditions is corrective surgery where a piece of tissue, known as an implant, is used to replace the damaged area. Often surgery has to be repeated several times throughout childhood as the child's heart outgrows the artificial implant used to repair it.

Professors Massimo Caputo and Paolo Madeddu, in the Bristol Heart Institute, a newly created specialist research institute (SRI) at the University of Bristol, have developed cellular grafts using stem cells from the umbilical cord and placenta that are able to grow like living tissue and it is hoped would be able to grow along with a child's heart. These new grafts would mean that instead of having multiple operations to insert bigger grafts as the patient's heart grows only one operation would be needed.

These grafts have been tested in animal models that closely resemble the 'real-world' scenario and tested for their capacity to grow and regenerate the damaged heart. The researchers are also exploring which cells are best suited for the graft so that a wide range of treatment options and solutions could be tailored to the patients' needs. With the first two phases of research completed, the academics are now preparing to start a clinical trial in newborn babies.

Massimo Captuo, Professor of Congenital Heart Surgery from the School of Clinical Sciences, said: "We believe stem cells from the umbilical cord, usually discarded after birth, could hold the key to a new generation of graft. These grafts grow at the same rate as the children they're used to treat and reduce the risk of rejection after transplant as they contain the child's own DNA."

Paolo Madeddu, Professor of Experimental Cardiovascular Medicine from the School of Clinical Sciences, added: "The long-term outcomes for most young children remains poor and significantly affects their quality of life. By developing these new grafts, we hope to reduce the amount of surgeries that a child born with congenital heart disease must go through."

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Stem cell therapy could help mend the youngest of broken hearts - Medical Xpress

Stem cell therapy blinds 3 women in US – Tempo

SAN FRANCISCO (PNA/Xinhua) An ophthalmologist in the United States calls for increased patient education and regulation after three patients were blinded following a treatment marketed as a stem cell clinical trial.

A recent paper documenting the cases was co-authored by Jeffrey Goldberg, professor and chair of ophthalmology at the Stanford University School of Medicine, and published in The New England Journal of Medicine, a publication of the Massachusetts Medical Society as one of the most prestigious peer-reviewed medical journals in the world.

The three patients are all women, ranging in age from 72 to 88. They suffered from macular degeneration, a common, progressive disease of the retina that leads to loss of vision. Before the surgery, the vision in their eyes ranged from 20/30 to 20/200, meaning they can read at 20 feet, or about 6 meters, a letter that people with normal vision can read from 30 to 200 feet, or about 9 meters to 60 meters.

Now, the patients are likely to remain blind, said co-author Thomas Albini, an associate professor of clinical ophthalmology at the University of Miami, where two of the patients were treated for complications from the stem cell treatments.

Two of the patients learned of the so-called clinical trial on ClinicalTrials.gov, a registry and results database run by the U.S. National Library of Medicine, where it was called Study to assess the safety and effects of cells injected intravitreal in dry macular degeneration.

Each patient paid 5,000 U.S. dollars for the procedure. Any clinical trial that has a fee should raise a red flag, said the authors, with Albini adding Im not aware of any legitimate research, at least in ophthalmology, that is patient-funded.

At the clinic in Florida, which is not named in the paper, the patients had fat cells removed from their abdomens and a standard blood draw. The fat tissue was processed with enzymes, with the goal of obtaining stem cells. Platelet-dense plasma was isolated from the blood. The cells were then mixed with the platelet-dense plasma and injected into their eyes. Patients reported that the entire process took less than an hour, Albini said.

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Stem cell therapy blinds 3 women in US - Tempo

Stem cell therapy helps patients with osteoarthritis – Palm Beach Post – Palm Beach Post

New treatments and advances in research are giving new hope to people affected by Osteoarthritis pain and symptoms. Dr. Theofilos provides stem cell therapy for osteoarthritis to help those achieve better health and live life in motion.

Stem cell therapy for osteoarthritis is being studied for efficacy in improving the complications in patients through the use of their own stem cells. These procedures may help patients who dont respond to typical drug treatment, want to reduce their reliance on medication, or are looking to try stem cell therapy due to pain or discomfort.

Osteoarthritis, also known as degenerative arthritis or degenerative joint disease, is a group of mechanical abnormalities involving degradation of joints, including articular cartilage and subchondral bone. Symptoms may include joint pain, tenderness, stiffness, locking and sometimes an effusion. When bone surfaces become less well protected by cartilage, bone may be exposed and damaged. As a result of decreased movement secondary to pain, regional muscles may atrophy, and ligaments may be affected.

Stem cell treatment is designed to target these areas within the joints to help with the creation of new cartilage cells. Mesenchymal stem cells are multipotent and have the ability to differentiate into cartilage called (chondrytes). The goal of each stem cell treatment is to inject the stem cells into the joint to create cartilage.

Its expected that results of the therapy will vary depending upon the many factors of the severity, patients overall health, nutritional state and immune function. Stem cell therapy is safe and effective in reducing pain and improving function for many patients.

Voted as one of America's Top Surgeons, Charles S. Theofilos, MD, Neurosurgeon and Founder of The Spine Center is a leading provider of the state-of-the-art, most comfortable and effective surgical, minimally invasive and non-surgical treatment options for a full range of cervical and spinal ailments, including stem cell therapy and artificial disc replacement. He was among a field of 20 top neuro and orthopedic surgeons in the U.S. chosen to participate in the groundbreaking Artificial Disc Study, which compared the clinical outcome of disc replacement versus traditional spinal fusion. A widely sought after educator and lecturer, Dr. Theofilos has offices in Palm Beach Gardens and Port St. Lucie.

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Stem cell therapy helps patients with osteoarthritis - Palm Beach Post - Palm Beach Post

Three women blinded after Florida stem cell clinic injected fat cells into their eyes – New York Daily News

NEW YORK DAILY NEWS

Thursday, March 16, 2017, 2:21 PM

Three elderly women afraid of losing their vision were blinded after having their own fat and blood cells injected into their eyes at a Miami stem cell clinic.

The patients incorrectly believed the treatment was part of a federally monitored clinical trial, but in reality received an injection that hasnt been proven effective nor tested for safety in people, CBS News reported.

Each of them had working vision aside from some blurriness prior to the procedure. After though, one of the women was left completely blind while the other two are now legally blind.

It seems unlikely their vision will improve, said ophthalmologist Dr. Thomas Albini, who examined the patients following their treatment. He and his colleagues described the outcome of the procedure in Thursdays New England Journal of Medicine.

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The group of women, in their 70s and 80s, in 2015 paid $5,000 to be treated for age-related macular degeneration one of the top causes of vision loss in people over the age of 50. At least two of the women showed up at the clinic because it specifically listed a macular degeneration study on a federal database, a listing the clinic later withdrew.

The consent form one woman showed Albini listed the treatment as a medical procedure rather than a study, the ophthalmologist told CBS.

Each of the patients were reportedly injected in both eyes with a mixture of cells derived from their own fat tissue.

Its very alarming to us as clinicians that somebody would do this to both eyes at the same time, Albini said, adding all three women suffered from detached retinas.

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Scientists have long studied similar procedures including taking stem cells from a patients body as a cure for vision problems, among other ailments and diseases.

Medical professionals and scientists have issued strong warnings against clinics doling out unproven stem cell treatments. Because these clinicians use the patients own stem cells, theyre minimally regulated by the Food and Drug Administration.

This report joins a small but growing medical literature highlighting the risks of such wanton misapplication of cellular therapy, stem cell expert Dr. George Daley wrote in an editorial accompanying a report on the procedure in question.

An attorney who represented two of the three women in lawsuits regarding the treatment said both cases have been resolved, but did not provide additional details.

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Three women blinded after Florida stem cell clinic injected fat cells into their eyes - New York Daily News

Three People Are Nearly Blind After Getting a Stem Cell Treatment – TIME

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When doctors give their patients a difficult diagnosis, whether its for a condition like cancer or a rarer disease for which there is no standard treatment, they often refer them to clinicaltrials.gov . The National Institutes of Health and National Library of Medicine provide this web site as a service for people who want to find and participate in trials of experimental treatments. With so many new studies launched every day of promising therapies, it is a helpful resource for both doctors and patients eager to do everything they can to beat their disease.

But a report published in the New England Journal of Medicine highlights the dangers of some experimental trials, even ones listed on a government-supported site. Three women in their 70s and 80s who enrolled in a stem cell trial to treat age-related macular degeneration , caused by deterioration of the most sensitive part of the retina, were left with severe vision loss following the treatment they received in the trial. All three patients found the study, sponsored by BioHeart, Inc., on clinicaltrials.gov.

The women each had liposuction to remove fat tissue, and the fat cells were processed to extract stem cells that they were told would develop into cells that would replace the diseased ones in their eyes.

Instead, the injected solution caused inflammation, infection and detached retinas in all three women. Detached retinas require surgery to repair in order to prevent blindness. Within days of receiving the treatment, all three patients went to the hospital with vision loss, severe infections and bleeding.

BioHeart, now known as U.S. Stem Cell, issued the following statement on the results. We are unable to comment further on specific cases due to patient confidentiality or legal confidentiality obligations. Neither U.S. Stem Cell nor U.S. Stem Cell Clinic currently treats eye patients.

The study was conducted in several unusual ways, says Dr. Thomas Albini, from the Bascom Palmer Eye Institute, who was not involved in the trial but treated two of the women after they developed complications. First, all three women had both eyes treated at the same time, which Albini says isn't typical for an untested therapy. When testing something experimental for the eye, doctors usually treat only one eye at a time, in case adverse events occur or the treatment proves too dangerous or toxic to the patient.

He says that the patients only signed what appears to be a one-page surgical consent form for the procedure. The form may have indicated that the procedure they would receive was experimental and had not been approved, but clinical trial consent forms are usually lengthy documents that detail the procedure and the risks and potential benefits involved. The two women told Albini that they did not recall signing documents other than the single page form.

The patients also learned that the trial was being funded by payments they and others made. Each patient who enrolled paid $5,000 to receive the experimental treatment in both eyes, according to the women. The vast majority of legitimate clinical trials do not require payment. In fact, most tests and therapieseven transportation to the facility, in some casesare generally covered by the study.

The unfortunate outcome is a reminder of the burden put on patients to vet trials, even if they appear on clinicaltrials.gov. That may be challenging for people without any medical background, especially since clinicaltrials.gov is maintained by what most believe to be reliable and ethical government health institutes. But the site doesn't vet every trial posted; it performs minimal review of study designs to ensure they are scientifically sound and have received ethical and scientific approval from what are called institutional review boards (IRBs). These boards include both scientific experts as well as ethicists to analyze a study to make sure participants won't be exploited. Without mandatory requirements for such board approvals, any investigator can technically post a trial on the site. And while the Food and Drug Administration (FDA) approves drugs and medical treatments, it doesnt have direct oversight over clinicaltrials.gov. Patients confuse FDA approval of a treatment, which does indicate that a treatment has met certain standards like it has demonstrated efficacy and safety, with just being listed on the web site, says Albini.

The site does state that ClinicalTrials.gov does not independently verify the scientific validity or relevant of the submitted information beyond a limited quality control review for apparent errors, deficiencies or inconsistencies. But, Albini says, the web site could probably do a better job of making that disclaimer more prominent.

Albini says the incident should reinforce to doctors that simply sending their patients to clinicaltrials.gov isnt enough. Patients need help from the medical community or public health officials to navigate sites like these and make sense of the information they find, he says.

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Three People Are Nearly Blind After Getting a Stem Cell Treatment - TIME