Three people left blind by Florida clinic’s unproven stem cell therapy

Unproven treatment

Unproven stem cell treatments endanger patients: Photo courtesy Healthline

The report makes for chilling reading. Three women, all suffering from macular degeneration – the leading cause of vision loss in the US – went to a Florida clinic hoping that a stem cell therapy would save their eyesight. Instead, it caused all three to go blind.

The study, in the latest issue of the New England Journal of Medicine, is a warning to all patients about the dangers of getting unproven, unapproved stem cell therapies.

In this case, the clinic took fat and blood from the patient, put the samples through a centrifuge to concentrate the stem cells, mixed them together and then injected them into the back of the woman’s eyes. In each case they injected this mixture into both eyes.

Irreparable harm

Within days the women, who ranged in age from 72 to 88, began to experience severe side effects including bleeding in the eye, detached retinas, and vision loss. The women got expert treatment at specialist eye centers to try and undo the damage done by the clinic, but it was too late. They are now blind with little hope for regaining their eyesight.

In a news release Thomas Alibini, one of the lead authors of the study, says clinics like this prey on vulnerable people:

“There’s a lot of hope for stem cells, and these types of clinics appeal to patients desperate for care who hope that stem cells are going to be the answer, but in this case these women participated in a clinical enterprise that was off-the-charts dangerous.”

Warning signs

So what went wrong? The researchers say this clinic’s approach raised a number of “red flags”:

  • First there is almost no evidence that the fat/blood stem cell combination the clinic used could help repair the photoreceptor cells in the eye that are attacked in macular degeneration.
  • The clinic charged the women $5,000 for the procedure. Usually in FDA-approved trials the clinical trial sponsor will cover the cost of the therapy being tested.
  • Both eyes were injected at the same time. Most clinical trials would only treat one eye at a time and allow up to 30 days between patients to ensure the approach was safe.
  • Even though the treatment was listed on the clinicaltrials.gov website there is no evidence that this was part of a clinical trial, and certainly not one approved by the Food and Drug Administration (FDA) which regulates stem cell therapies.

As CIRM’s Abla Creasey told the San Francisco Chronicle’s Erin Allday, there is little evidence these fat stem cells are effective, or even safe, for eye conditions.

“There’s no doubt there are some stem cells in fat. As to whether they are the right cells to be put into the eye, that’s a different question. The misuse of stem cells in the wrong locations, using the wrong stem cells, is going to lead to bad outcomes.”

The study points out that not all projects listed on the Clinicaltrials.gov site are checked to make sure they are scientifically sound and have done the preclinical testing needed to reduce the likelihood they may endanger patients.

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Jeffrey Goldberg

Jeffrey Goldberg, a professor of Ophthalmology at Stanford and the co-author of the study, says this is a warning to all patients considering unproven stem cell therapies:

“There is a lot of very well-founded evidence for the positive potential of stem therapy for many human diseases, but there’s no excuse for not designing a trial properly and basing it on preclinical research.”

There are a number of resources available to people considering being part of a clinical trial including CIRM’s “So You Want to Participate in a Clinical Trial”  and the  website A Closer Look at Stem Cells , which is sponsored by the International Society for Stem Cell Research (ISSCR).

CIRM is currently funding two clinical trials aimed at helping people with vision loss. One is Dr. Mark Humayun’s research on macular degeneration – the same disease these women had – and the other is Dr. Henry Klassen’s research into retinitis pigmentosa. Both these projects have been approved by the FDA showing they have done all the testing required to try and ensure they are safe in people.

In the past this blog has been a vocal critic of the FDA and the lengthy and cumbersome approval process for stem cell clinical trials. We have, and still do, advocate for a more efficient process. But this study is a powerful reminder that we need safeguards to protect patients, that any therapy being tested in people needs to have undergone rigorous testing to reduce the likelihood it may endanger them.

These three women paid $5,000 for their treatment. But the final cost was far greater. We never want to see that happen to anyone ever again.

TV’s Dr. Oz takes on clinics offering dubious stem cell treatments

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A. J. Foyt: Photo courtesy Indycar.com

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At first glance motor car racing legend A. J. Foyt and TV celebrity heart surgeon Dr. Mehmet Oz would seem to have little in common. But this week they both made news for being at opposite ends of an all too familiar story: for-profit medical clinics offering unproven stem cell therapies.

Foyt, who is now 82 years old, made history by becoming the only driver to win the Indianapolis 500 (4 times), the Daytona 500, the 24 Hours of Daytona, and the 24 Hours of Le Mans. But along the way he crashed several times leading to a broken back, broken feet and legs and numerous other injuries. Now, in a story in USA Today he announced he is going to Mexico to get a stem cell treatment to help repair his battered body.

In the article he is quoted talking about the procedure to IndyCar.com:

“They have to cut away some of the tissue from my stomach and it takes 8-10 weeks for it to grow back to produce the stem cells. I’ll probably have it done soon so that we can begin the treatment within the next two to three months.”

He then plans on having those stem cells, taken from fat in his stomach, injected into his ankles, shoulders and blood.

Now, that doesn’t sound like any stem cell therapy I have ever heard of and ordinarily we’d blog about the risks involved in going to a clinic like this for a “treatment” like this. But this week we don’t have to, because Dr. Oz did it for us.

This week the Dr. Oz TV show ran a special investigative story that looked at for-profit stem cell clinics that offer ”treatments” for everything from arthritis to Alzheimer’s, using the same cells and the same approach.

In an accompanying blog called ‘Crucial Tips to Avoid Stem Cell Scammers’ Elizabeth Leamy – who took part in undercover visits to several clinics – says there are more than 570 clinics around the US offering unproven and unapproved treatments:

“What I learned is that revenue has eclipsed research. Hundreds of for-profit stem cell clinics already exist across the country because desperate patients will pay big money —$5,000 to $20,000 a pop— for stem cell treatments. Surely it’s no coincidence that the patients these clinics target are those with diseases for which there is no known cure.”

The blog does a terrific job of exposing the tricks that clinics use to get patients to sign up for these “treatments” and highlights key red flags for people to watch out for:

  • Be wary of clinics that offer treatments with stem cells that originate from a part of the body that is different from the part being treated.
  • Watch out for clinics where treatments are offered for a wide variety of conditions but rely on a single cell type.
  • Be wary of clinics that measure or advertise their results primarily through patient testimonials.
  • Be wary of claims that stem cells will somehow just know where to go and what to do to treat a specific condition.

She concludes by warning that “just because stem cells came from your body doesn’t mean they are safe,” then listing the complications, even deaths, that have occurred among patients going to clinics like this, both inside and outside the US, saying:

“Yes, what we heard in our undercover visits was troubling. But worst yet, the premature stem cell treatments of today could undermine trust in the promising stem cell treatments of tomorrow.”

Perhaps someone should tell A. J. Foyt.