Listen to this page using ReadSpeaker

Unregulated Stem-Cell Therapy Causes Severe Vision Loss for Three Florida Women

A report today in The New England Journal of Medicine (NEJM) describes the cases of three women with age-related macular degeneration (AMD) who lost much of their eyesight after receiving ocular injections of stem cells derived from their own fat tissue. All of the women had good enough eyesight to drive before the procedures. Each paid $5,000 to receive the injections from a private clinic in Sunrise, Florida. The New York Times and other major media outlets have published news stories on the NEJM report.

The administration of the stem cells was performed without oversight from the U.S. Food and Drug Administration (FDA), because, the clinic claims, the cells were the patients’ own — the tissue was extracted from the patients’ bellies. However, the patients said they believed they were participating in government-regulated trials, because the study was listed on www.clinicaltrials.gov, a website maintained by the National Institutes of Health. What’s important for the public to know is that the website listing does not mean that the procedure is approved by the NIH and has undergone FDA review and authorization.

In an accompanying NEJM article, scientists from the FDA say the fat-derived stem cells, “are being used in practice on the basis of minimal clinical evidence of safety or efficacy sometimes with the claims that they constitute revolutionary treatments.”

“The tragedy for these three women, and others who opt for these unproven, unregulated treatments, is they don’t understand the risks and lack of evidence for efficacy,” says Stephen Rose, PhD, chief research officer, Foundation Fighting Blindness, the world’s leading private funder of research for inherited retinal diseases. “As seen in this case and others reported in the literature and press, participation in a study for an emerging therapy that is not regulated by the FDA or another well-recognized regulatory agency like the European Medicines Agency in Europe, is fraught with dangers and can lead to unexpected serious consequences.”

Dr. Rose says that the Foundation regularly receives inquiries from people who are inquiring about unregulated stem-cell trials in the United States and around the world. Some of the alleged therapies cost tens of thousands of dollars. “Understandably, people are anxious to do whatever they can to save their vision from retinal diseases like retinitis pigmentosa and AMD,” says Dr. Rose. “Unfortunately, there are many unregulated ‘trials’ that are taking advantage of the desperation associated with loss of vision, and peoples’ vision and lives are at risk. Patients participating in legitimate clinical trials of potential treatments do not typically incur any treatment fees.  A fee associated with participation in a clinical study may be a red flag.  Anyone contemplating participating in any clinical trial should consult their ophthalmologist or physician first.”

FDA-regulated clinical trials for emerging stem-cell-derived therapies for AMD and RP are underway in the United States. Most of these studies are at an early stage and primarily evaluating safety. For more information on these studies, contact the Foundation at info@fightblindness.org  or visit www.fightblindness.org.


6 Responses to 'Unregulated Stem-Cell Therapy Causes Severe Vision Loss for Three Florida Women'

  1. Alice says:

    I just found out that I have started going blind in my left eye from Macula Degeneration. Of course I’m trying to find out what I can while I still can see. I found this Wed site. So I have looked at it. Really I am trying to find a specific Doctor who can treat me. So far I have not found one. Thank you Alice

    • Dr. Tim Schoen says:

      Dear Alice, Please call the Foundation Fighting Blindness at 800-683-5555 and ask for information on doctors in your geographic area.

    • cj gehring says:

      please come join our SRARGARDTS DISEASE-MACULAR DEGENERATION SUPPORT GROUP, OF ALMOST 3,000 PEOPLE FROM AROUND THE WORLD. YOU CAN FIND US ON FB. PLEASE JOIN US. WHERE ARE YOU FROM? ONE OF US WILL HAVE A SUGGESTION FOR YOU & YOU WILL FIND MANY ANSWERS ON OUR GROUP PAGE. IN THE MEANTIME, NO VIAMIN A, LIMIT FOODS HIGHEST IN BETA CAROTENE, AND WEAR SUNGLASSES THAT HAVE BEEN TREATED TO BLOCK ALL UVA, UVB, AND BLUE RAYS…CATHRYN (MOTHER IN SUPPORT GROUP)

    • Dolores says:

      I have been having monthly Eyler shots since nov 16 and have gotten my full eyesight regained. I

  2. cj gehring says:

    ALICE…I RESPONDED BUT DON’T SEE IT POSTED, SO…PLEASE GO TO FACE BOOK AND JOIN OUR STARGARDTS DISEASE-MACULAR DEGENERATION SUPPORT GROUP. YOU WILL FIND MANY ANSWERS TO YOUR QUESTIONS…CATHRYN

  3. Erick says:

    I had someone call me out of the blue asking about stem cells for heart failure. So i googled Texas Heart and CCF (two biggest cardiac centers) and sure they have trials for cardiac stem cells but nothing recognized, validated or approved for commercial use.

    I have a buddy who works for a stem cell company and they have gone through $300m+ and still get so-so clinical trials results for pancreatic cells. My guess is that this joint stuff is voodoo science mostly for making a buck off desperate people.

Leave a Reply

Your email address will not be published. Required fields are marked *

*