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Stem-Cell Therapy Clinics Remain Inadequately Regulated, Pose Risk to Patients

Though the U.S. Food & Drug Administration (FDA) is more tightly regulating U.S. clinics that tout stem-cell trials and treatments for inherited retinal diseases (IRDs) and a host of other conditions, many significant loopholes and enforcement limitations remain.

The bottom line is: The FDA has not yet established regulations to adequately protect patients with IRDs seeking treatments from these clinics. If a clinic is charging for a stem-cell treatment or procedure for an IRD, it is probably not legit. The expense to the patient is a major red flag.

There are currently no FDA-approved stem-cell-derived therapies for IRDs, and clinical trials for any emerging treatments should not be charging for the therapy or the procedure. (Travel and lodging are the only expenses one might incur as a trial participant.)

Also, just because a so-called trial is listed on www.clinicaltrials.gov doesn’t mean it is regulated by the FDA. The website doesn’t prevent unregulated trials and treatments from being posted.

If you have any questions about the legitimacy of a stem-cell clinic, trial, or alleged therapy, contact the Foundation Fighting Blindness at info@fightblindness.org.

While newly announced FDA regulations are a step in the right direction, they still fall short in protecting patients. For example:

  • The FDA has acknowledged that it doesn’t have the resources to broadly enforce its new regulations.
  • The FDA is giving clinics three years to comply with its new rules.
  • The FDA lacks clarity in regulations for certain types of cells used by some of the clinics (e.g., bone-marrow stem cells obtained from the patient), which may leave open loopholes.

If you are wondering what types of safety risks are associated with these clinics and their alleged treatments, check out our blog post from March 16, 2017: Unregulated Stem-Cell Therapy Causes Severe Vision Loss for Three Florida Women.

Keep in mind that many of these clinics also operate overseas, where regulations are minimal or nonexistent.

Again, if you have any questions, please contact the Foundation at info@fightblindness.org.


2 Responses to 'Stem-Cell Therapy Clinics Remain Inadequately Regulated, Pose Risk to Patients'

  1. Eunice says:

    Hello Dr. Rose,

    I have been reading a lot of journals and/or literature about stem cell therapy for MD disease. However, I was wondering, recently my son got injured in his left eye by a rubber band (bungee rope) that he was pulling with his sister and regretfully, it split into two and hit him directly on the eye, leaving him with serious eye trauma, but his retina did not detach. It has been about 60 days now, and his visual acuity is about 20/500, and he says he can see a little on the side of his eye. His doctor, a retina specialist who saw him and continues to see him says part of his macula is probably damaged (she has used terms like macula atrophy, macula whitening, macula scarring, e.t.c, e.t.c that will likely limit vision), and so far the doctor has not been able to give a conclusive prognosis, but I guess it is possible that his central vision is severely damaged from the trauma? He had an operation 2 days after the accident, and the surgeon said she only did a 360 exploration for s/p open globe, but of since there was to retinal tear/detachment, she simply closed it up and she says there is no need for any further surgery at this time. My question is, what really happened to his macula? I have read a lot about photo receptors, and I guess I want to know if in the future, once stem cell treatment to the macula is successful on humans, can he benefit from the treatment given that he does not have macular degeneration disease, rather his situation is from blunt trauma that has possibly damaged his macula and ability to see/read because of central vision being damaged? He is only 7 years old, and I will make it my life mission to get him the help he needs to be able to recover and enjoy doing what he loves to do. He is just a strong boy who loves to exercise, run, play basketball, and he even wants to be a professional wrestler some day. Any advice and suggestions to help me help him will be greatly appreciated. As a mother, I feel like there is still hope for him somehow through science and through prayer. Please help!!!

    • EyeOnTheCure says:

      Our mission is directed at inherited retinal diseases. It is difficult for us to speculate whether a future stem-cell treatment will help your son. You may consider going to an academic research center for evaluation. Best of luck!

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