Avoid unlicensed clinics offering unapproved stem cell therapy

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By Dr. Mark S. Siegel

Stem cell therapies are getting headlines for their potential to cure diseases, including those that affect vision. But an important message is missing: the therapies are not yet proven to be safe and effective for your eyes.

Stem cell treatments appear to offer hope to people with few options to recover vision. This includes people with forms of age-related macular degeneration (AMD), retinitis pigmentosa (RP) and Stargardt disease. 

Some clinics across the United States offer “stem cell therapy” to people outside of clinical trials. But the U.S. Food and Drug Administration (FDA) has not approved the treatments they offer. These treatments often use unproven products that may be ineffective or dangerous. These products may carry serious risks, including tumor growth.

Questions to ask

It is important that you know that there are no stem cell products approved by the FDA for eye disease right now. 

If you want stem cell therapy, look for a clinical trial and discuss the matter with your ophthalmologist. A clinic should not expect you to pay thousands of dollars for an unproven, unapproved therapy. Your health insurance will not cover the cost of an unapproved treatment.

Before agreeing to a stem cell treatment, ask:

• Is the stem cell treatment approved by the FDA?

• Is the stem cell treatment part of an FDA-approved clinical trial?

• Is the stem cell treatment covered by your health insurance?

It is frustrating and frightening to face the loss of vision while waiting for potential treatments. However, choosing to pursue an unproven treatment in an unlicensed clinic is an unacceptable risk to your vision and your overall health.

Dr. Mark S. Siegel is the medical director at Sea Island Ophthalmology on Ribaut Road. Visit www.seaislandophthalmology.com.

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