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Tue, Nov 28 11:51am

Understanding FDA approved or allowed stem cell therapies

By Suzanne Ferguson, @suzannerferguson

stemcell

The Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome (HLHS) is running clinical trials using stem cells derived from the individuals themselves (called autologous stem cells).  All of the clinical trials are being studied in accordance with the U.S. Food and Drug Administration (FDA).

What are stem cell therapies? According to the FDA, they “may offer the potential to treat diseases or conditions for which few treatments exist.” Stem cells are derived from the body including being taken from cord blood, bone marrow and fat tissue.

Our HLHS program has two FDA monitored clinical trials using stem cells – one clinical trial uses stem cells derived from an individual’s own cord blood) and the second uses stem cells derived from an individual’s own bone marrow . The purpose of these clinical trials is to possibly strengthen the single, functioning right ventricle in patients with HLHS. Before enrolling patients into the clinical trials, both trials were submitted to the FDA for a review process in order to determine the safety and efficacy of using the stem cells in controlled settings. Once the clinical trials are complete, the results will be published and made available for public review.

When looking into stem cell therapies, make sure the therapies have been either approved or allowed by the FDA as they are the regulatory authority for all therapeutic modalities in the U.S.

Read more about the FDA’s stem cell safety statement on their website.


The Todd and Karen Wanek Family Program for Hypoplastic Left Heart Syndrome (HLHS) is a collaborative network of specialists bonded by the vision of delaying or preventing heart failure for individuals affected by congenital heart defects including HLHS. The specialized team is addressing the various aspects of these defects by using research and clinical strategies ranging from basic science to diagnostic imaging to regenerative therapies.

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