This week, the nominee to head the FDA was grilled on Capitol Hill about plans to go after the sale of unregulated stem cell therapies in the U.S. 

Physicians and patients are both warned to be vigilant in this new territory of stem cell treatments. Patients are warned to have realistic expectations, understand the risks and potential benefits. Practitioners are being told to expect crack downs on unregulated stem cell uses, deceptive advertising making promises, offering cures, or otherwise making false claims. 

Stem cells are very young cells that have potential to develop into specialized cells in multiple organs and systems of the body. Right now, stem cells are approved by the US Food and Drug Administration to treat only two medical conditions: blood and immune disorders. But that has not stopped experimentation into hundreds of potential applications, and sale of unregulated stem cell therapies to consumers that have, in some cases, caused devastating results. 

From 2014-2019, the number of U.S. stem cell clinics rose from 90 to over 700. Most are selling very expensive, unregulated therapies for treatments of conditions and diseases that are not FDA approved. The FDA says there is not enough information yet to declare these unregulated treatments either safe or effective. 

Recently, Google stopped a proliferation of ads selling stem cell therapies that claimed to treat diseases for which there is no cure, including macular degeneration. At a stem cell clinic in Georgia, a woman seeking a cure from this eye disease was injected in the eye with stem cells drawn from her own abdominal fat cells. Four months later, she was blind. The Federal Trade Commission is also looking into the advertising claims made by stem cell clinics, promising results from unproven therapies, and misrepresenting the safety concerns. 

Stem cell therapy shows early promise for many new applications in research labs, including orthopedic applications. But stem cell therapies as they are currently marketed remain largely unproven, unregulated, and hugely expensive. Health insurance will not cover the costs. The risks, even when patients donate their own stem cells to these treatments, include: administration site reactions, movement and mal-development of the cells into unwanted locations and formations, growth of tumors, and overall failure of the treatment to work.