Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings
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Stem cells hold tremendous potential to advance health and medicine. Through replacement of damaged cells and organs or supporting intrinsic repair, stem cell offer promising treatments for debilitating diseases and conditions such as Parkinson’s disease, diabetes, and spinal cord injury. Currently, however, the evidence base to support the medical use of stem cells is still limited, with few clinical applications shown to be safe and effective. Despite the preliminary nature of clinical evidence, consumer demand for treatments using stem cells has risen, fueled by direct-to-consumer advertising of stem cell-based treatments. Clinics have been established throughout the world, both in newly industrialized nations such as China, India, and Mexico, as well as developed countries such as the United States and within Europe, that offer "stem cell therapies" for a wide range of diseases and conditions. Often provided at great expense and often promoted as established and effective, these treatments have generally not received stringent regulatory oversight, have not been tested through rigorous trials to determine safety and likely benefit, and the claims remain largely unsubstantiated by medical science. Complications from treatments have ranged from tumor formation to the death of patients. Some feel that the false claims and potential for harm to patients could significantly damage the real potential of research to produce valid stem cell therapies.
The Institute of Medicine and the National Academy of Sciences will co-host a workshop with the International Society for Stem Cell Research that will take a critical look at the practice of unproven stem cell treatments. Speakers will examine the evidence base of unsubstantiated treatment offerings and the associated research and clinical risks and concerns. Discussions will delve into legal hurdles for establishing standards and criteria to govern stem cell trials and treatments and explore a range of potential solutions for assuring the quality of unregulated therapies.