Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings Workshop
The workshop on Stem Cell Therapies: Opportunities for Assuring the Quality and Safety of Unregulated Clinical Offerings was held on November 18, from 8:30am to 5:30pm, in Room 125 at the National Academy of Sciences Building at 2101 Constitution Avenue, NW, Washington, DC.
Stem cells hold tremendous potential to advance health and medicine. Through replacement of damaged cells and organs or supporting intrinsic repair, stem cells hold the potential to be used in the treatment of 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. These treatments have generally not received stringent regulatory oversight and have not been tested through rigorous trials to determine safety and likely benefit, though they are often promoted as being established and effective. In the absence of substantiated claims, some feel that the potential for harm to patients as well as the field of stem cell research outweighs the potential benefits.
This workshop will take a critical look at the current environment in which patients are receiving unregulated stem cells treatments. Speakers will examine the stem cell treatments that are being offered, the potential benefits and risks to individual health, the evidence base needed to substantiate the clinical application of stem cell technologies, and legal hurdles for establishing standards and criteria to govern stem cell trials and treatments. Potential solutions for assuring the quality of stem cell therapies will also be examined.