Stem Cell Therapies: Opportunities for Ensuring the Quality and Safety of Clinical Offerings - Summary of a Joint Workshop


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Stem cells offer tremendous promise for advancing health and medicine. Whether being used to replace damaged cells and organs or supporting the body’s intrinsic repair mechanisms, stem cells hold potential to treat such debilitating conditions as Parkinson’s disease, diabetes, and spinal cord injury. Though clinical trials of stem cell treatments are underway around the world, the evidence base to support the medical use of stem cells remains limited.

Despite the lack of clinical evidence, consumer demand for treatments using stem cells has risen, driven in part by a lack of available treatment options for debilitating diseases as well as direct-to-consumer advertising and public portrayals of stem cell-based treatments. Therapies offered at clinics around the world generally have not received stringent regulatory oversight and have not been tested with rigorous trials.

On November 18, 2013, the IOM, the National Academy of Sciences, and the International Society for Stem Cell Research held a workshop to examine the global pattern of treatments and products being offered, the range of patient experiences, and options to maximize the well-being of patients, either by protecting them from dangerous or ineffective treatments or by steering them towards effective treatments. This document summarizes the workshop.

For additional resources, such as the agenda and presentations, please visit the workshop page.