Regulated, reliable, and reputable: Protect patients with uniform standards for stem cell treatments

• Published in: Stem cells translational medicine 2020-05, Vol.9 (5), p.547-553
• Main Authors: Lomax, Geoffrey P., Torres, Art, Millan, Maria T.
• Format: Article
• Language: English
• Subjects: clinical trials; ethics; Evidence-based medicine; FDA approval; Federal regulation; Gene therapy; Manufacturing; Medical societies; Patient safety; Regenerative medicine; Stem cell research; stem cell transplantation; Stem cells
• ISSN: 2157-6564; 2157-6580; 2157-6580
• DOI: 10.1002/sctm.19-0377

The promise of cell and gene therapies is being realized as new products emerge to treat diseases once considered intractable. These treatments are emerging amidst reports of patients being injured by unproven “stem cell” interventions. At this juncture, it is vital to be supporting the continued development of promising regenerative medicine products while protecting patients from the risks posed by unproven interventions. Various stakeholders, including governments, patient groups, medical societies, and the media, are committed to this outcome. In this perspective, we draw on our experience gained from partnerships in developing regenerative medicine products to identify technical, organizational, and ethical benchmarks for the responsible delivery of regenerative medicine treatments. These benchmarks may serve as the basis for policy interventions intended to drive the responsible delivery of stem cell and regenerative medicine products. Our particular focus is on a California‐based policy, but the suggested benchmarks are broadly applicable to national and international jurisdictions.