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Cell-based therapies (CBTs) have been hailed for the last two decades as the next pillar of healthcare, yet the clinical and commercial potential of regenerative medicine has yet to live up to the hype. While recent analysis has suggested that regenerative medicine is maturing into a multibillion dollar industry, examples of clinical and commercial success are still relatively rare. With 30 years of laboratory and clinical efforts fueled by countless billions in public and private funding, one must contemplate why CBTs have not made a greater impact. The current regulatory environment, with its zero-risk stance, stymies clinical innovation while fueling a potentially risky medical tourism industry. Here, we highlight the challenges the US FDA faces and present talking points for an improved regulatory framework for autologous CBTs.

Promising new medical technologies and approaches to treatment offer the potential to substantially improve the lives of patients who need help, and in some cases transform the way medicine is practiced. In recent years, the biotechnology industry has generated many examples of new approaches that are having a profound impact on medical care, including protein and peptide therapeutics, monoclonal antibodies and molecular diagnostics.