Preparing Regenerative Therapies for Clinical Application: Proposals for Responsible Translation

The document from 2019 discusses the growth of regenerative medicine and the challenges in translating these therapies to clinical practice. It outlines the FDA's role in balancing innovation with patient safety and the 21st Century Cures Act's impact on speeding up the market introduction of regenerative therapies. The Mayo Clinic's Regenerative Therapeutics Program is highlighted as a model for delivering regenerative care, featuring patient education services, compliant cell therapy procedures, and the Regenerative Evidence-Based Outcomes Registry (REBO) to collect real-world evidence. Despite clinical trial successes and FDA approvals for certain conditions, many therapies lack strong evidence and are not yet standard practice. The document calls for a multidisciplinary collaborative approach, more high-quality evidence, and a framework for responsible translation that includes scientific, ethical, and quality control considerations to ensure patient safety and effective innovation.