Regenerative Medicine Build-Out

Abstract

Regenerative technologies strive to boost innate repair processes and restitute normative impact. Deployment of regenerative principles into practice is poised to usher in a new era in health care, driving radical innovation in patient management to address the needs of an aging population challenged by escalating chronic diseases. There is urgency to design, execute, and validate viable paradigms for translating and implementing the science of regenerative medicine into tangible health benefits that provide value to stakeholders. A regenerative medicine model of care would entail scalable production and standardized application of clinical grade biotherapies supported by comprehensive supply chain capabilities that integrate sourcing and manufacturing with care delivery. Mayo Clinic has rolled out a blueprint for discovery, translation, and application of regenerative medicine therapies for accelerated adoption into the standard of care. To establish regenerative medical and surgical service lines, the Mayo Clinic model incorporates patient access, enabling platforms and delivery. Access is coordinated through a designated portal, the Regenerative Medicine Consult Service, serving to facilitate patient/provider education, procurement of biomaterials, referral to specialty services, and/or regenerative interventions, often in clinical trials. Platforms include the Regenerative Medicine Biotrust and Good Manufacturing Practice facilities for manufacture of clinical grade products for cell-based, acellular, and/or biomaterial applications. Care delivery leverages dedicated interventional suites for provision of regenerative services. Performance is tracked using a scorecard system to inform decision making. The Mayo Clinic roadmap exemplifies an integrated organization in the discovery, development, and delivery of regenerative medicine within a growing community of practice at the core of modern health care.

Significance: Regenerative medicine is at the vanguard of health care poised to offer solutions for many of today's incurable diseases. Accordingly, there is a pressing need to develop, deploy, and demonstrate a viable framework for rollout of a regenerative medicine model of care. Translation of regenerative medicine principles into practice is feasible, yet clinical validity and utility must be established to ensure approval and adoption. Standardized and scaled-up regenerative products and services across medical and surgical specialties must in turn achieve a value-added proposition, advancing intended outcome beyond current management strategies.

Figure 1.

Regenerative medicine blueprint catalyzed by the Mayo Clinic Center for Regenerative Medicine. Powered by advances in fundamental sciences and responding to the unmet patient needs across clinical specialties, the Mayo Clinic regenerative medicine service line build-out incorporates dedicated patient access, enabling technology platforms and multispecialty delivery. Regenerative Medicine Portals refer to a Regenerative Medicine Consult Service (or alternate specialty services) coordinating patient access. Regenerative Medicine Platforms refer to integrated collection, preservation, processing, quality assurance, manufacture, and release of clinical-grade regenerative cellular, acellular, and biomaterial products. Regenerative Medicine Procedures refer to delivery of regenerative therapies across medical and surgical specialties.

Figure 2.

Overview of clinical trials sponsored by the Mayo Clinic Center for Regenerative Medicine. The spectrum of clinical trial categories underscores the multidisciplinary nature of the enterprise-wide endeavor engaging medical, surgical, and laboratory medicine specialties. Abbreviations: GI, gastrointestinal; iPS, induced pluripotent stem; POP, pelvic organ prolapse.