Regulatory and Ethical Aspects of Orthobiologic Therapies

Microfat - Orthopedics

November 30, 2022

Sage Journals/Murray, Biologics Association, The Orthopaedic Journal of Sports Medicine

Iain R. Murray, MFSEM, FRCS (Tr&Orth), PhD, Jorge Chahla, MD, PhD, Sarah J. Wordie, MBChB, Shane A. Shapiro, MD, Nicolas S. Piuzzi, MD, Rachel M. Frank, MD, Joanne Halbrecht, MD, Kiyoshi Okada, MD, PhD, Norimasa Nakamura, MD, Bert Mandelbaum, MD, Jason L. Dragoo, MD

Orthobiologics show significant promise in improving outcomes for patients with a wide variety of musculoskeletal pathologies. There is considerable worldwide variation in the regulatory pathways that must be followed. Navigating these complex pathways is challenging for both scientists and clinicians. Understanding the regulatory pathways as well as the logistical and ethical factors involved in the clinical translation of orthobiologic therapies will better equip clinicians as they seek to offer their patients the best chance of recovery while keeping them safe.