Priority research needs include large-scale randomized controlled trials to establish efficacy and safety, dose-ranging studies to optimize treatment protocols, long-term safety studies particularly regarding cancer risk, and comparative effectiveness research with established therapies
They are not intended to diagnose, treat, cure, or prevent any disease or medical condition.
Primary endpoints should center on pain and function Knee Injury and Osteoarthritis Outcome Score (KOOS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Patient-Reported Outcome Measurement Information System (PROMIS) scores), structure (MRI evaluation with delayed gadolinium-enhanced MRI of cartilage (dGEMRIC) when appropriate), and time to milestones (return to sport)
BPC-157 is often framed around repair and blood flow, while KPV is framed around immune signaling