Cynata Therapeutics said neither of its pivotal Cymerus stem cell platform trials met primary endpoints in osteoarthritis and graft-versus-host disease (GVHD). CEO Kilian Kelly told investors the active and control groups did not show statistically significant differences on primary or key secondary efficacy measures. The result stops progress toward the intended registrational pathway and raises questions about Cymerus’ next clinical development direction. Cynata will now need to reassess trial design and target populations in order to continue development given the lack of endpoint separation. The update arrives as the stem-cell platform field faces heightened scrutiny on clinical robustness and scalability of manufacturing and clinical claims.