The TREASURE trial, a phase 2/3 study, evaluated the bone marrow-derived cell therapy HLCM051 in 206 acute ischemic stroke (AIS) patients. Patients were randomly assigned to receive either HLCM051 or a placebo shortly after stroke onset. The trial found no significant improvement in outcomes at 90 days between the HLCM051 and placebo groups; however, exploratory analyses suggested potential benefits for patients with smaller ischemic core volumes or those under 64, though these results were not conclusive. Further post-hoc analysis indicated a higher proportion of patients in the HLCM051 group showing better recovery and higher Barthel index scores at day 365. While HLCM051 appears safe, its overall efficacy in improving short-term outcomes in AIS patients remains uncertain. Future combined analysis with the ongoing MASTERS-2 trial is expected to provide more insights into the therapy’s efficacy and safety.
Reference: Meglio M. Cell Therapy HLCM051 Fails to Improve Stroke Outcomes Despite Safe Profile. NeurologyLive. Updated January 24, 2024. Accessed January 30, 2024. https://www.neurologylive.com/view/cell-therapy-hlcm051-fails-improve-stroke-outcomes-despite-demonstrating-safe-profile
