BlueRock Therapeutics says that its Phase I trial of bemdaneprocel (BRT-DA01), a cell therapy for Parkinson’s disease, produced positive results at 36 months. The company claims the therapy remains safe, with evidence of implanted cell survival and clinical trends consistent with earlier observations.
The trial enrolled 12 participants in an open-label, non-randomized study. All participants underwent bilateral implantation of dopamine neuron precursors (derived from pluripotent stem cells) into the putamen, followed by a 12-month immunosuppression regimen. Two dosing levels were tested: 0.9 million cells per putamen in one cohort and 2.7 million in another.
According to BlueRock, over the 36-month follow-up period there were no new serious adverse events related to the cell therapy. The company says neuroimaging and other biomarker assessments continue to support survival, engraftment, and function of the transplanted cells. The reported clinical outcomes reportedly remain consistent with earlier 12-, 18- and 24-month data, although no detailed efficacy metrics were disclosed.
BlueRock previously secured Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. FDA for bemdaneprocel, which grants accelerated development privileges. The company plans to initiate a registrational Phase III trial, called exPDite-2, expected to enroll around 102 patients and compare treatment to sham surgery in a double-blind design. The primary endpoint will measure change in “ON-time without troublesome dyskinesia” over 78 weeks.
The 36-month report reinforces BlueRock’s narrative of a durable safety and biological signal in its first-in-class cell therapy for Parkinson’s, though the company’s claims await confirmatory evidence from larger, controlled trials.
