Overview
- Researchers reported on Thursday that the STEM-PD open-label phase 1/2 trial successfully transplanted pluripotent stem cell–derived dopaminergic progenitors into eight people with Parkinson’s disease and met its primary feasibility and safety endpoint at 12 months.
- Seven participants completed one-year follow-up with no serious adverse events attributed to the transplanted cells and no graft-induced involuntary movements, while one participant died of a pulmonary infection judged not to be linked to the cell product.
- Dopamine PET scans at six and 12 months provided early imaging evidence consistent with graft survival and six of the seven surviving participants substantially reduced their dopaminergic medications.
- The trial used bilateral intraputaminal injections of progenitors derived from human embryonic pluripotent stem cells and gave participants 12 months of immunosuppression to lower the risk of graft rejection.
- The team will continue long-term monitoring to assess graft maturation, durability, and clinical benefit and the program has been acquired by Cellular Intelligence, which plans further clinical development including a planned phase II trial.