Stem Cell Therapies Safe in Early Parkinson's Trials in Japan and U.S./Canada, Show Motor Function Improvements

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Published Apr 16, 2025, 04:11 PM

Two independent clinical trials have demonstrated the safety of stem cell therapies for Parkinson's disease. The first trial, conducted in Japan, involved seven patients aged 50 to 69 who received transplants of dopaminergic progenitors derived from human induced pluripotent stem cells. Over 24 months, no serious adverse events were reported, though there were 73 mild to moderate events, including increased dyskinesia. The transplanted cells produced dopamine without excessive growth or tumor formation, with no graft overgrowth observed. Four out of six patients showed a decrease in motor symptoms associated with Parkinson's disease, though results varied across different measures. The second trial, conducted in the United States and Canada, involved 12 patients with a median age of 67 who received transplants of bemdaneprocel, a product derived from human embryonic stem cells. Over 18 months, the cell product was well tolerated with no serious adverse events related to the therapy, and no incidence of dyskinesia was observed. Improvements in motor function were observed in both the low-dose and high-dose cohorts, with the high-dose group showing a 23-point improvement on a standardized assessment. The 18F-DOPA influx rate in the putamen increased by 44.7%, with higher increases in the high-dose group. No inflammation or graft-induced dyskinesias (GIDs) were reported, and no 5-HT+ cells were detected, indicating the absence of serotonergic neurons in the grafts. Both studies suggest that allogeneic transplantation of stem cell-derived products is safe for treating Parkinson's disease, but larger trials are needed to confirm efficacy.

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