Parkinsons Disease Treatment Using Patient-Derived Stem Cells Safety Study of Dopaminergic Neural Precursor Cell Transplantation Using Human-Induced Pluripotent Stem Cells hiPSCs

What this Trial Is About

Researchers are investigating a stem cell therapy using autologous induced pluripotent stem cell iPSC-derived dopaminergic neural precursor cells for treating Parkinsons disease. This study aims to evaluate the safety of this innovative approach, especially in patients of Asian descent or Chinese ethnicity. It is a non-randomized, open-label clinical trial conducted through collaboration between Shanghai East Hospital and XellSmart Biomedical Suzhou Co., Ltd., addressing important gaps in stem cell therapy research for Parkinsons disease. The treatment involves preparing dopaminergic neural precursor cells from each participants own iPSCs. Under general anesthesia, these cells will be injected into one side of the putamen in the brain using stereotactic technology. A device called the Sofia drug pouch will be installed to monitor brain neurotransmitter changes over time. Participants will be observed regularly over 6 months to assess safety and potential benefits. Depending on results, a second injection may be administered on the opposite brain side, followed by long-term monitoring lasting up to 24 months. Participants will undergo various assessments including clinical symptom evaluations, rating scales like the Unified Parkinsons Disease Rating Scale and Hoehn and Yahr scale, PETMRI scans, and medication usage tracking at multiple time points. Safety will be closely monitored by recording any adverse events. The primary outcome focuses on the number of participants experiencing adverse effects over 18 months. Regular follow-ups and periodic clinical reports will guide ongoing research and participant care throughout the study duration.

A Clinical Trial of Parkinson's Disease Treatment by HiPSCs Derived Dopaminergic Neural Precursor Cells