NCT06145711 A Clinical Trial of Parkinson's Disease Treatment by HiPSCs Derived Dopaminergic Neural Precursor Cells
| NCT ID | NCT06145711 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shanghai East Hospital |
| Condition | Parkinson's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 3 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2025-12-22 |
Trial Parameters
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Brief Summary
XellSmart Biomedical (Suzhou) Co., Ltd. has closely collaborated with Shanghai East Hospital(East Hospital Affiliated To Tongji University) , using iPSC seed cells, on the development and establishment of a dopaminergic neural precursor cell production system. This study is conducted under collaboration between Shanghai East Hospital and XellSmart Biomedical (Suzhou) Co., Ltd. It is a distinctive stem cell therapy research targeting Parkinson's disease patients, characterized by the following: 1. The first instance in China of using autologous iPSC-derived subtype-specific dopaminergic neural precursor cells for alternative transplantation therapy in Parkinson's disease. 2. Before the initiation of this study, there was only one reported case around the world involving the use of laboratory-grade autologous iPSC-induced dopaminergic neural precursor cells for Parkinson's disease treatment in an American Caucasian individual. Positive preliminary clinical research results were obtained and published in the New England Journal of Medicine in 2020. Since then, no similar studies have been reported. It has great significance to conduct this research. It will fill two critical clinical research gaps in stem cell therapy for Parkinson's disease in the world: 1. The use of clinical-grade autologous iPSCs differentiated into dopaminergic neural cells, and treat Parkinson's disease. 2. Evaluating the safety of using autologous iPSC-differentiated dopaminergic neural cells for Parkinson's disease treatment in individuals of Asian descent or Chinese ethnicity.
Eligibility Criteria
Inclusion Criteria: 1. The patient or their legally authorized guardian consents to participate in this study and signs the Informed Consent Form (ICF) in writing. 2. Patients with primary Parkinson's disease, aged between 30 and 70 years, of any gender, with a disease duration of more than 5 years. 3. Hohen-Yahr stage for Parkinson's disease (Appendix V) is between stage 3 and stage 4. Patients with a Hohen-Yahr stage below 3 who refuse other treatments may also be included. 4. The MDS-UPDRS-III score for "OFF" periods in Parkinson's disease is greater than 38 points, and the MDS-UPDRS-III score for the two "OFF" periods before surgery is stable, i.e., (high value - low value) / high value is less than or equal to 10%. 5. Patients who have stably received anti-Parkinson drug therapy for more than 3 months. 6. Previous effective treatment with levodopa, followed by significant drug resistance and wearing-off effect. 7. The patient who is in stable condition, well-controlled complicatio
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