RecruitingNot ApplicableNCT06145711

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

A Clinical Trial of Parkinson's Disease Treatment by Human-induced Pluripotent Stem Cells (hiPSCs) Derived Dopaminergic Neural Precursor Cells


Sponsor

Shanghai East Hospital

Enrollment

3 participants

Start Date

Nov 23, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 30 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This is a clinical trial testing the safety and effectiveness of transplanting stem cells derived from reprogrammed human skin or blood cells (called HiPSC-derived dopaminergic precursor cells) into the brain to treat moderate-to-severe Parkinson's disease. **You may be eligible if...** - You are between 30 and 70 years old with primary Parkinson's disease for more than 5 years - Your Parkinson's is at a moderate-to-severe stage (Hoehn-Yahr stage 3 or 4) - Your Parkinson's medication previously worked (levodopa) but has become less effective over time - You are medically stable and can tolerate general anesthesia - You have a caregiver who can support you through the study **You may NOT be eligible if...** - You have atypical Parkinson's or tremor-dominant Parkinson's disease - You have had prior brain surgery (e.g., deep brain stimulation, thalamotomy) - You are currently using apomorphine - You have severe cognitive problems or depression - You have a history of seizures or take anti-epileptic medications - You have coagulation problems or are on blood thinners - You are pregnant or unable to use contraception - You have active infections, HIV, hepatitis, or syphilis - Genetic testing has found a gene mutation responsible for your Parkinson's Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERhiPSC-DAP

Using hiPSC-DAP for the treatment of the patients of Parkinson's diease


Locations(2)

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

Shanghai East Hospital

Shanghai, Shanghai Municipality, China

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NCT06145711


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