Actively Recruiting
A Clinical Trial of Parkinson's Disease Treatment by Human-induced Pluripotent Stem Cells Derived Dopaminergic Neural Precursor Cells
Led by Shanghai East Hospital · Updated on 2024-10-15
3
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
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 Parkinson's 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 Parkinson's disease. The treatment involves preparing dopaminergic neural precursor cells from each participant's 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 Parkinson's Disease Rating Scale and Hoehn and Yahr scale, PET/MRI 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.
CONDITIONS
Brief Title
A Clinical Trial of Parkinson's Disease Treatment by HiPSCs Derived Dopaminergic Neural Precursor Cells
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient or authorized guardian consents and signs informed consent
- Diagnosed with primary Parkinson's disease, aged 30 to 70 years, any gender
- Disease duration over 5 years
- Hoehn-Yahr stage 3 to 4, or below 3 if refusing other treatments
- MDS-UPDRS-III score during OFF periods above 38 with stable scores
- Stable anti-Parkinson drug therapy for more than 3 months
- History of effective levodopa treatment with resistance and wearing-off
- Stable condition with controlled complications and no anesthesia or surgery contraindications
- No structural brain abnormalities on MRI affecting transplantation
- Has a caregiver able to provide condition information and assist investigators
You will not qualify if you...
- Atypical or secondary Parkinson's disease
- Parkinson's disease with only tremors
- Severe motor impairment preventing routine tasks
- Severe neurological deficits from other diseases
- Severe psychiatric symptoms or dementia
- Unwillingness or inability to cooperate or self-assess
- History of pallidotomy, thalamotomy, or deep brain stimulation surgery
- Current apomorphine treatment
- Coagulation abnormalities or anticoagulation therapy
- Pregnancy, lactation, or inability to use effective contraception
- Participation in other clinical studies within 3 months
- Recent treatment for muscle tone disorders or spasticity
- History of seizures or antiepileptic drug use
- Contraindications for anesthesia or stereotactic surgery
- Unstable systemic diseases including infections, hypertension, heart failure, or metabolic diseases
- Alcohol or drug abuse
- Recent high-dose benzodiazepine use
- Severe cognitive impairment or depression
- History of malignant tumors
- Active or past infections including hepatitis, HIV, or syphilis
- Abnormal liver or kidney function tests
- Any condition deemed unsuitable by investigator
- Parkinson's disease gene mutations detected by genetic testing
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo general anesthesia and receive an injection of autologous iPSC-derived dopaminergic neural precursor cells into the putamen of the striatum on one side using stereotactic technology. A drug pouch is installed to monitor neurotransmitter metabolism in the brain.
1 visit (in-person)
Duration - 6 to 24 months depending on treatment response
Participants are regularly observed to assess safety and efficacy of the stem cell treatment. If safety is confirmed but efficacy is insufficient at 6 months, a second surgery is performed on the other side followed by extended observation.
Visits at day 0, 1 month, 3 months, 6 months, 9 months, 12 months, 15 months, and 18 months; periodic reviews every 6 months
Trial Site Locations
Total: 2 locations
1
Shanghai East Hospital
Shanghai, Shanghai Municipality, China, 200120
Actively Recruiting
2
Shanghai East Hospital
Shanghai, Shanghai Municipality, China
Not Yet Recruiting
Research Team
W
WU jingwen Shanghai East Hospital
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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