Status:
NOT_YET_RECRUITING
Stereotactic Intracerebral Injection of Allogenic IPSC-DAPs in Patients With Parkinson's Disease
Lead Sponsor:
iCamuno Biotherapeutics Ltd.
Collaborating Sponsors:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Parkinson Disease
Eligibility:
All Genders
55-75 years
Phase:
PHASE1
Brief Summary
Parkinson's disease is a progressive neurodegenerative disorder characterized by high morbidity due to the limited regenerative capacity of dopaminergic neurons in the brain. Current drug treatments p...
Detailed Description
Patients with Parkinson's disease will be treated with allogenic induced pluripotent stem cell-derived dopamine progenitor cells (iPSC-DAPs). These cells will be transplanted directly into the striatu...
Eligibility Criteria
Inclusion
- Able to sign informed consent and comply with the study protocol
- 55-75 years of age, at the time of signing informed consent
- Diagnosed to be Parkinson's disease patients over 5 years
- Taking levodopa, but with complications of therapy such as wearing off and/or dyskinesia
- At least 3 hours accumulative "off" time per day
- Hoehn and Yahr Stage 3 - 4 in the off state at screening
- Dopamine drug responsiveness demonstrated by a positive "on/off" test with at least a 30% improvement on UPDRS III (motor) scale
Exclusion
- Patients with the following concomitant conditions or disorders: Epilepsy；Multiple sclerosis；Unable to give consent due to dementia；Atypical Parkinsonism；Genetic Parkinson's disease；Suicidal ideation associated with intent or plan in the past 12 months；History of psychosis；History of subarachnoid hemorrhage；History of stroke or transient ischemic attack
- Patient with unstable vital sign at screening and/or prior to the surgery
- Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73m2
- Liver dysfunction, as evidenced by enzymes (AST and ALT) greater than three times the ULN.
- Hematologic abnormality: hemoglobin \<10 mg/dL or platelet count \< 100,000/mL
- International normalized ratio (INR) ≥ 1.3 not due to a reversible cause
- Patients with autoimmune disorders
- Patients with HIV and/or active HBV or HCV
- Patients who are unable to undergo MRI and PET/CT
- Patients with an expected life expectancy of \<1 year
- Patients who have had active malignancies
- Patients currently receive levodopa-carbidopa intestinal gel or apomorphine treatment
- Patients who have history of pallidotomy or thalamotomy or deep brain stimulation (DBS) surgery
- Received cell or gene therapy (autologous or allogeneic) within the previous 12 months
- Participation in an investigational therapeutic or device trial within 30 days of consent
- Women who are pregnant or breast-feeding
- Other conditions that researchers consider not suitable to participate in this study
Key Trial Info
Start Date :
November 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2028
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07212088
Start Date
November 15 2025
End Date
June 15 2028
Last Update
November 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009