Stereotactic Intracerebral Injection of Allogenic IPSC-DAPs in Patients With Parkinson's Disease

Starting soon · Phase 1

Conditions studied: Parkinson Disease

In brief

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 primarily manage symptoms but do not halt or reverse neuronal loss. Cellular replacement therapy has emerged as a potential strategy to restore dopaminergic function and address the underlying neuronal deficits. This study aims to evaluate the safety, feasibility, and efficacy of transplanting dopaminergic neurons into the brain to improve motor function and quality of life in patients with advanced Parkinson's disease.

Key facts

Study ID

NCT07212088

Run by

iCamuno Biotherapeutics Ltd.

People needed

12

Starts

2026-02-28

Expected to finish

2028-06-15

Last updated by the study team

2026-02-11

Who can join

Age: 55 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China

Full record on ClinicalTrials.gov

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