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NCT06821529

PHASE1

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

Sponsor: iCamuno Biotherapeutics Ltd.

View on ClinicalTrials.gov

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 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.

Official title: Stereotactic Intracerebral Injection of Autologous Induced Pluripotent Stem Cell-derived Dopamine Progenitor Cells in Patients with Parkinson's Disease

Key Details

Gender

All

Age Range

39 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2025-05-15

Completion Date

2026-09-30

Last Updated

2025-02-12

Healthy Volunteers

Conditions

Parkinson Disease

Interventions

BIOLOGICAL

ICA07 therapy

4 million iPSC-DAPs will be administrated into the putamen on each side of the brain

Inclusion Criteria: * Able to sign informed consent and comply with the study protocol * 39-75 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 2.5 - 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 Criteria: * 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

Locations (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China