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

NCT ID: NCT07212088

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2028-06-15

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 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.

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 striatum to restore dopamine-producing capacity. Patients will be evaluated at 1, 3, 6, 9 and 12 months after transplantation for safety, feasibility, and efficacy.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Low Dose ALC01 therapy

Stereotactic Intracerebral Injection of iPSC-DAPs into the putamen on each side of the brain

Group Type: EXPERIMENTAL

ALC01 therapy

Intervention Type: BIOLOGICAL

A single dose of iPSC-DAPs will be administered into the putamen on each side of the brain

High Dose ALC01 therapy

Stereotactic Intracerebral Injection of iPSC-DAPs into the putamen on each side of the brain

Group Type: EXPERIMENTAL

ALC01 therapy

Intervention Type: BIOLOGICAL

A single dose of iPSC-DAPs will be administered into the putamen on each side of the brain

Interventions

ALC01 therapy

A single dose of iPSC-DAPs will be administered into the putamen on each side of the brain

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• 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 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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: collaborator

iCamuno Biotherapeutics Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gao Chen, PhD, MD

Role: STUDY_CHAIR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Feng Yan, PhD, MD

Role: CONTACT

yan.feng7@163.com

+86 13868137422

Facility Contacts

Feng Yan Second Affiliated Hospital, School of Medicine, Zhejiang Unive, PhD, MD

Role: primary

yan.feng7@163.com

+86 13868137422

Other Identifiers

(2025)LSYD(1419)H

Identifier Type: -

Identifier Source: org_study_id