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

iCamuno Biotherapeutics Ltd.

Status and phase

Not yet enrolling

Phase 1

Conditions

Parkinson Disease

Treatments

Biological: ICA07 therapy

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT06821529

(2025)LSYD(0172)H

Details and patient eligibility

About

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.

Full description

Patients with Parkinson's disease will be treated with autologous 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.

Enrollment

12 estimated patients

Sex

All

Ages

39 to 75 years old

Volunteers

No Healthy Volunteers

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