ALC01 therapy: A single dose of iPSC-DAPs will be administered into the putamen on each side of the brain
Study 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.
Eligibility
Sex
ALL
Min age
55 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Incidence and servility of Treatment-Emergent Adverse Events — From baseline to 12 months post surgery Incidence of adverse event (AE), serious adverse event(SAE) is defined as the composite of number and severity of adverse events, regardless of causality, clinical laboratory abnormalities, clinical meaningful changes from baseline
Trial sites (1)
Facility
City
Region
Status
Second Affiliated Hospital Zhejiang University School of Medicine
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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