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Not yet recruiting NCT07212088

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

Phase I Interventional Parkinson Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALC01 therapy.
Who it may be relevant to
Registry conditions: Parkinson Disease. Basic parameters: 55 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Stereotactic Intracerebral Injection of Allogenic Induced Pluripotent Stem Cell-derived Dopamine Progenitor Cells in Patients With Parkinson's Disease

Overview

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.

Interventions

  • Biological ALC01 therapy
    A single dose of iPSC-DAPs will be administered into the putamen on each side of the brain

Primary outcome measures

  • Incidence and servility of Treatment-Emergent Adverse Events [Time frame: From baseline to 12 months post surgery]
Secondary outcome measures (5)
  • Changes in motor function [Time frame: From baseline to 12 months post surgery]
  • Changes in the Hoehn and Yahr scale [Time frame: From baseline to 12 months post surgery]
  • Changes in quality of life (QoL) [Time frame: From baseline to 12 months post surgery]
  • Change in PD medication usage [Time frame: From baseline to 12 months post surgery]
  • 18-F DAT PET uptake [Time frame: Baseline, 6 and 12 months post surgery]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT07212088 · (2025)LSYD(1419)H

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗