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

NCT06821529 | Not Yet Recruiting Phase 1

• 1 other identifier: (2025)LSYD(0172)H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Incidence and servility of Treatment-Emergent Adverse Events

  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

  From baseline to 12 months post surgery

Secondary Outcomes (5)

• changes in motor function

  From baseline to 12 months post surgery

• Changes in the Hoehn and Yahr scale

  From baseline to 12 months post surgery

• Changes in quality of life (QoL)

  From baseline to 12 months post surgery

• Change in PD medication usage

  From baseline to 12 months post surgery

• 18-F DAT PET uptake

  Baseline, 6 and 12 months post surgery

Study Arms (1)

ICA07 therapy

EXPERIMENTAL

Stereotactic Intracerebral Injection of 4 million iPSC-DAPs into the putamen on each side of the brain .

Biological: ICA07 therapy

Interventions

ICA07 therapy BIOLOGICAL

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

ICA07 therapy

Eligibility Criteria

• Age: 39 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to sign informed consent and comply with the study protocol
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• iCamuno Biotherapeutics Ltd.: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Baorong Zhang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

• Gao Chen

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiali Pu, PhD

CONTACT

+86 13989468062; jialipu@zju.edu.cn

Feng Yan, PhD, MD

CONTACT

+86 13868137422; yan.feng7@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2025
• First Posted: February 12, 2025
• Study Start: May 15, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): September 30, 2026
• Last Updated: February 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)