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NCT Number: NCT06821529

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

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.

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Key information

Conditions

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

Age range

39 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICA07 therapy

Biological

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

Primary outcomes

  1. Incidence and servility of Treatment-Emergent Adverse Events

    Time frame: 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

Secondary outcomes

  1. changes in motor function

    Time frame: From baseline to 12 months post surgery

    Changes in motor function that measured by Movement and Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III. TheMDA- UPDRS Part III score ranges from 0 to 132, with higher score indicating greater disability

  2. Changes in the Hoehn and Yahr scale

    Time frame: From baseline to 12 months post surgery

    Hoehn and Yahr scale is used to provide a general estimate of clinical function of PD patients, combining functional deficits (disability) and objective signs (impairment). The Hoehn and Yahr score ranges from 0 to 5, with higher score indicating higher dysfunction of PD patients

  3. Changes in quality of life (QoL)

    Time frame: From baseline to 12 months post surgery

    Measured by Parkinson's Disease Quality of Life Rating Scale (PDQ-39) from baseline to 12 months post surgery.

    PDQ-39 score ranges from 0 to 156 and provides the evidence of the quality of life of a PD patient. The higher the score, the lower the quality of life of PD patients.

  4. Change in PD medication usage

    Time frame: From baseline to 12 months post surgery

    Change in the Parkinson's disease medication usage as defined by the levodopa equivalent daily dose (LEDD)

  5. 18-F DAT PET uptake

    Time frame: Baseline, 6 and 12 months post surgery

    Changes in putamen 18F DAT PET uptake that measured by PET/CT

Study contacts

Contact information is provided by the study sponsor or research team.

Feng Yan, PhD, MD

CONTACT

[email protected]

+86 13868137422

Jiali Pu, PhD

CONTACT

[email protected]

+86 13989468062

Sponsors and collaborators

Lead sponsor

iCamuno Biotherapeutics Ltd.

Industry

Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 12, 2025
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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