Safety and Efficacy of Autologous iNSC-DAP in the Treatment of Parkinson's Disease

Last updated: June 20, 2023
Sponsor: Xuanwu Hospital, Beijing
Overall Status: Active - Recruiting

Phase

1

Condition

Parkinson's Disease

Dyskinesias

Treatment

Autologous induced neural stem cell-derived DA precursor cells

Clinical Study ID

NCT05901818
CTC001
  • Ages 30-85
  • All Genders

Study Summary

This is a phase I, interventional, single arm, open-label, clinical study to evaluate the safety and efficacy of the striatal transplantation of autologous induced neural stem cell-derived DA precursor cells in Parkinson's Disease patients.

Eligibility Criteria

Inclusion

Inclusion Criteria: Ages between 30 and 85 years, males or females; Diagnosed to be Parkinson's diseasepatients according to MDS Parkinson's disease diagnostic criteria; Disease history over 3years; Hoehn and Yahr Stage less than or equal to 4 during the medication "on" time;Responsive to levodopa treatment (Maximum rate of improvement in MDS-UPDRS, part 3, is over 30%).

Exclusion

Exclusion Criteria: Atypical Parkinsonian syndrome or secondary Parkinsonian syndrome; Accompanied with othercentral nervous system diseases; With other severe systemic diseases or dysfunction; Withsevere psychiatric disorders; Subjects are using hormone or cytotoxic drugs and cannot stoptaking the drug during the trial; With cognitive disorders (MMSE<24); With severedyskinesia (MDS-UPDRS part 4, score in 4.1/4.2 ≥ 2); Subjects have undergone previous brainsurgery; Subjects are long-term user of anticoagulant; Subjects have intracranial lesionswhich may affect the surgery or follow-up studies as assessed by imaging; Subjects areunable to undergo MRI or AV133 PET examination; Pregnancy or in preparation for pregnancy;Not suitable to participate in this clinical trial as assessed by the studyinvestigators/physicians.

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Autologous induced neural stem cell-derived DA precursor cells
Phase: 1
Study Start date:
June 13, 2023
Estimated Completion Date:
December 31, 2026

Study Description

Parkinson's Disease (PD) is the second most common neurodegenerative disease, caused by progressive depletion of midbrain dopaminergic neurons in the substantia nigra pars compacta. This clinical study will include the preparation of dopaminergic neural precursor cells derived from neural stem cells through reprogramming of patient's peripheral blood mononuclear cells (PBMCs), and transplantation of the obtained cells into the brains of PD patients by stereotaxic injection. Safety, tolerability, evidence of cell survival (using PET scan), and the efficacy on PD symptoms will be assessed at different time points up to 12 months post-transplantation.

Connect with a study center

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing 100053
    China

    Active - Recruiting

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