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

NCT ID: NCT05901818

Last Updated: 2023-06-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-13
• Study Completion Date: 2026-12-31

Brief 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.

Detailed 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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Autologous induced neural stem cell-derived DA precursor cells

The patients will receive transplantation of autologous induced neural stem cell-derived DA precursor cells.

Group Type: EXPERIMENTAL

Autologous induced neural stem cell-derived DA precursor cells

Intervention Type: DRUG

The autologous induced neural stem cell-derived DA precursor cells will be stereotactically implanted into the striatum of PD patients.

Interventions

Autologous induced neural stem cell-derived DA precursor cells

The autologous induced neural stem cell-derived DA precursor cells will be stereotactically implanted into the striatum of PD patients.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Ages between 30 and 85 years, males or females; Diagnosed to be Parkinson's disease patients according to MDS Parkinson's disease diagnostic criteria; Disease history over 3 years; 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 Criteria

Atypical Parkinsonian syndrome or secondary Parkinsonian syndrome; Accompanied with other central nervous system diseases; With other severe systemic diseases or dysfunction; With severe psychiatric disorders; Subjects are using hormone or cytotoxic drugs and cannot stop taking the drug during the trial; With cognitive disorders (MMSE<24); With severe dyskinesia (MDS-UPDRS part 4, score in 4.1/4.2 ≥ 2); Subjects have undergone previous brain surgery; Subjects are long-term user of anticoagulant; Subjects have intracranial lesions which may affect the surgery or follow-up studies as assessed by imaging; Subjects are unable 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 study investigators/physicians.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xuanwu Hospital, Beijing

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhiguo Chen, Ph.D.

Role: CONTACT

chenzhiguo@gmail.com

+86-10-83198889

Jinghong Ma, M.D.

Role: CONTACT

jinghongma@163.com

+86-10-83198677

Facility Contacts

Zhiguo Chen, Ph.D.

Role: primary

chenzhiguo@gmail.com

86-10-83198889

Other Identifiers

CTC001

Identifier Type: -

Identifier Source: org_study_id