A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells

NCT ID: NCT03815071

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-01
• Study Completion Date: 2021-02-01

Brief Summary

This is a single center, single arm and open-label study to investigate the safety and efficacy of iPS-NCS with Parkinson's Disease

Conditions

Parkinson Disease

Study Design

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

Study Groups

ips-nsc treatment group

Group Type: EXPERIMENTAL

Ips-nsc cells

Intervention Type: DRUG

Total dose of ips-nsc cells will be administered at day0.

Interventions

Ips-nsc cells

Total dose of ips-nsc cells will be administered at day0.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. The subject is able to understand the research requirements, provide written informed consent, and complete the study in accordance with the procedures;

2. The subject is clearly diagnosed with Parkinson's;

3. Recorded disease progression over the past 6 months;

4. Vital organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥ 50%, no obvious abnormality in ECG; blood oxygen saturation ≥ 90%; creatinine clearance calculated by Cockcroft-Gault formula ≥ 40ml/min; ALT and AST ≤ 3 times the normal range, total bilirubin ≤ 2.0 mg/dl;

5. Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×10/L;

Exclusion Criteria

1. Mental illness or a neurological disease not associated with Parkinson's disease;

2. Serious other concomitant diseases (tumor, organ failure, etc.);

3. Subjects used a large amount of corticosteroids, immunoglobulins, immunosuppressants before entering the study;

4. Participated in other clinical trials of cell preparations and participated in other clinical trials within 3 months;

5. There are already cognitive impairments or depressions, etc., and the research cannot be completed well;

6. Female subjects who are breast-feeding or have a pregnancy plan recently.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital

UNKNOWN

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Beijing Hospital

OTHER_GOV

Sponsor Role: collaborator

Allife Medical Science and Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

NSC-PD-YNYY-01

Identifier Type: -

Identifier Source: org_study_id