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

Allife Medical Science and Technology

Status and phase: Unknown; Early Phase 1

Conditions: Parkinson Disease

Treatments: Drug: Ips-nsc cells

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03815071

NSC-PD-YNYY-01

Details and patient eligibility

About

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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

ips-nsc treatment group

Experimental group

Treatment:

Drug: Ips-nsc cells