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

• Status: Unknown status
• Trial end date: 2021-02-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Allife Medical Science and Technology Co., Ltd.
• Collaborators: Beijing Hospital; Henan Provincial People's Hospital; The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital

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.