Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease

Allife Medical Science and Technology Co., Ltd.0 sites10 target enrollmentFebruary 1, 2019

Overview

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

Registry

clinicaltrials.gov

Start Date

February 1, 2019

End Date

February 1, 2021

Last Updated

7 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

Allife Medical Science and Technology Co., Ltd.

Responsible Party

Sponsor

•The subject is able to understand the research requirements, provide written informed consent, and complete the study in accordance with the procedures;
•The subject is clearly diagnosed with Parkinson's;
•Recorded disease progression over the past 6 months;
•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;
•Blood routine: Hgb≥80g/L, ANC≥1×109/L, PLT≥50×10/L;

•Mental illness or a neurological disease not associated with Parkinson's disease;
•Serious other concomitant diseases (tumor, organ failure, etc.);
•Subjects used a large amount of corticosteroids, immunoglobulins, immunosuppressants before entering the study;
•Participated in other clinical trials of cell preparations and participated in other clinical trials within 3 months;
•There are already cognitive impairments or depressions, etc., and the research cannot be completed well;
•Female subjects who are breast-feeding or have a pregnancy plan recently.