Status:
UNKNOWN
A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells
Lead Sponsor:
Allife Medical Science and Technology Co., Ltd.
Collaborating Sponsors:
The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital
Henan Provincial People's Hospital
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-60 years
Phase:
EARLY_PHASE1
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
Eligibility Criteria
Inclusion
- 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;
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03815071
Start Date
February 1 2019
End Date
February 1 2021
Last Update
January 31 2019
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