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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03815071
• Date of registration: 21/01/2019
• Prospective Registration: Yes
• Primary sponsor: Allife Medical Science and Technology Co., Ltd.
• Public title: A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells
• Scientific title: Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease
• Date of first enrolment: February 1, 2019
• Target sample size: 10
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT03815071
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label).
• Phase: Early Phase 1

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: Ips-nsc cells

Primary Outcome(s)

occurrence of treatment related adverse events [Time Frame: 1 year]

Secondary ID(s)

NSC-PD-YNYY-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Henan Provincial People's Hospital

Beijing Hospital

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