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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03815071
• Other study ID #: NSC-PD-YNYY-01
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: February 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: January 2019
• Source: Allife Medical Science and Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: February 1, 2021
• Est. primary completion date: February 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• Ips-nsc cells
Total dose of ips-nsc cells will be administered at day0.

Locations

Country	Name	City	State
n/a

Sponsors (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	occurrence of treatment related adverse events	occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.	1 year