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

Early Phase 1

• Conditions: Parkinson Disease
• Interventions: Drug: Ips-nsc cells

• Registration Number: NCT03815071
• Lead Sponsor: Allife Medical Science and Technology Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-01
• Study First Submitted: 2019-01-21
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-24
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31
• Study Start: 2019-02-01
• Primary Completion: 2020-02-01
• Study Completion: 2021-02-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ips-nsc treatment group	Ips-nsc cells	-

Primary Outcome Measures

Name	Time	Method
occurrence of treatment related adverse events	1 year	occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.