Parkinson Disease
Conditions
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
Interventions
DRUGIps-nsc cells
Total dose of ips-nsc cells will be administered at day0.
Sponsors
The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital
Henan Provincial People's Hospital
Beijing Hospital
Allife Medical Science and Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| occurrence of treatment related adverse events | 1 year | occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment. |
Outcome results
None listed