Back to resultsA Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells
Primary Purpose
Parkinson Disease
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Ips-nsc cells
Sponsored by
About this trial
This is an interventional health services research trial for Parkinson Disease
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ips-nsc treatment group
Arm Description
Outcomes
Primary Outcome Measures
occurrence of treatment related adverse events
occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.
Secondary Outcome Measures
Full Information
NCT ID
NCT03815071
First Posted
January 21, 2019
Last Updated
January 30, 2019
Sponsor
Allife Medical Science and Technology Co., Ltd.
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT03815071
Brief Title
A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells
Official Title
Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2019 (Anticipated)
Primary Completion Date
February 1, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allife Medical Science and Technology Co., Ltd.
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ips-nsc treatment group
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Ips-nsc cells
Intervention Description
Total dose of ips-nsc cells will be administered at day0.
Primary Outcome Measure Information:
Title
occurrence of treatment related adverse events
Description
occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells
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