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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03815071
Recruitment Status : Not yet recruiting
First Posted : January 24, 2019
Last Update Posted : January 31, 2019
Sponsor:
Collaborators:
The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital
Henan Provincial Hospital
Beijing Hospital
Information provided by (Responsible Party):
Allife Medical Science and Technology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE January 21, 2019
First Posted Date  ICMJE January 24, 2019
Last Update Posted Date January 31, 2019
Estimated Study Start Date  ICMJE February 1, 2019
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2019)
occurrence of treatment related adverse events [ Time Frame: 1 year ]
occurrence of treatment related adverse events that are possible, likely. Or definitely related to study treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03815071 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study on the Treatment of Parkinson's Disease With Autologous Neural Stem Cells
Official Title  ICMJE Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease
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 Provided
Study Type  ICMJE Interventional
Study Phase Early Phase 1
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Drug: Ips-nsc cells
Total dose of ips-nsc cells will be administered at day0.
Study Arms Experimental: ips-nsc treatment group
Intervention: Drug: Ips-nsc cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 23, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date February 1, 2021
Estimated Primary Completion Date February 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03815071
Other Study ID Numbers  ICMJE NSC-PD-YNYY-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Allife Medical Science and Technology Co., Ltd.
Study Sponsor  ICMJE Allife Medical Science and Technology Co., Ltd.
Collaborators  ICMJE
  • The First People's Hospital of Yunnan Province/First People's Hospital of Yunan Provinve New Kunhua Hospital
  • Henan Provincial Hospital
  • Beijing Hospital
Investigators  ICMJE Not Provided
PRS Account Allife Medical Science and Technology Co., Ltd.
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP