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

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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.

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

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: Ips-nsc cells Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Clinical Study of the Safety and Efficacy of Autologous Neural Stem Cells in the Treatment of Parkinson's Disease
Estimated Study Start Date : February 1, 2019
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ips-nsc treatment group Drug: Ips-nsc cells
Total dose of ips-nsc cells will be administered at day0.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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Responsible Party: Allife Medical Science and Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03815071     History of Changes
Other Study ID Numbers: NSC-PD-YNYY-01
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases