Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03186456
Recruitment Status : Unknown
Verified April 2017 by Sclnow Biotechnology Co., Ltd..
Recruitment status was:  Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.

Tracking Information
First Submitted Date  ICMJE June 6, 2017
First Posted Date  ICMJE June 14, 2017
Last Update Posted Date June 14, 2017
Estimated Study Start Date  ICMJE July 2017
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
Treatment related-adverse events counting [ Time Frame: 26 weeks ]
patients will be monitored for any adverse events resulting from the treatment of Human Umbilical Cord Mesenchymal Stem Cells
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 12, 2017)
  • Modified Rankin Scale [ Time Frame: 26 weeks ]
    After the first time transplantation, follow-up visit for 26 weeks. Based on Modified Rankin Scale, counting the percentage of different symptom changes to evaluate MSC efficacy:
    • the percentage of participants run from 0-1, no symptom or no significant disability.
    • the percentage of participants run from 0-2, no symptom or slight disability.
    • the percentage of participants decline 2 scales compare to baseline.
    • the percentage of participants decline 1 scale compares to baseline.
  • Barthel activities of daily living (ADL) Index [ Time Frame: 26 weeks ]
    Based on Activity of Daily Living Scale (ADL) to counting the percentage of patients in following condition:
    • the percentage of patients with score > 75
    • the decline of Barthel ADL Index range compares to baseline. Evaluate the efficacy of MSCs treatment
  • NIH stroke scale (NIHSS) [ Time Frame: 26 weeks ]
    According to NIHSS changes after the treatment, evaluate MSCs efficacy by counting the percentage of patients in following condition:
    • the percentage of patients with score 0-1;
    • the percentage of patients with score declined 7 compare to baseline;
    • the percentage of patients with score declined 50% compare to baseline;
    • the declined ranges compare to baseline
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction
Official Title  ICMJE Study the Safety and Efficacy of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction
Brief Summary The purposes of the study is to determine the safety and efficacy of treating acute ischemic stroke patients with human umbilical cord mesenchymal stem cells (hUC-MSC).
Detailed Description This is a randomized, double-blind, paralleled study. 40 patients will be separated into two groups, and receive basic treatment (Aspirin Tablet). Patients in experimental group will receive hUC-MSC once a month, total 3 times. After the treatment, investigator will have follow-up visit for 6 months, evaluate the security and efficacy of hUC-MSC.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Cerebral Infarction
Intervention  ICMJE
  • Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
    Allogeneic umbilical cord mesenchymal stem cells will transfusion into by forearm intravenous transplantation, 0.5 - 1 *10^6/kg. once a month, total 3 times.
  • Drug: Aspirin Tablet
    Drug: Aspirin Tablet, 100 mg/d
Study Arms  ICMJE
  • Experimental: Group 1
    Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg
    Interventions:
    • Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)
    • Drug: Aspirin Tablet
  • Placebo Comparator: Group 2
    Aspirin Tablet, 100mg/d; Placebo
    Intervention: Drug: Aspirin Tablet
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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 12, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2018
Estimated Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient within 2 weeks onset of symptoms.
  • Symptoms and signs of clinically definite acute cerebral infarction patients.
  • CT/MRI prove the Oxfordshire Community Stroke Project (OCSP) as Total Anterior circulation infarct (TACI), Partial Anterior circulation infarct (PACI), Posterior Anterior circulation infarct (POCI), or obvious neurological deficit lacunar infarction patient.
  • Signed informed consent after understanding all possible benefits and harm.

Exclusion Criteria:

  • allergic to basic drug
  • with progressive stroke, transient ischemia attach, cerebral infarction with posterior cerebral hemorrhage, and cerebral arteritis.
  • tumor, injury, and parasites caused cerebral embolism
  • rheumatic heart disease, coronary heart disease, and other atrial fibrillation combined heart disease caused cerebral embolism
  • subject is processing thrombolytic therapy
  • subject is pregnancy and of childbearing potential or breast feeding
  • participate in any other clinical trial in last 3 months
  • bleeding tendency patient; severe bleeding tendency in last 3 month
  • with gastric duodenal ulcer
  • participants with severe liver and kidney, hematopoietic, and metabolic diseases; Or with liver and kidney function examination abnormal
  • participants are intolerance with Aspirin Enteric-coated Tablets, or need other antiplatelet drugs
  • participants: alcoholism, drug addicted, or other situations may complicated the results
  • under other therapy that possibly influence MSC security or efficacy
  • investigator supposes not suitable to participate this clinical trail
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03186456
Other Study ID Numbers  ICMJE SCLnow-IMIMH-02
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sclnow Biotechnology Co., Ltd.
Study Sponsor  ICMJE Sclnow Biotechnology Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Temuqile Inner Mongolia International Mongolian Hospital
Study Chair: Lei Guo, Dr. China-Japan Union Hospital, Jilin University
PRS Account Sclnow Biotechnology Co., Ltd.
Verification Date April 2017

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