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

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ClinicalTrials.gov Identifier: NCT03186456
Recruitment Status : Not yet recruiting
First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Sclnow Biotechnology Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Cerebral Infarction Biological: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) Drug: Aspirin Tablet Phase 1

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study the Safety and Efficacy of Human Umbilical Cord-derived Mesenchymal Stem Cells in the Treatment of Acute Cerebral Infarction
Estimated Study Start Date : July 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Group 1
Aspirin Tablet, 100mg/d; Allogeneic umbilical cord mesenchymal stem cells, 0.5-1*10^6/kg
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

Placebo Comparator: Group 2
Aspirin Tablet, 100mg/d; Placebo
Drug: Aspirin Tablet
Drug: Aspirin Tablet, 100 mg/d




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03186456


Contacts
Contact: Lei Guo 861064368977 georgeguo@sclnow.com

Locations
China, Inner Mongolia
Inner Mongolia International Mongolian Hospital Not yet recruiting
Hohhot, Inner Mongolia, China, 010065
Contact: Wulantuya    864715182155      
Sponsors and Collaborators
Sclnow Biotechnology Co., Ltd.
Investigators
Study Director: Temuqile Inner Mongolia International Mongolian Hospital
Study Chair: Lei Guo, Dr. China-Japan Union Hospital, Jilin University

Responsible Party: Sclnow Biotechnology Co., Ltd.
ClinicalTrials.gov Identifier: NCT03186456     History of Changes
Other Study ID Numbers: SCLnow-IMIMH-02
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Sclnow Biotechnology Co., Ltd.:
acute cerebral infarction
umbilical cord mesenchymal stem cells

Additional relevant MeSH terms:
Infarction
Cerebral Infarction
Ischemia
Pathologic Processes
Necrosis
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Stroke
Vascular Diseases
Cardiovascular Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics