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Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS)

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ClinicalTrials.gov Identifier: NCT04811651
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
Hui-Sheng Chen, General Hospital of Shenyang Military Region

Brief Summary:
This is a doble blind, placebo controlled clinical trial to assess safety and efficacy of intravenous administration of Umbilical cord-derived Mesenchymal Stem cells in patients with ischemic stroke within 6 months of onset.

Condition or disease Intervention/treatment Phase
Ischemic Stroke Biological: Umbilical Cord-derived Mesenchymal Stem Cells Drug: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two different treatment groups; intravenous umbilical cord-derived mesenchymal stem cells or intravenous placebo solution
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Treatment and placebo solutions have identical appearance. Protocols will be designed to ensure that the physician evaluating patient safety and efficacy outcome as well as laboratory analysis, will not have access to the randomisation codes.
Primary Purpose: Treatment
Official Title: Umbilical Cord-derived Mesenchymal Stem Cells for Ischemic Stroke (UMSIS): a Prospective, Double-blinded, Randomized Controlled, Pilot Study
Actual Study Start Date : March 15, 2021
Estimated Primary Completion Date : February 1, 2023
Estimated Study Completion Date : October 1, 2023

Arm Intervention/treatment
Experimental: Treatment group
intravenous umbilical cord derived mesenchymal stem cells
Biological: Umbilical Cord-derived Mesenchymal Stem Cells
umbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million.

Placebo Comparator: Placebo Comparator
intravenous placebo solution with the same appearance as the treatment group.
Drug: Placebo
intravenous placebo solution with the same appearance as the treatment group.




Primary Outcome Measures :
  1. Proportion of modified Rankin Scale (mRS) 0-2 [ Time Frame: 90 Days ]
    the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome


Secondary Outcome Measures :
  1. Proportion of modified Rankin Scale (mRS) 0-2 [ Time Frame: 180,360 Days ]
    the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS mean a worse outcome

  2. changes in Fugl-Meyer scale [ Time Frame: 90days;180days;360days ]
    Fugl-Meyer Assessment Scale ranges from 0 to 100.

  3. changes in Purdue hand function test [ Time Frame: 90days;180days;360days ]
    The changes of fine motor function were evaluated by Purdue hand function test

  4. changes in box and block test [ Time Frame: 90days;180days;360days ]
    The changes of fine motor function were evaluated by box and block test

  5. Proportion of modified Rankin Scale (mRS) 0-1 [ Time Frame: 90days;180days;360days ]
    the minimum and maximum values of mRS are 0 and 6, respectively; higher mRS

  6. changes in the national institutes of health stroke scale (NIHSS) [ Time Frame: 90days;180days;360days ]
    NIHSS ranges from 0-42, and high NIHSS means bad outcome

  7. changes in Mini-mental State Examination (MMSE) score [ Time Frame: 90days;180days;360days ]
    MMSE score ranges from 0 to 30.

  8. changes in Montreal Cognitive Assessment (MoCA) score [ Time Frame: 90days;180days;360days ]
    MOCA score ranges from 0 to 30.

  9. The changes of head images [ Time Frame: 90days;180days;360days ]
    head images included flair, DTI

  10. changes in some serum biomarkers [ Time Frame: 90days;180days;360days ]
    serum biomarkers included CPEC, VEGF, BDNF, MMP-9


Other Outcome Measures:
  1. Number of Adverse Events [ Time Frame: 360days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: 18-80 years old;
  2. Patients with anterior circulation cerebral infarction;
  3. NIHSS: 6-25, and the limb movement score is at least 2 points;
  4. Hemoglobin > 115g / L, platelet > 100 × 109 / L, leukocyte > 3 × 109 / L;
  5. the time from onset to treatment: group A(6-24 hours)、group B(1-3 days)、gourp C(4-7 days)、group D(1-4 weeks)、group E(1-6 months);
  6. The patient or the legal representative of the patient can and is willing to sign the informed consent.

Exclusion Criteria:

  1. Patients who need or expect decompressive craniectomy;
  2. Patients who need or are expected to receive endovascular treatment ;
  3. Patients receiving intravenous thrombolysis;
  4. Disturbance of consciousness;
  5. Pregnant women or women of childbearing age who have not taken effective contraceptive measures;
  6. Intracranial hemorrhagic diseases: cerebral hemorrhage, subarachnoid hemorrhage, etc;
  7. Posterior circulation cerebral infarction;
  8. Tumor patients;
  9. Epilepsy patients;
  10. Severe neurological deficit caused by stroke (MRS = 5);
  11. Previous diseases with obvious functional impairment, such as Parkinson's disease, motor neuron disease, moderate Alzheimer's disease, osteoarthritis, etc;
  12. Patients with history of coagulation disorders, systemic bleeding tendency and thrombocytopenia (< 100000 / mm3);
  13. Chronic liver disease, liver and kidney dysfunction, elevated ALT or ast (2 times higher than the upper limit of normal value), elevated serum creatinine (1.5 times higher than the upper limit of normal value) or dependent on renal dialysis;
  14. Patients with moderate to severe mental illness obviously interfere with treatment compliance;
  15. Patients with high blood pressure (systolic blood pressure > 180mmhg) or low blood pressure (systolic blood pressure < 90mmHg);
  16. The expected survival time is less than one year;
  17. Those who have conducted other trials within 3 months;
  18. Other circumstances considered unsuitable by the researcher.

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): NCT04811651


Contacts
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Contact: Chen Hui-Sheng, Doctor 86-24-28897511 ext 024-28897512 chszh@aliyun.com
Contact: Wang Xin-Hong, Doctor 86-15309885658 450341972@qq.com

Locations
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China
Department of Neurology, General Hospital of Northern Theater Command Recruiting
Shenyang, China, 110016
Contact: Hui-Sheng Chen, Ph.D.    +86 13352452086    chszh@aliyun.com   
Sponsors and Collaborators
General Hospital of Shenyang Military Region
Investigators
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Principal Investigator: Chen Hui-Sheng, Doctor General Hospital of Shenyang Military Region
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Responsible Party: Hui-Sheng Chen, Director of neurology department, General Hospital of Shenyang Military Region
ClinicalTrials.gov Identifier: NCT04811651    
Other Study ID Numbers: k(2019)46
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hui-Sheng Chen, General Hospital of Shenyang Military Region:
Ischemic Stroke
Stem Cell
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis