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Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients

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: NCT04093336
Recruitment Status : Recruiting
First Posted : September 18, 2019
Last Update Posted : October 28, 2021
Sponsor:
Information provided by (Responsible Party):
Shanghai East Hospital

Study Description
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Brief Summary:

This is a placebo controlled, randomized, double blinded study including Phase 1 and Phase 2. Phase I study is a safety assessment and Phase 2 study is incline to assess effectiveness of MSCs. Potential subjects must be screened and consented before enrolled.

The primary objective of this study is to determine the effects of early intravenous infusion of allogeneic human umbilical cord mesenchymal stem cells (HucMSCs or MSCs used in the following section) for patients with acute ischemic stroke. Eligible patients will receive a single dose of MSCs or placebo within 24 hours after stroke. Patients will be followed for 2 years post infusion for safety and efficacy (change in neurological symptoms and quality of life). Assessments will occur during transplantation and at 3,7, 14 days and1,3, 6, 12, 18 and 24 months after infusions of stem cells.


Condition or disease Intervention/treatment Phase
Infarction, Middle Cerebral Artery Infarction, Anterior Cerebral Artery Cerebral Infarction Stroke, Ischemic Acute Stroke Brain Infarction Infarction, PCA Infarction, Posterior Circulation, Brain Biological: human umbilical cord mesenchymal stem cells Biological: Placebo Other: standardized treatment Phase 1 Phase 2

Detailed Description:

In Phase 1 study, the eligible patients of acute cerebral infarction within 7 days after onset will be randomized to MSCs group or control group and receive intravenous MSCs 2 x 10^6/kg or placebo as a single dose, respectively. Each group will enroll 10 patients and patients will be followed for 2 years to observe the adverse events and evaluate the safety of MSCs for acute ischemic stroke patients.

The safety and preliminary effectiveness of MSCs in the treatment of acute cerebral infarction will be summarized after all patients of Phase 1 study were followed for 3 months post infusion, and the report will be submit to the academic committee and the ethics committee to evaluate before approval to begin the Phase 2 study.

In Phase 2 study, 100 patients with acute infarction within 24 hours after onset will be enrolled and randomized to MSCs group or control group. Patients will have baseline laboratory examinations and cerebral image (MRI or CTP). Enrolled patients will receive intravenous infusion of 2*10^6/kg MSCs or placebo for a single dose and follow for 24 months to assess the adverse events, neurological functional recovery and quality of life.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: placebo controlled, randomized, double blinded
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Human Umbilical Cord Mesenchymal Stem Cells(MSCs) Transplantation for on Prognosis of Acute Cerebral Infarction Patients
Actual Study Start Date : January 13, 2019
Estimated Primary Completion Date : April 30, 2024
Estimated Study Completion Date : August 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: MSCs group
The people in this group will receive intravenous MSCs 2 x 10^6/kg as a single dose and standardized treatment of acute ischemic stroke.
 Biological: human umbilical cord mesenchymal stem cells
The MSCs was intravenous transplanted to acute cerebral infarction patients as a single dose.

Other: standardized treatment
standardized treatment
Placebo Comparator: control group
The people in this group will receive placebo and standardized treatment of acute ischemic stroke.
 Biological: Placebo
Placebo

Other: standardized treatment
standardized treatment


Outcome Measures
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Primary Outcome Measures :
  1. adverse events [ Time Frame: 24 months post transplantation ]
    include tumorigenesis, death, pulmonary embolism, allergy, newly cerebrovascular events and other adverse events to evaluate the safety of MSCs for acute ischemic stroke patients


Secondary Outcome Measures :
  1. the National Institutes of Health Stroke Scale (NIHSS) of 3 months [ Time Frame: 3 months post transplantation ]
    The NIHSS neurologic examination includes 15 individual elements that measure motor and sensory function, language and speech production, vision, level of consciousness and attention, and neglect. The scores of each element are summed (range from 0 to 42) to evaluate the severity of neurological deficits. The more higher score means the more severe neurological dysfunction.

  2. the Barthel index (BI) of 3 months [ Time Frame: 3 months post transplantation ]
    The BI (range from 0 to 100) are used to assess the difference of activities of daily living between two groups. the score ≤40 means severe dependence， score 41~60 means moderate dependence, score 61~99 means mild dependence and score 100 means independence.


Eligibility Criteria
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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. Acute ischemic stroke;
  2. Age 18~80y;
  3. 4≤NIHSS score≤18（including limb score≥2）and modified Rankin scale 0-1 before this cerebral ischemic stroke;
  4. patients and their families understand and will cooperate within the whole process of study, and sign informed consent;
  5. any of following items：①acute cerebral infarction confirmed by cerebral CT perfusion or non-contrast computed tomographic scan < 7 days after onset or ②acute cerebral infarction confirmed by cerebral MR image < 7 days after onset

Exclusion Criteria:

  1. accompanied by hematological disease, severe infection, liver dysfunction (ALT>3*ULN), kidney dysfunction (Scr >2*ULN), cardiac dysfunction (NYHA grade III or IV);
  2. Disturbance of consciousness, mental illness, cognitive impairment and other diseases that may affect informed consent and evaluation of study.
  3. Malignancy history or found to associate cancer after this stroke
  4. Pregnant or lactating women, or women have fertility requirements within 2 years;
  5. Accompanied by immunodeficiency diseases or autoimmune diseases;
  6. Life expectancy is less than 2 years;
  7. Participated in other clinical trial within 6 months;
  8. Patients received Chinese traditional medicine after onset of this stroke;
  9. Patients with allergic predisposition;
  10. Mental implantation or other reasons cannot tolerate magnetic resonance imaging;
  11. Cannot follow up regularly or unwilling to sign informed consent;
  12. Other situations not suitable for enrollment judged by the researchers;
Contacts and Locations
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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): NCT04093336


Contacts
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Contact: Gang Li, Doctor 0086-021-38804518-22106 ligang@tongji.edu.cn
Contact: Lian Zuo, Doctor 0086-021-38804518-22106 mizzmy@163.com

Locations
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China, Shanghai
Gang Li Recruiting
Shanghai, Shanghai, China, 200123
Contact: Gang Li, Doctor    0086-021-38804518-22106      
Sponsors and Collaborators
Shanghai East Hospital
Investigators
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Principal Investigator: Gang Li, Doctor Shanghai East Hospital
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Shanghai East Hospital
ClinicalTrials.gov Identifier: NCT04093336    
Other Study ID Numbers: 2018-DFSC-002（V3）
First Posted: September 18, 2019    Key Record Dates
Last Update Posted: October 28, 2021
Last Verified: October 2021
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
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Shanghai East Hospital:
Acute cerebral infarction ,Mesenchymal Stem Cells,prognosis
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Ischemic Stroke
Brain Infarction
Infarction, Middle Cerebral Artery
Infarction, Anterior Cerebral Artery
Infarction, Posterior Cerebral Artery
Infarction
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Ischemia
Pathologic Processes
Necrosis
Brain Ischemia
Cerebral Arterial Diseases
Intracranial Arterial Diseases