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

April 16, 2023 updated by: Shanghai East Hospital

Effect of Human Umbilical Cord Mesenchymal Stem Cells(MSCs) Transplantation for on Prognosis of Acute Cerebral Infarction Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Lian Zuo, Doctor
  • Phone Number: 0086-021-38804518-22106
  • Email: mizzmy@163.com

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200123
        • Recruiting
        • Gang Li
        • Contact:
          • Gang Li, Doctor
          • Phone Number: 0086-021-38804518-22106

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months post transplantation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months post transplantation
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.
3 months post transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai East Hospital

Investigators

  • Principal Investigator: Gang Li, Doctor, Shanghai East Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2019

Primary Completion (Anticipated)

December 30, 2024

Study Completion (Anticipated)

December 30, 2024

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 17, 2019

First Posted (Actual)

September 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-DFSC-002（V3）

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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