Back to resultsEffect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients
Primary Purpose
Infarction, Middle Cerebral Artery, Infarction, Anterior Cerebral Artery, Cerebral Infarction
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
human umbilical cord mesenchymal stem cells
Placebo
standardized treatment
Sponsored by
About this trial
This is an interventional treatment trial for Infarction, Middle Cerebral Artery focused on measuring Acute cerebral infarction ,Mesenchymal Stem Cells,prognosis
Eligibility Criteria
Inclusion Criteria:
- Acute ischemic stroke;
- Age 18~80y;
- 4≤NIHSS score≤18（including limb score≥2）and modified Rankin scale 0-1 before this cerebral ischemic stroke;
- patients and their families understand and will cooperate within the whole process of study, and sign informed consent;
- 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:
- accompanied by hematological disease, severe infection, liver dysfunction (ALT>3*ULN), kidney dysfunction (Scr >2*ULN), cardiac dysfunction (NYHA grade III or IV);
- Disturbance of consciousness, mental illness, cognitive impairment and other diseases that may affect informed consent and evaluation of study.
- Malignancy history or found to associate cancer after this stroke
- Pregnant or lactating women, or women have fertility requirements within 2 years;
- Accompanied by immunodeficiency diseases or autoimmune diseases;
- Life expectancy is less than 2 years;
- Participated in other clinical trial within 6 months;
- Patients received Chinese traditional medicine after onset of this stroke;
- Patients with allergic predisposition;
- Mental implantation or other reasons cannot tolerate magnetic resonance imaging;
- Cannot follow up regularly or unwilling to sign informed consent;
- Other situations not suitable for enrollment judged by the researchers;
Sites / Locations
- Gang LiRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
MSCs group
control group
Arm Description
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.
The people in this group will receive placebo and standardized treatment of acute ischemic stroke.
Outcomes
Primary Outcome Measures
adverse events
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
the National Institutes of Health Stroke Scale (NIHSS) of 3 months
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.
the Barthel index (BI) of 3 months
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.
Full Information
NCT ID
NCT04093336
First Posted
September 16, 2019
Last Updated
April 16, 2023
Sponsor
Shanghai East Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04093336
Brief Title
Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients
Official Title
Effect of Human Umbilical Cord Mesenchymal Stem Cells(MSCs) Transplantation for on Prognosis of Acute Cerebral Infarction Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2019 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai East Hospital
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infarction, Middle Cerebral Artery, Infarction, Anterior Cerebral Artery, Cerebral Infarction, Stroke, Ischemic, Acute Stroke, Brain Infarction, Infarction, PCA, Infarction, Posterior Circulation, Brain
Keywords
Acute cerebral infarction ,Mesenchymal Stem Cells,prognosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
placebo controlled, randomized, double blinded
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MSCs group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
The people in this group will receive placebo and standardized treatment of acute ischemic stroke.
Intervention Type
Biological
Intervention Name(s)
human umbilical cord mesenchymal stem cells
Intervention Description
The MSCs was intravenous transplanted to acute cerebral infarction patients as a single dose.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Other
Intervention Name(s)
standardized treatment
Intervention Description
standardized treatment
Primary Outcome Measure Information:
Title
adverse events
Description
include tumorigenesis, death, pulmonary embolism, allergy, newly cerebrovascular events and other adverse events to evaluate the safety of MSCs for acute ischemic stroke patients
Time Frame
24 months post transplantation
Secondary Outcome Measure Information:
Title
the National Institutes of Health Stroke Scale (NIHSS) of 3 months
Description
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.
Time Frame
3 months post transplantation
Title
the Barthel index (BI) of 3 months
Description
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.
Time Frame
3 months post transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute ischemic stroke;
Age 18~80y;
4≤NIHSS score≤18（including limb score≥2）and modified Rankin scale 0-1 before this cerebral ischemic stroke;
patients and their families understand and will cooperate within the whole process of study, and sign informed consent;
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:
accompanied by hematological disease, severe infection, liver dysfunction (ALT>3*ULN), kidney dysfunction (Scr >2*ULN), cardiac dysfunction (NYHA grade III or IV);
Disturbance of consciousness, mental illness, cognitive impairment and other diseases that may affect informed consent and evaluation of study.
Malignancy history or found to associate cancer after this stroke
Pregnant or lactating women, or women have fertility requirements within 2 years;
Accompanied by immunodeficiency diseases or autoimmune diseases;
Life expectancy is less than 2 years;
Participated in other clinical trial within 6 months;
Patients received Chinese traditional medicine after onset of this stroke;
Patients with allergic predisposition;
Mental implantation or other reasons cannot tolerate magnetic resonance imaging;
Cannot follow up regularly or unwilling to sign informed consent;
Other situations not suitable for enrollment judged by the researchers;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gang Li, Doctor
Phone
0086-021-38804518-22106
Email
ligang@tongji.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Lian Zuo, Doctor
Phone
0086-021-38804518-22106
Email
mizzmy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gang Li, Doctor
Organizational Affiliation
Shanghai East Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gang Li
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200123
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gang Li, Doctor
Phone
0086-021-38804518-22106
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Effect of Mesenchymal Stem Cells(MSCs) Transplantation for Acute Cerebral Infarction Patients
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