Effect of Different Transplantation Time for Mesenchymal Stem Cells(MSCs) of 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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04093336|
Recruitment Status : Enrolling by invitation
First Posted : September 18, 2019
Last Update Posted : February 6, 2020
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 different time points for 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 12 hours or 5-7days 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||Biological: human umbilical cord mesenchymal stem cells Biological: Placebo Other: standardized treatment||Phase 1 Phase 2|
In Phase 1 study, the eligible patients with acute cerebral infarction 5-7 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 12 hours after onset or 5-7 days 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 (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||placebo controlled, randomized, double blinded|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effect of Different Transplantation Time for Human Umbilical Cord Mesenchymal Stem Cells(MSCs) on Prognosis of Acute Cerebral Infarction Patients|
|Actual Study Start Date :||January 13, 2019|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||December 30, 2022|
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
Placebo Comparator: control group
The people in this group will receive placebo and standardized treatment of acute ischemic stroke.
Other: standardized treatment
- 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
- 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.
- 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.
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
|Shanghai, Shanghai, China, 200123|
|Principal Investigator:||Gang Li, Doctor||Shanghai East Hospital|