Back to resultsAutologous Bone Marrow Mesenchymal Stem Cells (BMSCs) Transplantation in the Treatment of Ischemic Stroke
Primary Purpose
Ischemic Stroke
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Transplantation of self BMSCs
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Stroke
Eligibility Criteria
Inclusion Criteria: Patients aged 18-65 years old in the rehabilitation period of cerebral infarction (including subacute stage, chronic stage and sequelae stage, with onset time ≤ 3 years), regardless of gender; Definite cerebral infarction in the blood supply area of middle cerebral artery confirmed by imaging; There are clear neurological deficits, such as motor and cognitive dysfunction (National Institutes of Health Stroke Scale 7 < NIHSS < 21 points); Those who agree to take effective contraceptive measures during the study period, and women of childbearing age have negative pregnancy test; Sign the informed consent of the patient and agree to participate in all visits, examinations and treatments as required by the study protocol. Exclusion Criteria: Lacunar cerebral infarction; Acute cerebral infarction, onset time < 2 weeks; Mild ischemic stroke or mild neurological impairment or severe ischemic stroke, with coma; Patients with moyamoya disease, vascular malformation, hemangioma and carotid stenosis exceeding 70%; Patients with severe heart valve disease or confirmed intractable atrial fibrillation; Complicated with intracranial hemorrhage or tumor; Patients with cerebral infarction caused by blood system diseases, or those with previous blood history or family history of blood diseases; Any one of 5 items of hepatitis B virus (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and syphilis spiral physical examination; Those with severe respiratory or circulatory system or liver and kidney dysfunction who cannot tolerate treatment and examination; Severe febrile disease or viral disease in the past 12 weeks; Malignant tumor; Those who have a previous history of autoimmune diseases or a family history of autoimmune diseases; Previous history of drug allergy; Pregnant or lactating women; Those who are participating or have participated in this study or participated in other clinical trials within 12 weeks before enrollment; Other circumstances that the investigator considers inappropriate for participation in this study.
Sites / Locations
- Zhujiang Hospital of Southern Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine treatment group
BMSCs group
Arm Description
No special measures were taken and routine treatment was adopted
BMSCs were transplanted on the basis of routine treatment: the transplanted cells were injected intravenously and transplanted in two times at a dose of 1 × 106/kg body weight, each volume was 80ml ± 5ml, and the time interval between two transplants was 1 week
Outcomes
Primary Outcome Measures
The difference in National Institutes of Health Stroke Scale (NIHSS) score from baseline after the first transplant.
The difference in National Institutes of Health Stroke Scale (NIHSS) score from baseline at week 96 ±30 days after the first transplant.
Secondary Outcome Measures
The difference from baseline in National Institutes of Health Stroke Scale (NIHSS) score after the first transplantation
The difference from baseline in National Institutes of Health Stroke Scale (NIHSS) score at 48 weeks ±15 days after the first transplantation
Improvement rate of the modified Barthel Index Rating Scale score from baseline after the first transplant
Improvement rate of the modified Barthel Index Rating Scale score from baseline at 48 weeks ±15 days after the first transplantation
Improvement rate of the modified Barthel Index Rating Scale score from baseline
Improvement rate of the modified Barthel Index Rating Scale score from baseline at 96 weeks ±30 days after the first transplant
Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation
Improvement rate of Fugl-Meyer scale score from baseline at 48 weeks ±15 days after the first transplantation
Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation
Improvement rate of Fugl-Meyer scale score from baseline at 96 weeks ±30 days after the first transplantation
Improvement rate of Simple Mental State Examination Scale (MMSE) score
Improvement rate of Simple Mental State Examination Scale (MMSE) score from baseline at 48 weeks ±15 days after the first transplantation
Improvement rate of Simple Mental State Examination Scale (MMSE) score
Improvement rate of Simple Mental State Examination Scale (MMSE) score from baseline at 96 weeks ±30 days after the first transplantation
The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline after the first transplantation
The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline at 48 weeks ±15 days after the first transplantation
The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline after the first transplantation
The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline at 96 weeks ±30 days after the first transplantation
MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential after the first transplantation
MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential at 48 weeks ±15 days after the first transplantation
MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential after the first transplantation
MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential at 96 weeks ±30 days after the first transplantation
The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline after the first transplantation
The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline at 48 weeks ±15 days after the first transplantation
The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline after the first transplantation
The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline at 96 weeks ±30 days after the first transplantation
Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) after the first transplantation
Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) at 48 weeks ±15 days after the first transplantation
Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) after the first transplantation
Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) at 96 weeks ±30 days after the first transplantation
Changes in CTA from baseline after the first transplantation
Changes in CTA from baseline at 48 weeks ±15 days after the first transplantation
Changes in CTA from baseline after the first transplantation
Changes in CTA from baseline at 96 weeks ±30 days after the first transplantation
Changes in CTP from baseline after the first transplantation
Changes in CTP from baseline at 96 weeks ±30 days after the first transplantation
Changes in CTP from baseline after the first transplantation
Changes in CTP from baseline at 48 weeks ±15 days after the first transplantation
Changes in mRS Scores from baseline after the first transplantation
Changes in mRS Scores from baseline at 48 weeks ±15 days after the first transplantation
Changes in mRS Scores from baseline after the first transplantation
Changes in mRS Scores from baseline at 96 weeks ±30 days after the first transplantation
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05850208
Brief Title
Autologous Bone Marrow Mesenchymal Stem Cells (BMSCs) Transplantation in the Treatment of Ischemic Stroke
Official Title
A Randomized, Open and Routine Parallel Controlled Clinical Study on the Safety and Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells (BMSCs) Transplantation in the Treatment of Ischemic Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 23, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhujiang Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This study is to evaluated the safety and efficacy of BMSCs transplantation in the treatment of ischemic stroke, so as to provide a basis for future clinical application of BMSCs transplantation in the treatment of ischemic stroke.
Detailed Description
Routine treatment:
1.1. If arterial plaque is found, use lipid-lowering therapy (routine dose of atorvastatin or rosuvastatin). If no plaque is found, use atorvastatin or rosuvastatin based on the maintenance of normal blood lipid;
1.2. If venous thrombosis or arterial plaques are found in the lower limbs, use dabigatran to prevent platelet aggregation; if no vascular problems are found in the lower limbs, use aspirin or clopidogrel to prevent platelet aggregation;
1.3. During the treatment, cerebrovascular stenosis (non responsible vessels) can be treated intravascularly;
1.4. The use of neurotrophic drugs is prohibited during the study;
1.5. Elevated homocysteine was treated with mecobalamin and folic acid;
1.6. Hypertension, diabetes and other basic diseases receive routine treatment, and the combined medication is recorded in the case report form.
Grouping:
2.1. BMSCs group: BMSCs were transplanted on the basis of routine treatment: the transplanted cells were injected intravenously and transplanted in two times, with a dose of 1 × 106 / kg body weight, each volume of 80ml ± 5ml, and the time interval between two transplants was 1 week;
2.2. Routine treatment group: only receiving routine treatment;
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine treatment group
Arm Type
No Intervention
Arm Description
No special measures were taken and routine treatment was adopted
Arm Title
BMSCs group
Arm Type
Experimental
Arm Description
BMSCs were transplanted on the basis of routine treatment: the transplanted cells were injected intravenously and transplanted in two times at a dose of 1 × 106/kg body weight, each volume was 80ml ± 5ml, and the time interval between two transplants was 1 week
Intervention Type
Biological
Intervention Name(s)
Transplantation of self BMSCs
Intervention Description
Bone marrow was collected, cultured in vitro and injected back into the body
Primary Outcome Measure Information:
Title
The difference in National Institutes of Health Stroke Scale (NIHSS) score from baseline after the first transplant.
Description
The difference in National Institutes of Health Stroke Scale (NIHSS) score from baseline at week 96 ±30 days after the first transplant.
Time Frame
96 weeks ±30 days after the first transplantation
Secondary Outcome Measure Information:
Title
The difference from baseline in National Institutes of Health Stroke Scale (NIHSS) score after the first transplantation
Description
The difference from baseline in National Institutes of Health Stroke Scale (NIHSS) score at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
Improvement rate of the modified Barthel Index Rating Scale score from baseline after the first transplant
Description
Improvement rate of the modified Barthel Index Rating Scale score from baseline at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
Improvement rate of the modified Barthel Index Rating Scale score from baseline
Description
Improvement rate of the modified Barthel Index Rating Scale score from baseline at 96 weeks ±30 days after the first transplant
Time Frame
96 weeks ±30 days after the first transplantation
Title
Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation
Description
Improvement rate of Fugl-Meyer scale score from baseline at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation
Description
Improvement rate of Fugl-Meyer scale score from baseline at 96 weeks ±30 days after the first transplantation
Time Frame
96 weeks ±30 days after the first transplantation
Title
Improvement rate of Simple Mental State Examination Scale (MMSE) score
Description
Improvement rate of Simple Mental State Examination Scale (MMSE) score from baseline at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
Improvement rate of Simple Mental State Examination Scale (MMSE) score
Description
Improvement rate of Simple Mental State Examination Scale (MMSE) score from baseline at 96 weeks ±30 days after the first transplantation
Time Frame
96 weeks ±30 days after the first transplantation
Title
The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline after the first transplantation
Description
The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline after the first transplantation
Description
The time course of the left abductor pollicis brevis and right abductor pollicis brevis of the motor evoked potential decreased from baseline at 96 weeks ±30 days after the first transplantation
Time Frame
96 weeks ±30 days after the first transplantation
Title
MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential after the first transplantation
Description
MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential after the first transplantation
Description
MT increase rate from baseline in the left abductor Pollicis brevis and right abductor pollicis brevis of the motor evoked potential at 96 weeks ±30 days after the first transplantation
Time Frame
96 weeks ±30 days after the first transplantation
Title
The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline after the first transplantation
Description
The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline after the first transplantation
Description
The time course of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) decreased from baseline at 96 weeks ±30 days after the first transplantation
Time Frame
96 weeks ±30 days after the first transplantation
Title
Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) after the first transplantation
Description
Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) after the first transplantation
Description
Rate of increase from baseline amplitude of the upper limb sensory evoked potential N9(left), N11(left), N20(left), N9(right), N11(right), N20(right) at 96 weeks ±30 days after the first transplantation
Time Frame
96 weeks ±30 days after the first transplantation
Title
Changes in CTA from baseline after the first transplantation
Description
Changes in CTA from baseline at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
Changes in CTA from baseline after the first transplantation
Description
Changes in CTA from baseline at 96 weeks ±30 days after the first transplantation
Time Frame
96 weeks ±30 days after the first transplantation
Title
Changes in CTP from baseline after the first transplantation
Description
Changes in CTP from baseline at 96 weeks ±30 days after the first transplantation
Time Frame
96 weeks ±30 days after the first transplantation
Title
Changes in CTP from baseline after the first transplantation
Description
Changes in CTP from baseline at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
Changes in mRS Scores from baseline after the first transplantation
Description
Changes in mRS Scores from baseline at 48 weeks ±15 days after the first transplantation
Time Frame
48 weeks ±15 days after the first transplantation
Title
Changes in mRS Scores from baseline after the first transplantation
Description
Changes in mRS Scores from baseline at 96 weeks ±30 days after the first transplantation
Time Frame
96 weeks ±30 days after the first transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18-65 years old in the rehabilitation period of cerebral infarction (including subacute stage, chronic stage and sequelae stage, with onset time ≤ 3 years), regardless of gender;
Definite cerebral infarction in the blood supply area of middle cerebral artery confirmed by imaging;
There are clear neurological deficits, such as motor and cognitive dysfunction (National Institutes of Health Stroke Scale 7 < NIHSS < 21 points);
Those who agree to take effective contraceptive measures during the study period, and women of childbearing age have negative pregnancy test;
Sign the informed consent of the patient and agree to participate in all visits, examinations and treatments as required by the study protocol.
Exclusion Criteria:
Lacunar cerebral infarction;
Acute cerebral infarction, onset time < 2 weeks;
Mild ischemic stroke or mild neurological impairment or severe ischemic stroke, with coma;
Patients with moyamoya disease, vascular malformation, hemangioma and carotid stenosis exceeding 70%;
Patients with severe heart valve disease or confirmed intractable atrial fibrillation;
Complicated with intracranial hemorrhage or tumor;
Patients with cerebral infarction caused by blood system diseases, or those with previous blood history or family history of blood diseases;
Any one of 5 items of hepatitis B virus (HBsAg, HBsAb, HBeAg, HBeAb, HBcAb), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and syphilis spiral physical examination;
Those with severe respiratory or circulatory system or liver and kidney dysfunction who cannot tolerate treatment and examination;
Severe febrile disease or viral disease in the past 12 weeks;
Malignant tumor;
Those who have a previous history of autoimmune diseases or a family history of autoimmune diseases;
Previous history of drug allergy;
Pregnant or lactating women;
Those who are participating or have participated in this study or participated in other clinical trials within 12 weeks before enrollment;
Other circumstances that the investigator considers inappropriate for participation in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiang Xiaodan
Phone
18680288751
Email
jiangxd@smu.edu.cn
Facility Information:
Facility Name
Zhujiang Hospital of Southern Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510220
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Xiao dan
Phone
18680288751
Email
jiangxd@smu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not yet determined
Learn more about this trial
Autologous Bone Marrow Mesenchymal Stem Cells (BMSCs) Transplantation in the Treatment of Ischemic Stroke
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