Clinical trial NCT05850208: 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
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Ischemic Stroke
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
First posted: 2023-05-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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: 1. 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.
2. 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;

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Definite cerebral infarction in the blood supply area of middle cerebral artery confirmed by imaging;
3. There are clear neurological deficits, such as motor and cognitive dysfunction (National Institutes of Health Stroke Scale 7 \< NIHSS \< 21 points);
4. Those who agree to take effective contraceptive measures during the study period, and women of childbearing age have negative pregnancy test;
5. 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:

1. Lacunar cerebral infarction;
2. Acute cerebral infarction, onset time \< 2 weeks;
3. Mild ischemic stroke or mild neurological impairment or severe ischemic stroke, with coma;
4. Patients with moyamoya disease, vascular malformation, hemangioma and carotid stenosis exceeding 70%;
5. Patients with severe heart valve disease or confirmed intractable atrial fibrillation;
6. Complicated with intracranial hemorrhage or tumor;
7. Patients with cerebral infarction caused by blood system diseases, or those with previous blood history or family history of blood diseases;
8. 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;
9. Those with severe respiratory or circulatory system or liver and kidney dysfunction who cannot tolerate treatment and examination;
10. Severe febrile disease or viral disease in the past 12 weeks;
11. Malignant tumor;
12. Those who have a previous history of autoimmune diseases or a family history of autoimmune diseases;
13. Previous history of drug allergy;
14. Pregnant or lactating women;
15. Those who are participating or have participated in this study or participated in other clinical trials within 12 weeks before enrollment;
16. Other circumstances that the investigator considers inappropriate for participation in this study.

Primary outcomes:
measure: The difference in National Institutes of Health Stroke Scale (NIHSS) score from baseline after the first transplant.
timeFrame: 96 weeks ±30 days after the first transplantation
Secondary outcomes:
measure: The difference from baseline in National Institutes of Health Stroke Scale (NIHSS) score after the first transplantation
timeFrame: 48 weeks ±15 days after the first transplantation
measure: Improvement rate of the modified Barthel Index Rating Scale score from baseline after the first transplant
timeFrame: 48 weeks ±15 days after the first transplantation
measure: Improvement rate of the modified Barthel Index Rating Scale score from baseline
timeFrame: 96 weeks ±30 days after the first transplantation
measure: Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation
timeFrame: 48 weeks ±15 days after the first transplantation
measure: Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation
timeFrame: 96 weeks ±30 days after the first transplantation
measure: Improvement rate of Simple Mental State Examination Scale (MMSE) score
timeFrame: 48 weeks ±15 days after the first transplantation
measure: Improvement rate of Simple Mental State Examination Scale (MMSE) score
timeFrame: 96 weeks ±30 days after the first transplantation
measure: 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
timeFrame: 48 weeks ±15 days after the first transplantation
measure: 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
timeFrame: 96 weeks ±30 days after the first transplantation
measure: 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
timeFrame: 48 weeks ±15 days after the first transplantation
measure: 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
timeFrame: 96 weeks ±30 days after the first transplantation
measure: 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
timeFrame: 48 weeks ±15 days after the first transplantation
measure: 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
timeFrame: 96 weeks ±30 days after the first transplantation
measure: 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
timeFrame: 48 weeks ±15 days after the first transplantation
measure: 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
timeFrame: 96 weeks ±30 days after the first transplantation
measure: Changes in CTA from baseline after the first transplantation
timeFrame: 48 weeks ±15 days after the first transplantation
measure: Changes in CTA from baseline after the first transplantation
timeFrame: 96 weeks ±30 days after the first transplantation
measure: Changes in CTP from baseline after the first transplantation
timeFrame: 96 weeks ±30 days after the first transplantation
measure: Changes in CTP from baseline after the first transplantation
timeFrame: 48 weeks ±15 days after the first transplantation
measure: Changes in mRS Scores from baseline after the first transplantation
timeFrame: 48 weeks ±15 days after the first transplantation
measure: Changes in mRS Scores from baseline after the first transplantation
timeFrame: 96 weeks ±30 days after the first transplantation
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
Study officials:
References: