Autologous Bone Marrow Mesenchymal Stem Cells (BMSCs) Transplantation in the Treatment of Ischemic Stroke

Phase 1

Recruiting

• Conditions: Ischemic Stroke
• Interventions: Biological: Transplantation of self BMSCs

• Registration Number: NCT05850208
• Lead Sponsor: Zhujiang Hospital

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;

Study Timeline

• Study Start: 2022-02-23
• Study First Submitted: 2022-08-24
• Status Verified: 2023-04
• Study First Submitted QC: 2023-05-06
• Last Update Submitted: 2023-05-06
• Study First Posted: 2023-05-09
• Last Update Posted: 2023-05-09
• Primary Completion: 2024-11-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BMSCs group	Transplantation of self BMSCs	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

Primary Outcome Measures

Name	Time	Method
The difference in National Institutes of Health Stroke Scale (NIHSS) score from baseline after the first transplant.	96 weeks ±30 days after the first transplantation	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

Name	Time	Method
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	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 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	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 at 96 weeks ±30 days after the first transplantation
Changes in mRS Scores from baseline after the first transplantation	96 weeks ±30 days after the first transplantation	Changes in mRS Scores from baseline at 96 weeks ±30 days after the first transplantation
Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation	96 weeks ±30 days after the first transplantation	Improvement rate of Fugl-Meyer scale score from baseline at 96 weeks ±30 days after the first transplantation
The difference from baseline in National Institutes of Health Stroke Scale (NIHSS) score after the first transplantation	48 weeks ±15 days 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 Simple Mental State Examination Scale (MMSE) score	96 weeks ±30 days after the first transplantation	Improvement rate of Simple Mental State Examination Scale (MMSE) score from baseline at 96 weeks ±30 days after the first transplantation
Changes in CTA from baseline after the first transplantation	96 weeks ±30 days after the first transplantation	Changes in CTA from baseline at 96 weeks ±30 days after the first transplantation
Improvement rate of the modified Barthel Index Rating Scale score from baseline	96 weeks ±30 days after the first transplantation	Improvement rate of the modified Barthel Index Rating Scale score from baseline at 96 weeks ±30 days after the first transplant
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	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 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	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) at 96 weeks ±30 days after the first transplantation
Improvement rate of the modified Barthel Index Rating Scale score from baseline after the first transplant	48 weeks ±15 days after the first transplantation	Improvement rate of the modified Barthel Index Rating Scale score from baseline at 48 weeks ±15 days after the first transplantation
Changes in CTP from baseline after the first transplantation	48 weeks ±15 days after the first transplantation	Changes in CTP from baseline at 48 weeks ±15 days after the first transplantation

Trial Locations

Locations (1)

Zhujiang Hospital of Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China