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

NCT ID: NCT05850208

Last Updated: 2023-05-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-23
• Study Completion Date: 2024-12-31

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;

Conditions

Ischemic Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Routine treatment group

No special measures were taken and routine treatment was adopted

Group Type: NO_INTERVENTION

No interventions assigned to this group

BMSCs group

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

Group Type: EXPERIMENTAL

Transplantation of self BMSCs

Intervention Type: BIOLOGICAL

Bone marrow was collected, cultured in vitro and injected back into the body

Interventions

Transplantation of self BMSCs

Bone marrow was collected, cultured in vitro and injected back into the body

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhujiang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jiang Xiaodan

Role: CONTACT

jiangxd@smu.edu.cn

18680288751

Facility Contacts

Jiang Xiao dan

Role: primary

jiangxd@smu.edu.cn

18680288751

Other Identifiers

ZJYY.ZTGSJCZGXB-HBT-V2.3-CTP

Identifier Type: -

Identifier Source: org_study_id