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

NCT05850208 | Unknown Phase 1

• 1 other identifier: ZJYY.ZTGSJCZGXB-HBT-V2.3-CTP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• 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.

  96 weeks ±30 days after the first transplantation

Secondary Outcomes (21)

• 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

• 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

  96 weeks ±30 days after the first transplantation

• Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation

  48 weeks ±15 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

Study Arms (2)

Routine treatment group

NO INTERVENTION

No special measures were taken and routine treatment was adopted

BMSCs group

EXPERIMENTAL

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

Biological: Transplantation of self BMSCs

Interventions

Transplantation of self BMSCs BIOLOGICAL

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

BMSCs group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, 510220, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Jiang Xiaodan

CONTACT

18680288751; jiangxd@smu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2022
• First Posted: May 9, 2023
• Study Start: February 23, 2022
• Primary Completion: November 30, 2024
• Study Completion: December 31, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-04

Locations

CN (1)