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

May 6, 2023 updated by: Zhujiang Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510220
        • Recruiting
        • Zhujiang Hospital of Southern Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Routine treatment group
No special measures were taken and routine treatment was adopted
Experimental: 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
Biological: Transplantation of self BMSCs
Bone marrow was collected, cultured in vitro and injected back into the body

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The difference in National Institutes of Health Stroke Scale (NIHSS) score from baseline after the first transplant.
Time Frame: 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.
96 weeks ±30 days after the first transplantation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The difference from baseline in National Institutes of Health Stroke Scale (NIHSS) score after the first transplantation
Time Frame: 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
48 weeks ±15 days after the first transplantation
Improvement rate of the modified Barthel Index Rating Scale score from baseline after the first transplant
Time Frame: 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
48 weeks ±15 days after the first transplantation
Improvement rate of the modified Barthel Index Rating Scale score from baseline
Time Frame: 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
96 weeks ±30 days after the first transplantation
Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation
Time Frame: 48 weeks ±15 days after the first transplantation
Improvement rate of Fugl-Meyer scale score from baseline at 48 weeks ±15 days 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
Time Frame: 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
96 weeks ±30 days after the first transplantation
Improvement rate of Simple Mental State Examination Scale (MMSE) score
Time Frame: 48 weeks ±15 days after the first transplantation
Improvement rate of Simple Mental State Examination Scale (MMSE) score from baseline at 48 weeks ±15 days after the first transplantation
48 weeks ±15 days after the first transplantation
Improvement rate of Simple Mental State Examination Scale (MMSE) score
Time Frame: 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
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
Time Frame: 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 at 48 weeks ±15 days after the first transplantation
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
Time Frame: 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
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
Time Frame: 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 at 48 weeks ±15 days after the first transplantation
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
Time Frame: 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
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
Time Frame: 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 at 48 weeks ±15 days after the first transplantation
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
Time Frame: 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
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
Time Frame: 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) at 48 weeks ±15 days after the first transplantation
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
Time Frame: 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
96 weeks ±30 days after the first transplantation
Changes in CTA from baseline after the first transplantation
Time Frame: 48 weeks ±15 days after the first transplantation
Changes in CTA from baseline at 48 weeks ±15 days after the first transplantation
48 weeks ±15 days after the first transplantation
Changes in CTA from baseline after the first transplantation
Time Frame: 96 weeks ±30 days after the first transplantation
Changes in CTA from baseline at 96 weeks ±30 days after the first transplantation
96 weeks ±30 days after the first transplantation
Changes in CTP from baseline after the first transplantation
Time Frame: 96 weeks ±30 days after the first transplantation
Changes in CTP from baseline at 96 weeks ±30 days after the first transplantation
96 weeks ±30 days after the first transplantation
Changes in CTP from baseline after the first transplantation
Time Frame: 48 weeks ±15 days after the first transplantation
Changes in CTP from baseline at 48 weeks ±15 days after the first transplantation
48 weeks ±15 days after the first transplantation
Changes in mRS Scores from baseline after the first transplantation
Time Frame: 48 weeks ±15 days after the first transplantation
Changes in mRS Scores from baseline at 48 weeks ±15 days after the first transplantation
48 weeks ±15 days after the first transplantation
Changes in mRS Scores from baseline after the first transplantation
Time Frame: 96 weeks ±30 days after the first transplantation
Changes in mRS Scores from baseline at 96 weeks ±30 days after the first transplantation
96 weeks ±30 days after the first transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zhujiang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 23, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 30, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZJYY.ZTGSJCZGXB-HBT-V2.3-CTP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Not yet determined

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Drug Interventions

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Drug Interventions

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