Ischemic StrokePhase 1NCT05850208
Autologous Bone Marrow Mesenchymal Stem Cells (BMSCs) Transplantation in the Treatment of Ischemic Stroke
A Phase 1 study testing Transplantation of self BMSCs in people with Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Transplantation of self BMSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 23 Feb 2022to 31 Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 16Show fewer
- 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;
- Other circumstances that the investigator considers inappropriate for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510220
Jiang Xiao dan, 18680288751, jiangxd@smu.edu.cn
About this study
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
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.
Read the detailed description
- 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.
- 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
- Being tested
- Transplantation of self BMSCs
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transplantation of self BMSCsBiological
Bone marrow was collected, cultured in vitro and injected back into the body
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Transplantation of self BMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The difference from baseline in National Institutes of Health Stroke Scale (NIHSS) score at 48 weeks ±15 days after the first transplantation
Measured: 48 weeks ±15 days after the first transplantation
Improvement rate of the modified Barthel Index Rating Scale score from baseline after the first transplant
Improvement rate of the modified Barthel Index Rating Scale score from baseline at 48 weeks ±15 days after the first transplantation
Measured: 48 weeks ±15 days after the first transplantation
Improvement rate of the modified Barthel Index Rating Scale score from baseline
Improvement rate of the modified Barthel Index Rating Scale score from baseline at 96 weeks ±30 days after the first transplant
Measured: 96 weeks ±30 days after the first transplantation
Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation
Improvement rate of Fugl-Meyer scale score from baseline at 48 weeks ±15 days after the first transplantation
Measured: 48 weeks ±15 days after the first transplantation
Improvement rate of Fugl-Meyer scale score from baseline after the first transplantation
Improvement rate of Fugl-Meyer scale score from baseline at 96 weeks ±30 days after the first transplantation
Measured: 96 weeks ±30 days after the first transplantation
Improvement rate of Simple Mental State Examination Scale (MMSE) score
Improvement rate of Simple Mental State Examination Scale (MMSE) score from baseline at 48 weeks ±15 days after the first transplantation
Measured: 48 weeks ±15 days after the first transplantation
Improvement rate of Simple Mental State Examination Scale (MMSE) score
Improvement rate of Simple Mental State Examination Scale (MMSE) score from baseline at 96 weeks ±30 days after the first transplantation
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 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
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
Measured: 96 weeks ±30 days after the first transplantation
Changes in CTA from baseline after the first transplantation
Changes in CTA from baseline at 48 weeks ±15 days after the first transplantation
Measured: 48 weeks ±15 days after the first transplantation
Changes in CTA from baseline after the first transplantation
Changes in CTA from baseline at 96 weeks ±30 days after the first transplantation
Measured: 96 weeks ±30 days after the first transplantation
Changes in CTP from baseline after the first transplantation
Changes in CTP from baseline at 96 weeks ±30 days after the first transplantation
Measured: 96 weeks ±30 days after the first transplantation
Changes in CTP from baseline after the first transplantation
Changes in CTP from baseline at 48 weeks ±15 days after the first transplantation
Measured: 48 weeks ±15 days after the first transplantation
Changes in mRS Scores from baseline after the first transplantation
Changes in mRS Scores from baseline at 48 weeks ±15 days after the first transplantation
Measured: 48 weeks ±15 days after the first transplantation
Changes in mRS Scores from baseline after the first transplantation
Changes in mRS Scores from baseline at 96 weeks ±30 days after the first transplantation
Measured: 96 weeks ±30 days after the first transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start23 Feb 2022
- Primary completion30 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05850208
- Sponsor's protocol ID
- ZJYY.ZTGSJCZGXB-HBT-V2.3-CTP
- Status last verified
- Apr 2023
- First submitted
- 24 Aug 2022
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet determined
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05850208
- Acronym / sponsor ID
- ZJYY.ZTGSJCZGXB-HBT-V2.3-CTP
- Conditions
- Ischemic Stroke
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Study start
- 23 Feb 2022 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine treatment group | No intervention | –No special measures were taken and routine treatment was adopted |
| BMSCs group | Experimental | Biological: Transplantation of self BMSCsBMSCs 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transplantation of self BMSCsBone marrow was collected, cultured in vitro and injected back into the body | Biological | BMSCs group |
Primary outcome
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.
21 secondary outcomes
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
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
Time frame: 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 after the first transplantation
Time frame: 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
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 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 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 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 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 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 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) 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) after the first transplantation
Time frame: 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 after the first transplantation
Time frame: 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 after the first transplantation
Time frame: 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 after the first transplantation
Time frame: 96 weeks ±30 days after the first transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: Undecided. Not yet determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Transplantation of self BMSCs in people with Ischemic Stroke, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Xiaodan (18680288751, jiangxd@smu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.