Myocardial InfarctionPhase 2/3BmmsctNCT04421274
Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction
A Phase 2/3 study testing Bone marrow mesenchymal stem cells transfer, Best medical treatment and Percutaneous coronary intervention in people with Myocardial Infarction, run by Affiliated Hospital of North Sichuan Medical College at 1 site in China.
Trial summary
To investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction（ STEMI） . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Bone marrow mesenchymal stem cells transfer, Best medical treatment and Percutaneous coronary intervention
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2008to 15 Jul 2011
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age> 18 years old;
- Diagnosed acute ST-elevation myocardial infarction (STEMI)
- STEMI onset <1 month
- Successful vascular remodeling, blood flow of infarct-related blood vessels recovered to TIMI level 3
- All patients included in the study signed an informed consent form and promised to complete all follow-up plans
Who cannot join
- Refractory persistent ventricular tachycardia
- High cardiac block and no pacemaker control
- Liver or renal dysfunction (ALT>80U/ L, Cr> 440mmol / L)
- Bleeding disorders, malignant tumors
- Autoimmune disease or any serious fatal disease
- Contraindications for coronary intervention
- Combined with other heart disease: congenital heart Disease (ventricular deficiency, atrial deficient, patent ductus arteriosus and other congenital alformations),primary valvular disease, active myocarditis, pulmonary heart disease,hyperthyroidism, mucous edema heart disease and so on
- Mental illness, no self-awareness, and no precise expression and cooperation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction: Single-blind, Randomized Controlled Muticentre Trial
To investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction（ STEMI） .
Read the detailed description
To investigate the safety of intra-coronary injection of autologous bone marrow mesenchymal stem cells (BM-MSCs) in patients with ST-segment elevation myocardial infarction and its effect on cardiac function and viable myocardium. We plan to include approximately 40 patients with ST-segment elevation myocardial infarction as a research object, and conduct a randomized, single-blind, parallel-controlled multi-center clinical trial. The patients were randomly divided into a BM-MSCs group and a control group, and were given the best drug treatment and percutaneous coronary intervention (PCI). The primary study endpoint was the change in myocardial metabolic activity 6 months after autologous BM-MSCs transplantation and the change in left ventricular ejection fraction (LVEF) at 12 months; The incidence of adverse events. The above indexes were evaluated by cardiac color echocardiography and single photon emission computed tomography (SPECT).
- Conditions
- Myocardial Infarction
- Being tested
- Bone marrow mesenchymal stem cells transfer, Best medical treatment, Percutaneous coronary intervention
- Keywords
- Myocardial infarction, Mesenchymal stem cells, Bone marrow, Stem cells transplantation
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bone marrow mesenchymal stem cells transferBiological
Inject the BM-MSCs into the infarct-related arterial hypertension through the central cavity of the guide wire balloon catheter under the complete blockage of the target blood vessel. Each time the balloon continues to fill for 2 minutes to block blood flow, then resume perfusion for 2 minutes. The above process is repeated 6 ~ 8 times
Best medical treatmentDrug
Refer to the latest medication guidelines and give the best medication to the patients
Percutaneous coronary interventionProcedure or surgery
Percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| BM-MSCs group | Experimental | Receive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery ) Receives: Biological: Bone marrow mesenchymal stem cells transfer; Drug: Best medical treatment; Procedure: Percutaneous coronary intervention |
| Control group | Sham comparator | Receive the best medication, percutaneous coronary intervention Receives: Drug: Best medical treatment; Procedure: Percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in myocardial metabolic activity
changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)
Measured: Baseline + after 6 months
Changes in left ventricular ejection fraction (LVEF)
Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.
Measured: Baseline + after 12 months
Secondary outcomes (3)
incidence of cardiovascular events
incidence of cardiovascular events
Measured: in 12 months after transplantation of autologous BM-MSCs
overall mortality
overall mortality
Measured: in 12 months after transplantation of autologous BM-MSCs
adverse events at 12 months after transplantation of autologous BM-MSCs
adverse events at 12 months after transplantation of autologous BM-MSCs
Measured: in 12 months after transplantation of autologous BM-MSCs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 May 2008
- Primary completion10 Jul 2010
- Study completion15 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of North Sichuan Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Chinese PLA General Hospital, Peking Union Medical College Hospital, Beijing Tongren Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04421274
- Sponsor's protocol ID
- ScPHFPC-100306
- Acronym
- Bmmsct
- Status last verified
- Jun 2020
- First submitted
- 14 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Unfortunately, the research data is not shared
Publications
Zhang R, Yu J, Zhang N, Li W, Wang J, Cai G, Chen Y, Yang Y, Liu Z. Bone marrow mesenchymal stem cells transfer in patients with ST-segment elevation myocardial infarction: single-blind, multicenter, randomized controlled trial. Stem Cell Res Ther. 2021 Jan 7;12(1):33. doi: 10.1186/s13287-020-02096-6.
PubMed 33413636
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bone Marrow Mesenchymal Stem Cells Transfer in Patients With ST-segment Elevation Myocardial Infarction: Single-blind, Randomized Controlled Muticentre Trial
- ClinicalTrials.gov ID
- NCT04421274
- Acronym / sponsor ID
- Bmmsct / ScPHFPC-100306
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial infarction, Mesenchymal stem cells, Bone marrow, Stem cells transplantation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Affiliated Hospital of North Sichuan Medical CollegeUniversity, hospital or other
- Collaborators
- Chinese PLA General Hospital, Peking Union Medical College Hospital, Beijing Tongren Hospital
- Study start
- 1 May 2008 (actual)
- Primary completion
- 10 Jul 2010 (actual)
- Study completion
- 15 Jul 2011 (actual)
- First posted
- 9 Jun 2020 (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.
To investigate the effect and safety of intracoronary autologous bone morrow mesenchymal stem cells (BM-MSCs) transplantation in patients with ST-segment elevation myocardial infarction（ STEMI） .
Detailed description
To investigate the safety of intra-coronary injection of autologous bone marrow mesenchymal stem cells (BM-MSCs) in patients with ST-segment elevation myocardial infarction and its effect on cardiac function and viable myocardium. We plan to include approximately 40 patients with ST-segment elevation myocardial infarction as a research object, and conduct a randomized, single-blind, parallel-controlled multi-center clinical trial. The patients were randomly divided into a BM-MSCs group and a control group, and were given the best drug treatment and percutaneous coronary intervention (PCI). The primary study endpoint was the change in myocardial metabolic activity 6 months after autologous BM-MSCs transplantation and the change in left ventricular ejection fraction (LVEF) at 12 months; The incidence of adverse events. The above indexes were evaluated by cardiac color echocardiography and single photon emission computed tomography (SPECT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BM-MSCs group | Experimental | Biological: Bone marrow mesenchymal stem cells transfer, Drug: Best medical treatment, Procedure: Percutaneous coronary interventionReceive the best medication, percutaneous coronary intervention, and bone marrow mesenchymal stem cells transfer(Intracoronary artery ) |
| Control group | Sham comparator | Drug: Best medical treatment, Procedure: Percutaneous coronary interventionReceive the best medication, percutaneous coronary intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age> 18 years old;
- Diagnosed acute ST-elevation myocardial infarction (STEMI)
- STEMI onset <1 month
- Successful vascular remodeling, blood flow of infarct-related blood vessels recovered to TIMI level 3
- All patients included in the study signed an informed consent form and promised to complete all follow-up plans
Key exclusion criteria (8 listed)
- Refractory persistent ventricular tachycardia
- High cardiac block and no pacemaker control
- Liver or renal dysfunction (ALT>80U/ L, Cr> 440mmol / L)
- Bleeding disorders, malignant tumors
- Autoimmune disease or any serious fatal disease
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 |
|---|---|---|
| Bone marrow mesenchymal stem cells transferInject the BM-MSCs into the infarct-related arterial hypertension through the central cavity of the guide wire balloon catheter under the complete blockage of the target blood vessel. Each time the balloon continues to fill for 2 minutes to block blood flow, then resume perfusion for 2 minutes. The above process is repeated 6 ~ 8 times | Biological | BM-MSCs group |
| Best medical treatmentRefer to the latest medication guidelines and give the best medication to the patients | Drug | BM-MSCs group, Control group |
| Percutaneous coronary interventionPercutaneous coronary intervention | Procedure or surgery | BM-MSCs group, Control group |
Primary outcome
changes in myocardial metabolic activity
Time frame: Baseline + after 6 months
changes in myocardial metabolic activity 6 months after transplantation of autologous BM-MSCs (SPET assay)
Changes in left ventricular ejection fraction (LVEF)
Time frame: Baseline + after 12 months
Changes in left ventricular ejection fraction (LVEF) at 12 months after transplantation of autologous BM-MSCs.
3 secondary outcomes
incidence of cardiovascular events
Time frame: in 12 months after transplantation of autologous BM-MSCs
overall mortality
Time frame: in 12 months after transplantation of autologous BM-MSCs
adverse events at 12 months after transplantation of autologous BM-MSCs
Time frame: in 12 months after transplantation of autologous BM-MSCs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
- Derived from this study: PubMed 33413636Zhang R, Yu J, Zhang N, Li W, Wang J, Cai G, Chen Y, Yang Y, Liu Z. Bone marrow mesenchymal stem cells transfer in patients with ST-segment elevation myocardial infarction: single-blind, multicenter, randomized controlled trial. Stem Cell Res Ther. 2021 Jan 7;12(1):33. doi: 10.1186/s13287-020-02096-6.
- Individual participant dataSharing planned: No. Unfortunately, the research data is not shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bone marrow mesenchymal stem cells transfer, Best medical treatment and Percutaneous coronary intervention in people with Myocardial Infarction, run by Affiliated Hospital of North Sichuan Medical College 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 8 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: finished, as of the sponsor's last update on 9 Jun 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in myocardial metabolic activity (time frame: Baseline + after 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04421274, which also lists 1 linked publication.
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 Jun 2020.