Myocardial InfarctionPhase 2TEAM-AMINCT03047772
Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in AMI Patients
A Phase 2 study testing Atorvastatin, Intensive Atorvastatin and Low dose BMMSC in people with Myocardial Infarction and Stem Cell Transplantation, run by Yuejin Yang.
Trial summary
The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after acute myocardial infarction who… Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Myocardial Infarction, Stem Cell Transplantation, Angioplasty, Transluminal, Percutaneous Coronary
- What is being tested?
- Atorvastatin, Intensive Atorvastatin and Low dose BMMSC
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- 6 Mar 2018to 31 Dec 2018
- Phase
- Phase 2
- 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 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the first time ST-elevation myocardial infarction (STEMI).
- Patients after undergoing PCI 2 to 5 days.
- Patients without PCI but emergency coronary angiography shows the criminal coronary artery recanalized.
- Left ventricular infarction area seriously hypokinesis or no movement
- Left ventricular ejection fraction <=45% based on coronary angiography or echocardiography.
Who cannot join
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- Patients without emergency PCI and the criminal coronary artery fail to be recanalized.
- Patients with non-ST-elevation myocardial infarction.
- Patients with normal left ventricular function.
- Patients with mechanical complications of myocardial infarction.
- Patients with a malignant tumor.
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- Patients with infection disease.
- Less than 6 months since last episode of stroke.
- Patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
- ALT (GPT) exceeding 100 IU/L.
- Leukocytes less than 4,000/µL or exceeding 10,000/µL.
- Platelets less than 100,000/µL.
- Hemoglobin less than 10 g/dL.
- Pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
- Any other reason that the Clinical Supervisors or Clinical Researchers may have for considering a case unsuitable for the study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Randomized Double-blind Placebo-Controlled Multi-center Clinical Trial of Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in Acute Myocardial Infarction Patients
The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after acute myocardial infarction who underwent intracoronary transfer of autologous bone marrow mesenchymal stem cells.
Read the detailed description
The major challenge to a successful stem cell therapy for myocardial infarction is the low survival rate of implanted cells in the damaged tissue. Atorvastatin, an HMG-CoA reductase inhibitor, has multiple biological activities independent of cholesterol-lowering action.This study is performed to find out more information about the strategy with Atorvastatin therapy to improve the survival of implanted cells, autologous bone marrow mesenchymal stem cells transplantation. Patients between 30 and 75 years of age who receive autologous bone marrow mesenchymal stem cells transplant may be eligible for this study. These patients receive autologous bone marrow mesenchymal stem cells transplantation intracoronary undergoing Percutaneous Coronary Intervention with regular or high dose of Atorvastatin treatment. The objective evaluations will be performed at baseline and during 12 months follow-up.
Heart function tests may include the following:
Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
MRI evaluates function of the heart chambers the beating motion of the muscle.
- Conditions
- Myocardial Infarction, Stem Cell Transplantation, Angioplasty, Transluminal, Percutaneous Coronary
- Being tested
- Atorvastatin, Intensive Atorvastatin, Low dose BMMSC, Middle dose BMMSC, High dose BMMSC
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
Also called Statin
Routine dose of Atorvastatin therapy
Intensive AtorvastatinDrug
Intensive dose of Atorvastatin therapy
Low dose BMMSCDrug
Low dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
Middle dose BMMSCDrug
Middle dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
High dose BMMSCDrug
High dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
TransplantationDrug
Optimal dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
| Study group | Role | What they receive |
|---|---|---|
| Phase A: Atorvastatin | Placebo comparator | Atorvastatin routine dose + placebo transplantation Receives: Drug: Atorvastatin |
| Phase A: Low dose BMMSC | Experimental | Atorvastatin routine dose + low dose BMMSC Transplantation Receives: Drug: Atorvastatin; Drug: Low dose BMMSC |
| Phase A: Middle dose BMMSC | Experimental | Atorvastatin routine dose + middle dose BMMSC Transplantation Receives: Drug: Atorvastatin; Drug: Middle dose BMMSC |
| Phase A: High dose BMMSC | Experimental | Atorvastatin routine dose + high dose BMMSC Transplantation Receives: Drug: Atorvastatin; Drug: High dose BMMSC |
| Phase B: Atorvastatin | Placebo comparator | Atorvastatin routine dose + placebo transplantation Receives: Drug: Atorvastatin |
| Phase B: Atorvastatin+Transplantation | Active comparator | Atorvastatin routine dose+ Optimal dose BMMSC Transplantation Receives: Drug: Atorvastatin; Drug: Transplantation |
| Phase B: Intensive Atorvastatin | Placebo comparator | Atorvastatin Intensive dose + placebo transplantation Receives: Drug: Intensive Atorvastatin |
| Phase B: Intensive Atorvastatin+Transplantation | Experimental | Atorvastatin Intensive dose + Optimal dose BMMSC Transplantation Receives: Drug: Intensive Atorvastatin; Drug: Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in left ventricular ejection fraction from baseline to 12 months'
Changes in left ventricular ejection fraction from baseline to 12 months' by MRI
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start6 Mar 2018 (estimated)
- Primary completion31 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuejin Yang
- Sponsor type
- University, hospital or other
- Collaborators
- Peking Union Medical College Hospital, The First Hospital of Hebei Medical University, Zunyi Medical College
- Responsible party
- Sponsor-investigator, Yuejin Yang, Chinese Academy of Medical Sciences, Fuwai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047772
- Sponsor's protocol ID
- 2016-807-10.1
- Acronym
- TEAM-AMI
- Status last verified
- Jan 2018
- First submitted
- 7 Feb 2017
- Last updated
- 25 Jan 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xu JY, Qian HY, Huang PS, Xu J, Xiong YY, Jiang WY, Xu Y, Leng WX, Li XD, Chen GH, Tang RJ, Huang CR, Hu MJ, Jin C, Wu Y, Zhang J, Qian J, Xu B, Zhao SH, Lu MJ, Shen R, Fang W, Wu WC, Chen X, Wang Y, Li W, Lu XF, Jiang XF, Ma CC, Li JW, Geng YJ, Qiao SB, Gao RL, Yang YJ. Transplantation efficacy of autologous bone marrow mesenchymal stem cells combined with atorvastatin for acute myocardial infarction (TEAM-AMI): rationale and design of a randomized, double-blind, placebo-controlled, multi-center, Phase II TEAM-AMI trial. Regen Med. 2019 Dec;14(12):1077-1087. doi: 10.2217/rme-2019-0024. Epub 2019 Dec 12.
PubMed 31829095
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Randomized Double-blind Placebo-Controlled Multi-center Clinical Trial of Transplantation Efficacy of Autologous Bone Marrow Mesenchymal Stem Cells With Intensive Atorvastatin in Acute Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT03047772
- Acronym / sponsor ID
- TEAM-AMI / 2016-807-10.1
- Conditions
- Myocardial Infarction, Stem Cell Transplantation, Angioplasty, Transluminal, Percutaneous Coronary
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Yuejin YangUniversity, hospital or other
- Collaborators
- Peking Union Medical College Hospital, The First Hospital of Hebei Medical University, Zunyi Medical College
- Study start
- 6 Mar 2018 (estimated)
- Primary completion
- 31 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 9 Feb 2017 (estimated)
- 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.
The benefit of current stem cell transplantation therapy for myocardial infarction is limited by low survival rate for stem cell. The purpose of this study is to test whether intensive Atorvastatin therapy can improve the outcome of patients with impaired left ventricle function after acute myocardial infarction who underwent intracoronary transfer of autologous bone marrow mesenchymal stem cells.
Detailed description
The major challenge to a successful stem cell therapy for myocardial infarction is the low survival rate of implanted cells in the damaged tissue. Atorvastatin, an HMG-CoA reductase inhibitor, has multiple biological activities independent of cholesterol-lowering action.This study is performed to find out more information about the strategy with Atorvastatin therapy to improve the survival of implanted cells, autologous bone marrow mesenchymal stem cells transplantation. Patients between 30 and 75 years of age who receive autologous bone marrow mesenchymal stem cells transplant may be eligible for this study. These patients receive autologous bone marrow mesenchymal stem cells transplantation intracoronary undergoing Percutaneous Coronary Intervention with regular or high dose of Atorvastatin treatment. The objective evaluations will be performed at baseline and during 12 months follow-up.
Heart function tests may include the following:
Electrocardiogram (EKG) evaluates the electrical activity of the heart. Electrodes placed on the chest transmit information from the heart to a machine.
Echocardiogram (Echo) is an ultrasound test that uses sound waves to create an image of the heart and examine the function of the heart chambers and valves.
Gated acquisition scan is a nuclear medicine test that uses a small amount of radioactive chemical injected into a vein. A special scanner creates an image of the heart for examining the beating motion of the muscle.
MRI evaluates function of the heart chambers the beating motion of the muscle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Phase A: Atorvastatin | Placebo comparator | Drug: AtorvastatinAtorvastatin routine dose + placebo transplantation |
| Phase A: Low dose BMMSC | Experimental | Drug: Atorvastatin, Drug: Low dose BMMSCAtorvastatin routine dose + low dose BMMSC Transplantation |
| Phase A: Middle dose BMMSC | Experimental | Drug: Atorvastatin, Drug: Middle dose BMMSCAtorvastatin routine dose + middle dose BMMSC Transplantation |
| Phase A: High dose BMMSC | Experimental | Drug: Atorvastatin, Drug: High dose BMMSCAtorvastatin routine dose + high dose BMMSC Transplantation |
| Phase B: Atorvastatin | Placebo comparator | Drug: AtorvastatinAtorvastatin routine dose + placebo transplantation |
| Phase B: Atorvastatin+Transplantation | Active comparator | Drug: Atorvastatin, Drug: TransplantationAtorvastatin routine dose+ Optimal dose BMMSC Transplantation |
| Phase B: Intensive Atorvastatin | Placebo comparator | Drug: Intensive AtorvastatinAtorvastatin Intensive dose + placebo transplantation |
| Phase B: Intensive Atorvastatin+Transplantation | Experimental | Drug: Intensive Atorvastatin, Drug: TransplantationAtorvastatin Intensive dose + Optimal dose BMMSC Transplantation |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with the first time ST-elevation myocardial infarction (STEMI).
- Patients after undergoing PCI 2 to 5 days.
- Patients without PCI but emergency coronary angiography shows the criminal coronary artery recanalized.
- Left ventricular infarction area seriously hypokinesis or no movement
- Left ventricular ejection fraction <=45% based on coronary angiography or echocardiography.
Key exclusion criteria (15 listed)
- Any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
- Patients without emergency PCI and the criminal coronary artery fail to be recanalized.
- Patients with non-ST-elevation myocardial infarction.
- Patients with normal left ventricular function.
- Patients with mechanical complications of myocardial infarction.
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 |
|---|---|---|
| AtorvastatinAlso: StatinRoutine dose of Atorvastatin therapy | Drug | Phase A: Atorvastatin, Phase A: High dose BMMSC, Phase A: Low dose BMMSC, Phase A: Middle dose BMMSC, Phase B: Atorvastatin, Phase B: Atorvastatin+Transplantation |
| Intensive AtorvastatinIntensive dose of Atorvastatin therapy | Drug | Phase B: Intensive Atorvastatin, Phase B: Intensive Atorvastatin+Transplantation |
| Low dose BMMSCLow dose autologous Bone Marrow Mesenchymal Stem Cells transplantation | Drug | Phase A: Low dose BMMSC |
| Middle dose BMMSCMiddle dose autologous Bone Marrow Mesenchymal Stem Cells transplantation | Drug | Phase A: Middle dose BMMSC |
| High dose BMMSCHigh dose autologous Bone Marrow Mesenchymal Stem Cells transplantation | Drug | Phase A: High dose BMMSC |
| TransplantationOptimal dose autologous Bone Marrow Mesenchymal Stem Cells transplantation | Drug | Phase B: Atorvastatin+Transplantation, Phase B: Intensive Atorvastatin+Transplantation |
Primary outcome
Changes in left ventricular ejection fraction from baseline to 12 months'
Time frame: 12 months
Changes in left ventricular ejection fraction from baseline to 12 months' by MRI
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Derived from this study: PubMed 31829095Xu JY, Qian HY, Huang PS, Xu J, Xiong YY, Jiang WY, Xu Y, Leng WX, Li XD, Chen GH, Tang RJ, Huang CR, Hu MJ, Jin C, Wu Y, Zhang J, Qian J, Xu B, Zhao SH, Lu MJ, Shen R, Fang W, Wu WC, Chen X, Wang Y, Li W, Lu XF, Jiang XF, Ma CC, Li JW, Geng YJ, Qiao SB, Gao RL, Yang YJ. Transplantation efficacy of autologous bone marrow mesenchymal stem cells combined with atorvastatin for acute myocardial infarction (TEAM-AMI): rationale and design of a randomized, double-blind, placebo-controlled, multi-center, Phase II TEAM-AMI trial. Regen Med. 2019 Dec;14(12):1077-1087. doi: 10.2217/rme-2019-0024. Epub 2019 Dec 12.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin, Intensive Atorvastatin and Low dose BMMSC in people with Myocardial Infarction and Stem Cell Transplantation, run by Yuejin Yang.
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 15 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 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
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 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.
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 Haiyan Qian, Doctor (861068314466, ahqhy712@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in left ventricular ejection fraction from baseline to 12 months' (time frame: 12 months). 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 NCT03047772, 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 25 Jan 2018.