Myocardial InfarctionPhase 2/3NCT02425358
Timing for Bone Marrow Mononuclear Cells After Acute Myocardial Infarction
A Phase 2/3 study testing BMC therapy within 24 hours, BMC therapy within 3-7 days and BMC therapy within 7-30 days in people with Myocardial Infarction, run by The First Affiliated Hospital of Dalian Medical University.
Trial summary
Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary intervention (PCI); however, the optimal timing is unknown. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- BMC therapy within 24 hours, BMC therapy within 3-7 days and BMC therapy within 7-30 days
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Aug 2006
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a history of first acute ST-elevation myocardial infarction
- treatment with successful PCI two to twelve hours after symptom onset
- LVEF less than 50% on angiography immediately after emergency PCI or rescue PCI
Who cannot join
- previous Q-wave myocardial infarction
- cardiogenic shock
- severe coexisting conditions such as acute and chronic heart failure, malignant
- arrhythmia, renal failure and severe bleeding that interfered with the ability of the
- patient to comply with the protocol
About this study
Official title: Timing for Intracoronary Administration of Bone Marrow Mononuclear Cells After Acute ST-elevated Myocardial Infarction: a Pilot Study
Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary intervention (PCI); however, the optimal timing is unknown. The present study assessed the therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).
Read the detailed description
On the basis of experimental studies that bone marrow mononuclear cells (BMCs) transfer in the injured tissue can promote regional myocardial perfusion and improved cardiac function, several clinical trials have shown that intracoronary bone marrow mononuclear cell (BMC) transplantation in acute myocardial infarction (AMI) patients several days after myocardial reperfusion is safe and may enhance the improvement of left ventricular ejection fraction (LVEF). The timing of BMC administration, baseline LVEF, dosage of BMC and other factors has been linked to improvement in LVEF after BMC transplantation. In our previous work, we gave BMCs within 24 hours after emergency percutaneous coronary intervention (PCI) and found that it was safe and effective . In addition, there are another report about longer time from symptom onset to BMC infusion (2-4 weeks), which also appeared effective . The timing of intracoronary stem cell administration may have a critical effect on cell engraftment and may be responsible for the various biological and functional responses to therapy. However, few studies have directly addressed the optimal timing of cell injections. Therefore, in this prospective randomized study, BMCs were given at different times (within 24 hours, 3 to 7 days, or 7 to 30 days after reperfusion) to investigate whether the timing of therapy affects the therapeutic response of AMI patients.
- Conditions
- Myocardial Infarction
- Being tested
- BMC therapy within 24 hours, BMC therapy within 3-7 days, BMC therapy within 7-30 days, PCI only
- Keywords
- cell therapy, BMC, timing
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMC therapy within 24 hoursOther
The BMCs were isolated by Ficoll density gradient centrifugation on Lymphocyte Separation Medium. BMCs were infused into IRA at the site of the previous occlusion. This was accomplished with the use of a microtubular. After positioning of the microtubular into the distal segment vessel of the stent position in the infarct-related artery, 15 milliliter of the whole cell suspension was slowly administered via microtubular. The usual time should be over 10min to prevent back-flow and to prolong cellular contact time for cellular migration into the tissue. Patients in BMC therapy group within 24 hours remained in the cath-lab until the entire procedure, including primary PCI and intracoronary BMC infusion, was completed.
BMC therapy within 3-7 daysOther
Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.
BMC therapy within 7-30 daysOther
Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.
PCI onlyOther
The saline was intracoronary infusion with the use of microtubular.
| Study group | Role | What they receive |
|---|---|---|
| BMC therapy within 24 hours | Experimental | Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 24 hours after successful primary PCI. Receives: Other: BMC therapy within 24 hours |
| BMC therapy within 3-7 days | Experimental | Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 3-7days after successful primary PCI. Receives: Other: BMC therapy within 3-7 days |
| BMC therapy within 7-30 days | Experimental | Patients with acute myocardial infarction who receive intracoronary infusion of BMC within 7-30days after successful primary PCI. Receives: Other: BMC therapy within 7-30 days |
| PCI only | Active comparator | Patients with acute myocardial infarction who were performed successful primary PCI. Receives: Other: PCI only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of left ventricular eject factor (LVEF) from the baseline
Measured: 12 months
Secondary outcomes (3)
Change of left ventricular end-diastolic volume (LVESV) from the baseline
Measured: 12 months
Change of left ventricular end-systolic volume (LVEDV) from the baseline
Measured: 12 months
Change of myocardial perfusion from the baseline
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 posted24 Apr 2015 (estimated)
- Study startFeb 2005
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Fudan University
- Responsible party
- Principal investigator, Rchuang, The First Affiliated Hospital of Dalian Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425358
- Sponsor's protocol ID
- 2004BA714B05-2
- Status last verified
- Apr 2015
- First submitted
- 15 Apr 2015
- Last updated
- 24 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Yao K, Huang R, Sun A, Qian J, Liu X, Ge L, Zhang Y, Zhang S, Niu Y, Wang Q, Zou Y, Ge J. Repeated autologous bone marrow mononuclear cell therapy in patients with large myocardial infarction. Eur J Heart Fail. 2009 Jul;11(7):691-8. doi: 10.1093/eurjhf/hfp062. Epub 2009 May 6.
PubMed 19420003Yao K, Huang R, Qian J, Cui J, Ge L, Li Y, Zhang F, Shi H, Huang D, Zhang S, Sun A, Zou Y, Ge J. Administration of intracoronary bone marrow mononuclear cells on chronic myocardial infarction improves diastolic function. Heart. 2008 Sep;94(9):1147-53. doi: 10.1136/hrt.2007.137919. Epub 2008 Apr 1.
PubMed 18381377Huang R, Yao K, Sun A, Qian J, Ge L, Zhang Y, Niu Y, Wang K, Zou Y, Ge J. Timing for intracoronary administration of bone marrow mononuclear cells after acute ST-elevation myocardial infarction: a pilot study. Stem Cell Res Ther. 2015 May 29;6(1):112. doi: 10.1186/s13287-015-0102-5.
PubMed 26021558
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timing for Intracoronary Administration of Bone Marrow Mononuclear Cells After Acute ST-elevated Myocardial Infarction: a Pilot Study
- ClinicalTrials.gov ID
- NCT02425358
- Acronym / sponsor ID
- 2004BA714B05-2
- Conditions
- Myocardial Infarction
- Keywords
- cell therapy, BMC, timing
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Dalian Medical UniversityUniversity, hospital or other
- Collaborators
- Fudan University
- Study start
- Feb 2005
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 24 Apr 2015 (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.
Most studies on intracoronary bone marrow mononuclear cell (BMC) transplantation for acute myocardial infarction (AMI) involve treatment 3-7 days after primary percutaneous coronary intervention (PCI); however, the optimal timing is unknown. The present study assessed the therapeutic effect at different times after ST-elevation myocardial infarction (STEMI).
Detailed description
On the basis of experimental studies that bone marrow mononuclear cells (BMCs) transfer in the injured tissue can promote regional myocardial perfusion and improved cardiac function, several clinical trials have shown that intracoronary bone marrow mononuclear cell (BMC) transplantation in acute myocardial infarction (AMI) patients several days after myocardial reperfusion is safe and may enhance the improvement of left ventricular ejection fraction (LVEF). The timing of BMC administration, baseline LVEF, dosage of BMC and other factors has been linked to improvement in LVEF after BMC transplantation. In our previous work, we gave BMCs within 24 hours after emergency percutaneous coronary intervention (PCI) and found that it was safe and effective . In addition, there are another report about longer time from symptom onset to BMC infusion (2-4 weeks), which also appeared effective . The timing of intracoronary stem cell administration may have a critical effect on cell engraftment and may be responsible for the various biological and functional responses to therapy. However, few studies have directly addressed the optimal timing of cell injections. Therefore, in this prospective randomized study, BMCs were given at different times (within 24 hours, 3 to 7 days, or 7 to 30 days after reperfusion) to investigate whether the timing of therapy affects the therapeutic response of AMI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMC therapy within 24 hours | Experimental | Other: BMC therapy within 24 hoursPatients with acute myocardial infarction who receive intracoronary infusion of BMC within 24 hours after successful primary PCI. |
| BMC therapy within 3-7 days | Experimental | Other: BMC therapy within 3-7 daysPatients with acute myocardial infarction who receive intracoronary infusion of BMC within 3-7days after successful primary PCI. |
| BMC therapy within 7-30 days | Experimental | Other: BMC therapy within 7-30 daysPatients with acute myocardial infarction who receive intracoronary infusion of BMC within 7-30days after successful primary PCI. |
| PCI only | Active comparator | Other: PCI onlyPatients with acute myocardial infarction who were performed successful primary PCI. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- a history of first acute ST-elevation myocardial infarction
- treatment with successful PCI two to twelve hours after symptom onset
- LVEF less than 50% on angiography immediately after emergency PCI or rescue PCI
Key exclusion criteria (5 listed)
- previous Q-wave myocardial infarction
- cardiogenic shock
- severe coexisting conditions such as acute and chronic heart failure, malignant
- arrhythmia, renal failure and severe bleeding that interfered with the ability of the
- patient to comply with the protocol
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 |
|---|---|---|
| BMC therapy within 24 hoursThe BMCs were isolated by Ficoll density gradient centrifugation on Lymphocyte Separation Medium. BMCs were infused into IRA at the site of the previous occlusion. This was accomplished with the use of a microtubular. After positioning of the microtubular into the distal segment vessel of the stent position in the infarct-related artery, 15 milliliter of the whole cell suspension was slowly administered via microtubular. The usual time should be over 10min to prevent back-flow and to prolong cellular contact time for cellular migration into the tissue. Patients in BMC therapy group within 24 hours remained in the cath-lab until the entire procedure, including primary PCI and intracoronary BMC infusion, was completed. | Other | BMC therapy within 24 hours |
| BMC therapy within 3-7 daysPatients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization. | Other | BMC therapy within 3-7 days |
| BMC therapy within 7-30 daysPatients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization. | Other | BMC therapy within 7-30 days |
| PCI onlyThe saline was intracoronary infusion with the use of microtubular. | Other | PCI only |
Primary outcome
Change of left ventricular eject factor (LVEF) from the baseline
Time frame: 12 months
3 secondary outcomes
Change of left ventricular end-diastolic volume (LVESV) from the baseline
Time frame: 12 months
Change of left ventricular end-systolic volume (LVEDV) from the baseline
Time frame: 12 months
Change of myocardial perfusion from the baseline
Time frame: 12 months
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 24 Apr 2015.
- Background: PubMed 19420003Yao K, Huang R, Sun A, Qian J, Liu X, Ge L, Zhang Y, Zhang S, Niu Y, Wang Q, Zou Y, Ge J. Repeated autologous bone marrow mononuclear cell therapy in patients with large myocardial infarction. Eur J Heart Fail. 2009 Jul;11(7):691-8. doi: 10.1093/eurjhf/hfp062. Epub 2009 May 6.
- Background: PubMed 18381377Yao K, Huang R, Qian J, Cui J, Ge L, Li Y, Zhang F, Shi H, Huang D, Zhang S, Sun A, Zou Y, Ge J. Administration of intracoronary bone marrow mononuclear cells on chronic myocardial infarction improves diastolic function. Heart. 2008 Sep;94(9):1147-53. doi: 10.1136/hrt.2007.137919. Epub 2008 Apr 1.
- Derived from this study: PubMed 26021558Huang R, Yao K, Sun A, Qian J, Ge L, Zhang Y, Niu Y, Wang K, Zou Y, Ge J. Timing for intracoronary administration of bone marrow mononuclear cells after acute ST-elevation myocardial infarction: a pilot study. Stem Cell Res Ther. 2015 May 29;6(1):112. doi: 10.1186/s13287-015-0102-5.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BMC therapy within 24 hours, BMC therapy within 3-7 days and BMC therapy within 7-30 days in people with Myocardial Infarction, run by The First Affiliated Hospital of Dalian Medical University.
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 3 inclusion and 5 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 24 Apr 2015. 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. 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?
Change of left ventricular eject factor (LVEF) from the baseline (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 NCT02425358, which also lists 3 linked publications.
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 24 Apr 2015.