Myocardial InfarctionPhase 1/2NCT00626145
Long Term Follow-up of Autologous Bone Marrow Mononuclear Cells Therapy in STEMI
A Phase 1/2 study testing saline infusion and autologous bone marrow mononuclear cells infusion in people with Myocardial Infarction, run by Xijing Hospital at 1 site in China.
Trial summary
The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- saline infusion and autologous bone marrow mononuclear cells infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- Mar 2003to Mar 2008
- Phase
- Phase 1/2
- 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 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ST segment elevation myocardial infarction, according to the WHO definition.
- <24 hour from the origin of symptoms.
- Single left anterior descending coronary artery disease.
- Successful revascularization of culprit lesion with PCI.
- Age between 45 and 65 years old.
- Written informed consent.
Who cannot join
- Previous MI.
- Cardiomyopathy.
- Atrial fibrillation or fluctuation.
- Previous heart surgery.
- Severe valvular heart disease.
- Disease of the hematopoetic system.
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- NYHA functional class IV at baseline.
- Severe renal, lung and liver disease or cancer.
- Significant coronary lesion in one or more major coronary vessels, requiring revascularization.
- Intra-cardiac thrombus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction
The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Our aim was to investigate 4 years' efficacy and LV functional improvement of autologous bone marrow mononuclear cells (BMMC) transplantation in patients with ST-elevation myocardial infarction.
Read the detailed description
The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results.
Aim is to evaluate the long term efficiency of unselected bone marrow mononuclear cells in treatment of patients with ST-elevation myocardial infarction (STEMI), especially with regard to the left ventricular function. The cells are delivered by intracoronary infusion 7 days after the PCI. Outcomes including LVEF, myocardial viability and coronary artery status are assessed by echocardiography, SPECT and coronary angiography.
- Conditions
- Myocardial Infarction
- Being tested
- saline infusion, autologous bone marrow mononuclear cells infusion
- Keywords
- BMMNC, STEMI, stem cell, intracoronary delivery
- Medical subject headings
- Myocardial Infarction, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
saline infusionProcedure or surgery
Also called saline placebo, placebo control
Patients receive intracoronary injections of saline 7 days after PCI.
autologous bone marrow mononuclear cells infusionProcedure or surgery
Also called autologous BMMC infusion, autologous bone marrow mononuclear cells transplantation, autologous BMMC intracoronary injection
Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Patients receive intracoronary injections of saline 7 days after PCI. Receives: Procedure: saline infusion |
| 2 | Experimental | Patients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI. Receives: Procedure: autologous bone marrow mononuclear cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left Ventricular Ejection Fraction(LVEF)
Measured: 1, 3, 6 months, 1, 4 years
Secondary outcomes (6)
in-stent restenosis
Measured: 1, 3, 6 months, 1, 4 years
cardiac shock
Measured: 1, 3, 6 months, 1, 4 years
myocardial viability of the infarcted area
Measured: 1, 3, 6 months, 1, 4 years
end-diastolic Volume/end-systolic Volume(EDV/ESV)
Measured: 1, 3, 6 months, 1, 4 years
wall motion score index(WMSI)
Measured: 1, 3, 6 months, 1, 4 years
cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization)
Measured: 1, 3, 6 months, 1, 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startMar 2003
- Primary completionMar 2008 (estimated)
- Study completionMar 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Xijing 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Haichang Wang, MD,PHD, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626145
- Sponsor's protocol ID
- 00200301
- Status last verified
- Feb 2008
- First submitted
- 20 Feb 2008
- Last updated
- 29 Feb 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Functional Evaluation After Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells in Patients With ST-Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00626145
- Acronym / sponsor ID
- 00200301
- Conditions
- Myocardial Infarction
- Keywords
- BMMNC, STEMI, stem cell, intracoronary delivery
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Mar 2003
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Mar 2008 (estimated)
- First posted
- 29 Feb 2008 (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 reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results. Our aim was to investigate 4 years' efficacy and LV functional improvement of autologous bone marrow mononuclear cells (BMMC) transplantation in patients with ST-elevation myocardial infarction.
Detailed description
The benefit of current reperfusion therapies for ST-elevation myocardial infarction (STEMI) is limited by post-infarction left ventricular (LV) dysfunction. Many clinic trails showed the short term outcome of bone marrow stem cell transplantation for MI patients, but rare report of long term follow-up results.
Aim is to evaluate the long term efficiency of unselected bone marrow mononuclear cells in treatment of patients with ST-elevation myocardial infarction (STEMI), especially with regard to the left ventricular function. The cells are delivered by intracoronary infusion 7 days after the PCI. Outcomes including LVEF, myocardial viability and coronary artery status are assessed by echocardiography, SPECT and coronary angiography.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Procedure: saline infusionPatients receive intracoronary injections of saline 7 days after PCI. |
| 2 | Experimental | Procedure: autologous bone marrow mononuclear cells infusionPatients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ST segment elevation myocardial infarction, according to the WHO definition.
- <24 hour from the origin of symptoms.
- Single left anterior descending coronary artery disease.
- Successful revascularization of culprit lesion with PCI.
- Age between 45 and 65 years old.
Key exclusion criteria (10 listed)
- Previous MI.
- Cardiomyopathy.
- Atrial fibrillation or fluctuation.
- Previous heart surgery.
- Severe valvular heart 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 |
|---|---|---|
| saline infusionAlso: saline placebo, placebo controlPatients receive intracoronary injections of saline 7 days after PCI. | Procedure or surgery | 1 |
| autologous bone marrow mononuclear cells infusionAlso: autologous BMMC infusion, autologous bone marrow mononuclear cells transplantation, autologous BMMC intracoronary injectionPatients receive intracoronary injections of autologous bone marrow mononuclear cells 7 days after PCI. | Procedure or surgery | 2 |
Primary outcome
Left Ventricular Ejection Fraction(LVEF)
Time frame: 1, 3, 6 months, 1, 4 years
6 secondary outcomes
in-stent restenosis
Time frame: 1, 3, 6 months, 1, 4 years
cardiac shock
Time frame: 1, 3, 6 months, 1, 4 years
myocardial viability of the infarcted area
Time frame: 1, 3, 6 months, 1, 4 years
end-diastolic Volume/end-systolic Volume(EDV/ESV)
Time frame: 1, 3, 6 months, 1, 4 years
wall motion score index(WMSI)
Time frame: 1, 3, 6 months, 1, 4 years
cumulative MACE(including cardiac death, non-fetal myocardial infarction and target lesion revascularization)
Time frame: 1, 3, 6 months, 1, 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2008.
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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.
Haichang Wang, MD,PHD principal investigator
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing saline infusion and autologous bone marrow mononuclear cells infusion in people with Myocardial Infarction, run by Xijing 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 6 inclusion and 10 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 29 Feb 2008. 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 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.
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?
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?
Left Ventricular Ejection Fraction(LVEF) (time frame: 1, 3, 6 months, 1, 4 years). 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 29 Feb 2008.