Myocardial InfarctionPhase 1AMR-1NCT00313339
Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction
A Phase 1 study testing Intra-coronary infusion in people with Myocardial Infarction and Coronary Artery Disease, run by Emory University at 1 site in United States.
Trial summary
Following a Heart attack the acute loss of heart muscle cells results in a cascade of events causing an immediate decrease in cardiac function that has the potential to persist long term. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Myocardial Infarction, Coronary Artery Disease
- What is being tested?
- Intra-coronary infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Mar 2013
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 75 years.
- Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of chest pain within 3 days of admission. Criteria include (ST elevation > 1mm in limb leads or 2 mm in two or more precordial leads and increased levels of troponin, CPK MB or both)
- NYHA heart failure class of I, II or III
Who cannot join
- Patients who are not candidates for percutaneous intervention, conscious sedation, MRI, SPECT imaging or mini-bone marrow harvest
- History of sustained chest pain unrelieved by nitrates, occurring 4 or more days before revascularization.
- Patients who fail to re-perfuse the infarct related coronary artery or have successful stent placement
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AMORCYTE MYOCARDIAL REPAIR STUDY- A Phase I Trial of Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction. (AMRS)
Following a Heart attack the acute loss of heart muscle cells results in a cascade of events causing an immediate decrease in cardiac function that has the potential to persist long term. Despite revascularization of the infarct related artery circulation and appropriate medical management to minimize the stresses on the heart walls, a significant percentage of patients experience permanent cardiac dysfunction and consequently remain at an increased life-time risk of experiencing adverse cardiac events, including death.
There is a great potential for stem cell therapy, using a variety of cell precursors (particularly hematopoietic,)to contribute to new blood vessel formation (and possibly limited heart muscle formation) and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies.
Read more
Therefore, we propose to evaluate the safety and efficacy of a CD34+ selected stem cell product (AMR-001), administered through the infarct related coronary artery 6 to 9 days after successful infarct related artery stent placement.
The primary objective of the study is to determine the feasibility and safety of prospectively identifying patients at risk for clinically significant cardiac dysfunction following a myocardial infarction and the ability to isolate and infuse via the affected coronary circulation an autologous bone marrow derived CD34+ cell product at four dose levels.
The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent patient group meeting eligibility but not receiving CD34+ cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function without CD34+cell infusion.
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Being tested
- Intra-coronary infusion
- Keywords
- myocardial infarction, bone marrow, cd34+, stem cells
- Medical subject headings
- Myocardial Infarction, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-coronary infusionDrug
In our study there will be four dosing cohorts (5, 10, 20 and 30 x 106) of CD34+ cells.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | A concurrent group meeting eligibility criteria but not receiving CD34+cells will be evaluated similar to the study group to assess the extent, if any, of significant improvement in cardiac perfusion/function without the CD34+cell product infusion. |
| Treatment Group | Experimental | Intra-coronary infusion of an autologous bone marrow derived CD34+ stem cell product. Receives: Drug: Intra-coronary infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac function at 3 and 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion.
Measured: 3 & 6 Months
Secondary outcomes (2)
Perfusion of the infarct region at 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion
Measured: 6 Months
An assessment will be performed to determine if a correlation exist between clinical outcome and cell content (CD34+) and/or in vitro colony growth (CFU-GM, CFU-GEMM, BFU-E) CXCR-4 mobility and CXCR-4 and/or VEGF surface antigen expression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startMar 2006
- Primary completionMar 2009
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- Factorial
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Texas Heart Institute
- Responsible party
- Principal investigator, Arshed A. Quyyumi, Emory University
- Investigators
- ARSHED A QUYYUMI, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313339
- Sponsor's protocol ID
- 0076-2006
- Other IDs
- FDA IND 12584
- Acronym
- AMR-1
- Status last verified
- Nov 2013
- First submitted
- 10 Apr 2006
- Last updated
- 18 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Quyyumi AA, Waller EK, Murrow J, Esteves F, Galt J, Oshinski J, Lerakis S, Sher S, Vaughan D, Perin E, Willerson J, Kereiakes D, Gersh BJ, Gregory D, Werner A, Moss T, Chan WS, Preti R, Pecora AL. CD34(+) cell infusion after ST elevation myocardial infarction is associated with improved perfusion and is dose dependent. Am Heart J. 2011 Jan;161(1):98-105. doi: 10.1016/j.ahj.2010.09.025.
PubMed 21167340Murrow J, Esteves F, Galt J, Chen J, Garcia E, Lin J, Lerakis S, Sher S, Khan Pohlel F, Waller EK, Vaughan D, Perin E, Willerson J, Kereiakes D, Preti R, Pecora AL, Quyyumi AA. Characterization of mechanical dyssynchrony measured by gated single photon emission computed tomography phase analysis after acute ST-elevation myocardial infarction. J Nucl Cardiol. 2011 Oct;18(5):912-9. doi: 10.1007/s12350-011-9414-8. Epub 2011 Jun 30.
PubMed 21717276
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMORCYTE MYOCARDIAL REPAIR STUDY- A Phase I Trial of Intra-coronary Infusion of Bone Marrow Derived Autologous CD34+ Selected Cells in Patients With Acute Myocardial Infarction. (AMRS)
- ClinicalTrials.gov ID
- NCT00313339
- Acronym / sponsor ID
- AMR-1 / 0076-2006
- Conditions
- Myocardial Infarction, Coronary Artery Disease
- Keywords
- myocardial infarction, bone marrow, cd34+, stem cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Texas Heart Institute
- Study start
- Mar 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 12 Apr 2006 (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.
Following a Heart attack the acute loss of heart muscle cells results in a cascade of events causing an immediate decrease in cardiac function that has the potential to persist long term. Despite revascularization of the infarct related artery circulation and appropriate medical management to minimize the stresses on the heart walls, a significant percentage of patients experience permanent cardiac dysfunction and consequently remain at an increased life-time risk of experiencing adverse cardiac events, including death.
There is a great potential for stem cell therapy, using a variety of cell precursors (particularly hematopoietic,)to contribute to new blood vessel formation (and possibly limited heart muscle formation) and muscle preservation in the myocardial infarct zone. The administration of cells via an infusion through the infarct related artery appears to be feasible and result in a clinical effect in some studies.
Therefore, we propose to evaluate the safety and efficacy of a CD34+ selected stem cell product (AMR-001), administered through the infarct related coronary artery 6 to 9 days after successful infarct related artery stent placement.
The primary objective of the study is to determine the feasibility and safety of prospectively identifying patients at risk for clinically significant cardiac dysfunction following a myocardial infarction and the ability to isolate and infuse via the affected coronary circulation an autologous bone marrow derived CD34+ cell product at four dose levels.
The secondary objective of the study is to assess the effect on cardiac function and infarct region perfusion. A concurrent patient group meeting eligibility but not receiving CD34+ cells will be evaluated similar to the treated group to assess the rate of significant spontaneous improvement in cardiac function without CD34+cell infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –A concurrent group meeting eligibility criteria but not receiving CD34+cells will be evaluated similar to the study group to assess the extent, if any, of significant improvement in cardiac perfusion/function without the CD34+cell product infusion. |
| Treatment Group | Experimental | Drug: Intra-coronary infusionIntra-coronary infusion of an autologous bone marrow derived CD34+ stem cell product. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 - 75 years.
- Acute ST elevation myocardial infarction meeting ACC/AHA criteria, with symptoms of chest pain within 3 days of admission. Criteria include (ST elevation > 1mm in limb leads or 2 mm in two or more precordial leads and increased levels of troponin, CPK MB or both)
- NYHA heart failure class of I, II or III
Key exclusion criteria (3 listed)
- Patients who are not candidates for percutaneous intervention, conscious sedation, MRI, SPECT imaging or mini-bone marrow harvest
- History of sustained chest pain unrelieved by nitrates, occurring 4 or more days before revascularization.
- Patients who fail to re-perfuse the infarct related coronary artery or have successful stent placement
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 |
|---|---|---|
| Intra-coronary infusionIn our study there will be four dosing cohorts (5, 10, 20 and 30 x 106) of CD34+ cells. | Drug | Treatment Group |
Primary outcome
Cardiac function at 3 and 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion.
Time frame: 3 & 6 Months
2 secondary outcomes
Perfusion of the infarct region at 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion
Time frame: 6 Months
An assessment will be performed to determine if a correlation exist between clinical outcome and cell content (CD34+) and/or in vitro colony growth (CFU-GM, CFU-GEMM, BFU-E) CXCR-4 mobility and CXCR-4 and/or VEGF surface antigen expression.
Time frame: Baseline
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 18 Nov 2013.
- Background: PubMed 21167340Quyyumi AA, Waller EK, Murrow J, Esteves F, Galt J, Oshinski J, Lerakis S, Sher S, Vaughan D, Perin E, Willerson J, Kereiakes D, Gersh BJ, Gregory D, Werner A, Moss T, Chan WS, Preti R, Pecora AL. CD34(+) cell infusion after ST elevation myocardial infarction is associated with improved perfusion and is dose dependent. Am Heart J. 2011 Jan;161(1):98-105. doi: 10.1016/j.ahj.2010.09.025.
- Results publication: PubMed 21717276Murrow J, Esteves F, Galt J, Chen J, Garcia E, Lin J, Lerakis S, Sher S, Khan Pohlel F, Waller EK, Vaughan D, Perin E, Willerson J, Kereiakes D, Preti R, Pecora AL, Quyyumi AA. Characterization of mechanical dyssynchrony measured by gated single photon emission computed tomography phase analysis after acute ST-elevation myocardial infarction. J Nucl Cardiol. 2011 Oct;18(5):912-9. doi: 10.1007/s12350-011-9414-8. Epub 2011 Jun 30.
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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.
ARSHED A QUYYUMI, MD principal investigator
Emory University
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 Intra-coronary infusion in people with Myocardial Infarction and Coronary Artery Disease, run by Emory University at 1 site in United States.
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 3 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 18 Nov 2013. 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 United States. 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?
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?
Cardiac function at 3 and 6 months follow-up will be compared to baseline measures obtained the day(s) before CD34+ cell product infusion. (time frame: 3 & 6 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 NCT00313339, which also lists 2 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 18 Nov 2013.