Myocardial InfarctionPhase 1/2NCT00555828
Safety Study of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction
A Phase 1/2 study testing Allogeneic Mesenchymal Precursor Cells (MPCs) and Standard-of-care treatment with NOGA® mapping and staged injections. in people with Myocardial Infarction, run by Angioblast Systems at 2 sites in United States.
Trial summary
Primary Objective The primary objective of this study is to evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic mesenchymal precursor cells (MPCs) in… 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?
- Allogeneic Mesenchymal Precursor Cells (MPCs) and Standard-of-care treatment with NOGA® mapping and staged injections.
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2008to Dec 2013
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older.
- An ST-elevation MI (STEMI) within 2 to 10 days of study enrollment. The STEMI must be documented by ECG with ST-segment elevation >1 mm in at least 2 contiguous precordial leads or in at least 2 adjacent limb leads. If there is a history of a previous AMI prior to the qualifying MI, then there must be a documented EF ≥ 50% by 2D echocardiogram within 12 months of enrollment.
- Successful percutaneous revascularization with Thrombolysis in Myocardial Infarction (TIMI)-3 flow of the infarct-related artery.
- A baseline 2D echocardiogram with EF ≥ 30 and ≤ 50% following PCI.
- Creatinine level ≤ 1.5mg/dL within 24 hours of study procedure.
- Hematocrit ≥ 30% within 24 hours of study procedure.
Show all 15Show fewer
- White Blood Cell count < 20k/mm3 within 24 hours of study procedure.
- Platelet count ≥ 100k/mm3 within 24 hours of study procedure.
- INR ≤ 1.7 within 24 hours of study procedure.
- Total bilirubin <3 mg/dL, albumin >2.8 g/dL, aspartate aminotransferase(AST) ≤ 2.5x the upper limit of normal, gamma glutamyltranspeptidase (GGT) ≤ 1.5 x the upper limit of normal.
- If the subject or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after surgery.
- Female subjects of childbearing potential must have a negative serum pregnancy test at screening (within 2 weeks of enrollment) and a negative serum or urine pregnancy test on the day of cell implantation.
- Willing and able to understand, sign, and date the Informed Consent Form (ICF).
- Must be willing to return for required follow-up visits.
- Must be able to follow postoperative management program.
Who cannot join
- Subject is hemodynamically unstable at Day 5 post-AMI as demonstrated by any of the following:
- Killip Class 4 indicative of cardiogenic shock.
- Requirement of intra-aortic balloon pump or IV inotropic support for the maintenance of mean arterial blood pressure ≥ 60 mmHg.
- Sustained ventricular tachycardia as demonstrated by QRS complexes wider than 120 msec, lasting >30 secs, and >100 bpm occurring >48 hours following PCI without any identifiable, reversible cause (ie, electrolyte imbalance).
- Further revascularization planned for the next 30 days.
- Chronic atrial fibrillation.
Show all 27Show fewer
- A wall thickness in the target region <8 mm as determined by 2D echocardiography(the target region is defined at the time of NOGA® mapping).
- An LV thrombus.
- Severe peripheral vascular disease precluding femoral artery access as determined at time of original catheterization.
- Aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to the LV.
- Echocardiographic evidence of hypertrophic cardiomyopathy indicating heart muscle thickness >15 mm.
- Human immunodeficiency virus (HIV)
- Serum glucose level ≥ 400 mg/dl within 24 hours of study procedure
- Serum glucose level 300-400 mg/dl and presence of urine ketones within 24 hours of study procedure.
- Claustrophobic, or with medical conditions or contradictions that impede performing baseline MRI study.
- An active uncontrolled infection.
- A prosthetic aortic valve.
- Presence of ≥ 20% anti-HLA antibody titers and/or having antibody specificities to donor HLA antigens.
- A current or prior history within the last 3 years of neoplasm (excluding basal cell) and/or any active neoplasm within the last 24 months.
- A known hypersensitivity to dimethyl sulfoxide (DMSO), murine and/or bovine products.
- Pregnancy or breastfeeding.
- Imprisoned at the time of enrollment.
- A treatment and/or an uncompleted follow-up treatment of any investigational therapy within 6 months before implantation surgery and intent to participate in any other investigational drug or cell therapy study during the 3-year follow-up period of this study.
- Active participation in other research therapy for cardiovascular repair/regeneration.
- A prior recipient of stem precursor cell therapy for cardiac repair.
- Any medical condition that would affect the investigator's ability to evaluate the subject's condition or could compromise the subject's safety.
- Any condition that, in the judgment of the investigator, would prohibit the subject from participating in the study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Texas Heart Institute/St. Luke's Hospital
Houston, Texas, 77030
Emerson C. Perin, MD, PhD
- Recruiting
University of Minnesota/Minneapolis Heart Institute
Minneapolis, Minnesota, 55407-1139
Timothy D. Henry, MD
About this study
Official title: A Phase 1b/2a Dose Escalation Study to Assess the Safety and Feasibility of Transendocardial Delivery of 3 Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction
Primary Objective The primary objective of this study is to evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.
SecondaryObjective
Read more
The secondary objectives are to explore functional efficacy for subsequent study design, as well as late-term dose related tolerance, by:
- Evaluating the effect of allogeneic MPCs on exploratory efficacy endpoints related to cardiac function on Days 90, 180, and 1 year
- Evaluating the change from baseline in the Medical Outcome Study Short Form (SF-36), Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and the New York Heart Association Classification at 30 days, 3 and 6 months, and 1, 2, and 3 years
- Evaluating follow-up safety through Day 360
- Providing preliminary data to support dose selection for future studies
- Conditions
- Myocardial Infarction
- Being tested
- Allogeneic Mesenchymal Precursor Cells (MPCs), Standard-of-care treatment with NOGA® mapping and staged injections.
- Keywords
- Myocardial Infarction, Myocardial infarct, Infarction
- Medical subject headings
- Myocardial Infarction, Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Mesenchymal Precursor Cells (MPCs)Genetic
25 M allogeneic MPCs by transendocardial injection
Standard-of-care treatment with NOGA® mapping and staged injections.Procedure or surgery
Standard-of-care treatment with NOGA® mapping and staged injections.
Allogeneic Mesenchymal Precursor Cells (MPCs)Genetic
75 M allogeneic MPCs by transendocardial injection
Standard-of-care treatment with NOGA® mapping and staged injections.Procedure or surgery
Standard-of-care treatment with NOGA® mapping and staged injections.
Allogeneic Mesenchymal Precursor Cells (MPCs)Genetic
150 M allogeneic MPCs by transendocardial injection
Standard-of-care treatment with NOGA® mapping and staged injections.Procedure or surgery
Standard-of-care treatment with NOGA® mapping and staged injections.
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | 5 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection Receives: Genetic: Allogeneic Mesenchymal Precursor Cells (MPCs) |
| A2 | Other | 5 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections. Receives: Procedure: Standard-of-care treatment with NOGA® mapping and staged injections. |
| B1 | Experimental | 5 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection Receives: Genetic: Allogeneic Mesenchymal Precursor Cells (MPCs) |
| B2 | Other | 3 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections. Receives: Procedure: Standard-of-care treatment with NOGA® mapping and staged injections. |
| C1 | Experimental | 5 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection Receives: Genetic: Allogeneic Mesenchymal Precursor Cells (MPCs) |
| C2 | Other | 2 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections. Receives: Procedure: Standard-of-care treatment with NOGA® mapping and staged injections. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.
Measured: 30 days
Secondary outcomes (1)
Explore efficacy for subsequent study design and dose related tolerance: •Effect related to cardiac function.•Change from baseline in SF-36, KCCQ, SAQ, and the NYHA Classification.•Follow-up safety through Day 360 • Dose selection for future stu
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startMar 2008
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (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.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angioblast Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Emerson C. Perin, MD, PhD, Principal investigator, Texas Heart Institute/St. Luke's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555828
- Sponsor's protocol ID
- EMT-AB001
- Status last verified
- Jun 2009
- First submitted
- 7 Nov 2007
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2a Dose Escalation Study to Assess the Safety and Feasibility of Transendocardial Delivery of 3 Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00555828
- Acronym / sponsor ID
- EMT-AB001
- Conditions
- Myocardial Infarction
- Keywords
- Myocardial Infarction, Myocardial infarct, Infarction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Angioblast SystemsIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 9 Nov 2007 (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.
Primary Objective The primary objective of this study is to evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of 25 M, 75 M, and 150 M allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.
SecondaryObjective
The secondary objectives are to explore functional efficacy for subsequent study design, as well as late-term dose related tolerance, by:
- Evaluating the effect of allogeneic MPCs on exploratory efficacy endpoints related to cardiac function on Days 90, 180, and 1 year
- Evaluating the change from baseline in the Medical Outcome Study Short Form (SF-36), Kansas City Cardiomyopathy Questionnaire, Seattle Angina Questionnaire, and the New York Heart Association Classification at 30 days, 3 and 6 months, and 1, 2, and 3 years
- Evaluating follow-up safety through Day 360
- Providing preliminary data to support dose selection for future studies
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Genetic: Allogeneic Mesenchymal Precursor Cells (MPCs)5 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection |
| A2 | Other | Procedure: Standard-of-care treatment with NOGA® mapping and staged injections.5 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections. |
| B1 | Experimental | Genetic: Allogeneic Mesenchymal Precursor Cells (MPCs)5 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection |
| B2 | Other | Procedure: Standard-of-care treatment with NOGA® mapping and staged injections.3 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections. |
| C1 | Experimental | Genetic: Allogeneic Mesenchymal Precursor Cells (MPCs)5 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection |
| C2 | Other | Procedure: Standard-of-care treatment with NOGA® mapping and staged injections.2 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age 18 years or older.
- An ST-elevation MI (STEMI) within 2 to 10 days of study enrollment. The STEMI must be documented by ECG with ST-segment elevation >1 mm in at least 2 contiguous precordial leads or in at least 2 adjacent limb leads. If there is a history of a previous AMI prior to the qualifying MI, then there must be a documented EF ≥ 50% by 2D echocardiogram within 12 months of enrollment.
- Successful percutaneous revascularization with Thrombolysis in Myocardial Infarction (TIMI)-3 flow of the infarct-related artery.
- A baseline 2D echocardiogram with EF ≥ 30 and ≤ 50% following PCI.
- Creatinine level ≤ 1.5mg/dL within 24 hours of study procedure.
Key exclusion criteria (27 listed)
- Subject is hemodynamically unstable at Day 5 post-AMI as demonstrated by any of the following:
- Sustained ventricular tachycardia as demonstrated by QRS complexes wider than 120 msec, lasting >30 secs, and >100 bpm occurring >48 hours following PCI without any identifiable, reversible cause (ie, electrolyte imbalance).
- Further revascularization planned for the next 30 days.
- Chronic atrial fibrillation.
- A wall thickness in the target region <8 mm as determined by 2D echocardiography(the target region is defined at the time of NOGA® mapping).
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 |
|---|---|---|
| Allogeneic Mesenchymal Precursor Cells (MPCs)25 M allogeneic MPCs by transendocardial injection | Genetic | A1 |
| Standard-of-care treatment with NOGA® mapping and staged injections.Standard-of-care treatment with NOGA® mapping and staged injections. | Procedure or surgery | A2 |
| Allogeneic Mesenchymal Precursor Cells (MPCs)75 M allogeneic MPCs by transendocardial injection | Genetic | B1 |
| Standard-of-care treatment with NOGA® mapping and staged injections.Standard-of-care treatment with NOGA® mapping and staged injections. | Procedure or surgery | B2 |
| Allogeneic Mesenchymal Precursor Cells (MPCs)150 M allogeneic MPCs by transendocardial injection | Genetic | C1 |
| Standard-of-care treatment with NOGA® mapping and staged injections.Standard-of-care treatment with NOGA® mapping and staged injections. | Procedure or surgery | C2 |
Primary outcome
Evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI.
Time frame: 30 days
1 secondary outcome
Explore efficacy for subsequent study design and dose related tolerance: •Effect related to cardiac function.•Change from baseline in SF-36, KCCQ, SAQ, and the NYHA Classification.•Follow-up safety through Day 360 • Dose selection for future stu
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
Emerson C. Perin, MD, PhD principal investigator
Texas Heart Institute/St. Luke's Hospital
2 sites 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 Allogeneic Mesenchymal Precursor Cells (MPCs) and Standard-of-care treatment with NOGA® mapping and staged injections. in people with Myocardial Infarction, run by Angioblast Systems at 2 sites 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 15 inclusion and 27 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 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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?
Contact Donna Skerrett, MD (1-888-369-2123, donna.skerrett@angioblast.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and feasibility of transendocardial injection using the Cordis Biosense NogaStarTM Mapping Catheter with the Biosense MyostarTM Left Ventricular Injection Catheter of allogeneic mesenchymal precursor cells (MPCs) in subjects with AMI. (time frame: 30 days). 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 17 Feb 2010.