Safety Study of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction
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
1 other identifier
interventional
25
1 country
2
Brief 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 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Mar 2008
Longer than P75 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2007
CompletedFirst Posted
Study publicly available on registry
November 9, 2007
CompletedStudy Start
First participant enrolled
March 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFebruary 17, 2010
June 1, 2009
5.8 years
November 7, 2007
February 16, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
3 years
Study Arms (6)
A1
EXPERIMENTAL5 subjects randomized to receive 25 M allogeneic MPCs by transendocardial injection
A2
OTHER5 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections.
B1
EXPERIMENTAL5 subjects randomized to receive 75 M allogeneic MPCs by transendocardial injection
B2
OTHER3 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections.
C1
EXPERIMENTAL5 subjects randomized to receive 150 M allogeneic MPCs by transendocardial injection
C2
OTHER2 subjects randomized to receive standard-of-care treatment with NOGA® mapping and staged injections.
Interventions
25 M allogeneic MPCs by transendocardial injection
Standard-of-care treatment with NOGA® mapping and staged injections.
Eligibility Criteria
You may qualify if:
- 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.
- 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.
You may not qualify if:
- 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.
- 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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University of Minnesota/Minneapolis Heart Institute
Minneapolis, Minnesota, 55407-1139, United States
Texas Heart Institute/St. Luke's Hospital
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Emerson C. Perin, MD, PhD
Texas Heart Institute/St. Luke's Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 7, 2007
First Posted
November 9, 2007
Study Start
March 1, 2008
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
February 17, 2010
Record last verified: 2009-06