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

Angioblast Systems2 sites in 1 country25 target enrollmentMarch 2008

ConditionsMyocardial Infarction

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Myocardial Infarction
Sponsor: Angioblast Systems
Enrollment: 25
Locations: 2
Primary Endpoint: 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.
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

March 2008

End Date

December 2013

Last Updated

16 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Angioblast Systems

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)