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Safety Study of Allogeneic Mesenchymal Precursor Cells (MPCs) in Subjects With Recent Acute Myocardial Infarction

NCT00555828 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2010-02-17

No results posted yet for this study

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

Conditions

Interventions

GENETIC

Allogeneic Mesenchymal Precursor Cells (MPCs)

25 M allogeneic MPCs by transendocardial injection

PROCEDURE

Standard-of-care treatment with NOGA® mapping and staged injections.

Standard-of-care treatment with NOGA® mapping and staged injections.

GENETIC

Allogeneic Mesenchymal Precursor Cells (MPCs)

75 M allogeneic MPCs by transendocardial injection

PROCEDURE

Standard-of-care treatment with NOGA® mapping and staged injections.

Standard-of-care treatment with NOGA® mapping and staged injections.

GENETIC

Allogeneic Mesenchymal Precursor Cells (MPCs)

150 M allogeneic MPCs by transendocardial injection

PROCEDURE

Standard-of-care treatment with NOGA® mapping and staged injections.

Standard-of-care treatment with NOGA® mapping and staged injections.

Sponsors & Collaborators

  • Angioblast Systems

    lead INDUSTRY

Principal Investigators

  • Emerson C. Perin, MD, PhD · Texas Heart Institute/St. Luke's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-03-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555828 on ClinicalTrials.gov