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Safety Study of AMI MultiStem® to Treat Heart Attacks

NCT00677222 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-05-11

No results posted yet for this study

Summary

The purpose of this study is to determine if escalating doses of AMI MultiStem® delivered by catheter can safely be given to patients that have had a recent heart attack treated with stent implantation.

Conditions

  • Acute Myocardial Infarction

Interventions

BIOLOGICAL

AMI MultiStem®

AMI MultiStem® administered via catheter into peri-vascular space of the target vessel, 2-5 days post PCI. There will be 3 dose escalation cohorts, 6 patients per cohort.

Sponsors & Collaborators

  • PPD Development, LP

    collaborator INDUSTRY

  • Angiotech Pharmaceuticals

    collaborator INDUSTRY

  • Healios K.K.

    lead INDUSTRY

Principal Investigators

  • Marc Penn, MD · The Cleveland Clinic

  • Warren Sherman, MD · Columbia University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2010-03-31
Completion
2012-02-29

Countries

  • United States

Study Locations

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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 NCT00677222 on ClinicalTrials.gov