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A Phase II Dose-escalation Study to Assess the Feasibility and Safety of Transendocardial Delivery of Three Different Doses of Allogeneic Mesenchymal Precursor Cells (MPCs)in Subjects With Heart Failure

NCT00721045 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-03-11

No results posted yet for this study

Summary

This is a dose-ranging clinical study to evaluate the feasibility, safety, and tolerability of 3 different doses of immunoselected, culture expanded, nucleated, allogeneic MPCs in subjects who have cardiomyopathy of both ischemic and idiopathic etiology.

Conditions

Interventions

BIOLOGICAL

Mesenchymal Precursor Cells (MPCs)

25 M allogeneic MPCs by transendocardial injection and mapping.

BIOLOGICAL

Mesenchymal Precursor Cells (MPCs)

75 M allogeneic MPCs by transendocardial injection and mapping.

BIOLOGICAL

Mesenchymal Precursor Cells (MPCs)

150 M allogeneic MPCs by transendocardial injection

PROCEDURE

standard-of-care treatment with mock mapping and injection procedures.

Mock

PROCEDURE

standard-of-care treatment with mock mapping and injection procedures.

Mock

PROCEDURE

standard-of-care treatment with mock mapping and injection procedures.

Mock

Sponsors & Collaborators

  • Mesoblast, Ltd.

    lead INDUSTRY

Principal Investigators

  • Emerson Perin, MD · Texas Heart Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2011-06-30
Completion
2013-07-31

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 NCT00721045 on ClinicalTrials.gov