Prospective Randomized Study of Mesenchymal Stem Cell Therapy in Patients Undergoing Cardiac Surgery (PROMETHEUS)

Summary

Heart attacks are a leading cause of death in both men and women in the United States. When a person has a heart attack, blood is unable to reach a certain area of the heart, and if the blood supply is not re-established quickly, that area of the heart can suffer permanent damage. While recovery from a heart attack can be managed through medications and lifestyle changes, these treatments can not reverse the original damage to the heart. Current research is focusing on the development of cell-based therapies using stem cells to repair organs that have been irreversibly damaged by disease. A specific form of stem cells, called adult mesenchymal stem cells (MSCs), has shown promise for heart repair. This study will evaluate the safety and effectiveness of injecting MSCs into the heart to repair and restore heart function in people who have had a heart attack and who are having heart surgery for coronary artery bypass grafting (CABG).

Conditions

• Stem Cell Transplantation
• Ventricular Dysfunction, Left

Interventions

BIOLOGICAL

Lower dose mesenchymal stem cell (MSC) injection

Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 10\^7 cells. The injections will be administered following completion of CABG surgery.

GENETIC

Placebo

Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA).

BIOLOGICAL

Higher dose MSC injection

Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 10\^8 cells. The injections will be administered following completion of CABG surgery.

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Johns Hopkins University Specialized Center for Cell Based Therapy

  collaborator OTHER

• The Emmes Company, LLC

  collaborator INDUSTRY

• Joshua M Hare

  lead OTHER

Principal Investigators

• Joshua M. Hare, MD · University of Miami

• Gary Gerstenblith, MD · Johns Hopkins University

• John V. Conte, MD · Johns Hopkins University

• Steven P. Schulman, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-11-30

Primary Completion

2011-06-30

Completion

2011-06-30

FDA Drug

Yes

Countries

• United States

Study Locations