Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Heart Function in People Receiving an LVAD

NCT ID: NCT00927784

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-02-28

Brief Summary

Left ventricular assist devices (LVADs) are one treatment option for people with congestive heart failure. This study will evaluate the safety of injecting mesenchymal precursor cells (MPCs) into the heart during LVAD implantation surgery and examine if injecting MPCs into the heart is effective at improving heart function.

Detailed Description

Congestive heart failure is a major health problem and recent estimates indicate that end-stage heart failure with a 2-year mortality rate of 70-80% affects over 60,000 people in the United States each year. For these patients, treatment options are extremely limited. Less than 3,000 heart transplants are available each year because of the severely limited supply of donor hearts. Implantable LVADs, routinely used to support heart transplantation patients who decompensate awaiting a donor heart, were approved by the Food and Drug Administration (FDA) in 2002 for long-term support when heart transplantation is not an option. Few patients, however, achieve sufficient recovery to warrant LVAD explantation and those who do must still contend with ventricular dysfunction. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells. The purpose of this study is to determine the safety of injecting MPCs into the heart during LVAD implantation surgery. In addition, this study will examine whether injecting MPCs into the heart is effective at improving heart function.

This study will enroll people who are on the waiting list to receive a donor heart and who are undergoing LVAD implantation surgery. Before the surgery, participants will be randomly assigned to one of two groups. One group of participants will have MPCs injected into their heart during LVAD surgery and the other group of participants will have a control solution (placebo) injected into their heart during the surgery. A portion of heart muscle removed during the surgery will be analyzed. Participants will be monitored by study researchers and blood samples will be collected 12 hours after the LVAD surgery and at 1, 7, 21, 60, and 90 days after the surgery. After that, a medical history review, physical examination, and blood collection will occur every 60 days until a heart transplant occurs or until 12 months after the LVAD implantation, whichever comes first. Heart function testing, which will include an echocardiogram, neuronal function testing, and a 6-minute walk test, will occur 60 and 90 days after the LVAD implantation, and every 2 months thereafter until a heart transplant occurs or until 12 months after the LVAD implantation, whichever comes first.

Conditions

Heart Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cryoprotective media alone

Participants will receive intramyocardial injections of cryoprotective media alone (placebo).

Group Type: SHAM_COMPARATOR

Cryoprotective media alone

Intervention Type: DRUG

Participants will receive intramyocardial injections of cryoprotective media (placebo).

Mesenchymal Precursor cells (RevascorTM)

Participants will receive intramyocardial injections of low dose (25 million) or higher dose (75 million) MPCs in sequential cohorts.

Group Type: EXPERIMENTAL

Mesenchymal Precursor cells (RevascorTM)

Intervention Type: BIOLOGICAL

Participants will receive intramyocardial injections of low dose (25 million) or higher dose (75 million) MPCs (in sequential cohorts).

Interventions

Mesenchymal Precursor cells (RevascorTM)

Participants will receive intramyocardial injections of low dose (25 million) or higher dose (75 million) MPCs (in sequential cohorts).

Intervention Type: BIOLOGICAL

Cryoprotective media alone

Participants will receive intramyocardial injections of cryoprotective media (placebo).

Intervention Type: DRUG

Other Intervention Names

Mesenchymal Precursor cells; RevascorTM; placebo

Eligibility Criteria

Inclusion Criteria

• Signed informed consent, release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documents
• Age 18 years or older
• If the participant or partner is of childbearing potential, he or she must be willing to use adequate contraception (hormonal or barrier method or abstinence) from the time of screening and for a period of at least 16 weeks after LVAD implantation
• Female participants of childbearing potential must have a negative serum pregnancy test at screening
• Admitted to the clinical center at the time of study entry
• Listed with the United Network for Organ Sharing (UNOS) for heart transplantation
• Clinical indication and accepted candidate for implantation of an FDA- approved LVAD as a bridge to transplantation

Exclusion Criteria

• Cardiothoracic surgery within 30 days of study entry
• Heart attack within 30 days of study entry
• Prior heart transplantation, left ventricular (LV) reduction surgery, or cardiomyoplasty
• Acute reversible cause of heart failure (e.g., myocarditis, profound hypothyroidism)
• Anticipated requirement for biventricular mechanical support
• Stroke within 30 days of study entry
• Received investigational intervention within 30 days of study entry
• Platelet count less than 100,000/uL within 24 hours of study entry
• Active systemic infection within 48 hours of study entry
• Presence of greater than 10% anti-human leukocyte antigen (HLA) antibody titers with known specificity to the MPC donor HLA antigens
• Known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products
• History of cancer prior to screening (excluding basal cell carcinoma)
• Acute or chronic infectious disease, including but not limited to human immunodeficiency virus (HIV)
• Treatment and/or an incompleted follow-up treatment of any investigational therapy within 6 months of study entry
• Active participation in other research therapy for cardiovascular repair/regeneration
• Prior recipient of stem precursor cell therapy for cardiac repair
• Pregnant or breastfeeding at the time of study entry

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Angioblast Systems

INDUSTRY

Sponsor Role: collaborator

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Annetine Gelijns

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Ascheim, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Yoshifumi Naka, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Sharp Memorial Hospital

San Diego, California, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Jewish Hospital

Louisville, Kentucky, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

Mount Sinai Medical Center

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Temple University Hospital

Philadelphia, Pennsylvania, United States

Intermountain Medical Center

Salt Lake City, Utah, United States

Sacred Heart Medical Center

Spokane, Washington, United States

University of Wisconsin

Madison, Wisconsin, United States

St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Countries

United States

Other Identifiers

P50HL077096

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GCO 08-1093

Identifier Type: -

Identifier Source: org_study_id