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

NCT00927784 | Terminated Phase 2 Results DMC

• 2 other identifiers: GCO 08-1093P50HL077096
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 17

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.

Conditions

Heart Failure

Keywords

Mesenchymal Precursor Cells; Left Ventricular Assist Device; LVAD; Congestive Heart Failure; Stem Cells

Outcome Measures

Primary Outcomes (5)

• Incidence of Infectious Myocarditis

  Measured within 90 days of study entry

• Incidence of Myocardial Rupture

  Measured within 90 days of study entry

• Incidence of Neoplasm

  Measured within 90 days of study entry

• Incidence of Hypersensitivity Reaction

  Measured within 90 days of study entry

• Incidence of Immune Sensitization

  Measured within 90 days of study entry

Secondary Outcomes (8)

• Assessment of LVAD Wean

  up to 12 months

• Incidence of Study Intervention-related Adverse Events

  up to 12 months

• Incidence of All Serious Adverse Events

  up to 12 months

• Number of Patients Who Experienced Donor-specific HLA Sensitization

  up to 12 months

• Incidence of Myocardial Neovascularization at Time of Explant

  up to 12 months

Study Arms (2)

Cryoprotective media alone

SHAM COMPARATOR

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

Drug: Cryoprotective media alone

Mesenchymal Precursor cells (RevascorTM)

EXPERIMENTAL

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

Biological: Mesenchymal Precursor cells (RevascorTM)

Interventions

Mesenchymal Precursor cells (RevascorTM) BIOLOGICAL

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

Also known as: Mesenchymal Precursor cells, RevascorTM

Mesenchymal Precursor cells (RevascorTM)

Cryoprotective media alone DRUG

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

Also known as: placebo

Cryoprotective media alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Angioblast Systems: collaborator

Study Sites (17)

Sharp Memorial Hospital

San Diego, California, 92123, United States

Location

Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Mount Sinai Medical Center

New York, New York, 10029, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140, United States

Location

Intermountain Medical Center

Salt Lake City, Utah, 84107, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

St. Luke's Medical Center

Milwaukee, Wisconsin, 53215, United States

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

After the 10th patient was enrolled,enrollment was permanently suspended due to a change in NIH funding. Enrollment activity ceased and study was terminated.

Results Point of Contact

• Title: Deborah Ascheim, MD, Principal Investigator, Data Coordinating Center
• Organization: Mount Sinai School of Medicine

deborah.ascheim@mssm.edu

212-659-9567

Study Officials

• Deborah Ascheim, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Yoshifumi Naka, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 23, 2009
• First Posted: June 25, 2009
• Study Start: August 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: February 1, 2011
• Last Updated: March 5, 2019
• Results First Posted: March 5, 2019

Record last verified: 2019-02

Locations

US (17)