Bone Marrow Cell Transplantation to Improve Heart Function in Individuals With End-Stage Heart Failure

NCT00383630 | Terminated Phase 2 Results DMC

• 3 other identifiers: AAAC2128P50HL077096P50HL077096-01
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 7

Brief Summary

Heart failure is a condition in which the heart is unable to pump enough blood to the body's other organs. A heart transplant may be necessary for some individuals with end-stage heart failure. Left ventricular assist devices (LVADs) can assist the heart in pumping blood, and are commonly used until a donor heart becomes available. Bone marrow cells injected into the heart may improve heart function and may lead to earlier LVAD removal. The purpose of this study is to evaluate the safety and effectiveness of injected bone marrow cells in improving heart function in individuals with LVADs who are awaiting heart transplants.

Conditions

Heart Failure, Congestive

Keywords

End Stage Heart Failure; LVAD; Bone Marrow Transplantation; Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

• Duration of Time (Minutes) a Patient is Able to Tolerate Wean

  This defines the functional status. Due to poor enrollment, data was not analyzed.

  Measured 90 days post-intervention

Secondary Outcomes (2)

• Prevalence of Normal Echocardiographic Assessments

  Measured at baseline, Days 45 and 90 post-intervention, every 60 days thereafter until transplant

• Number of Patients Who Completed a Six Minute Walk

  Measured at Days 45 and 90 post-intervention, every 60 days thereafter until transplant

Study Arms (3)

Group 1

EXPERIMENTAL

Intramyocardial injection of bone marrow mononuclear cells + LVAD

Biological: Intramyocardial injection of bone marrow mononuclear cells

Group 2

EXPERIMENTAL

Intramyocardial injection of CD34+ selected bone marrow mononuclear cells + LVAD

Biological: Intramyocardial injection of CD34+ selected bone marrow mononuclear cells

Group 3

OTHER

LVAD alone

Device: LVAD alone

Interventions

Intramyocardial injection of bone marrow mononuclear cells BIOLOGICAL

6mL of bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.

Also known as: BMCs + LVAD

Group 1

Intramyocardial injection of CD34+ selected bone marrow mononuclear cells BIOLOGICAL

6mL of CD34+ selected bone marrow mononuclear cells will be injected into the myocardium during LVAD implantation.

Also known as: CD34+ selected BMCs + LVAD

Group 2

LVAD alone DEVICE

LVAD implantation without any intramyocardial injection of bone marrow cells.

Group 3

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
• Male, postmenopausal female, or female who may become pregnant but is using adequate contraceptive precautions (defined as use of oral contraceptive, intrauterine devices, surgical contraception, or a combination of a condom and a spermicide), with negative pregnancy test
• Admitted to the clinical center at the time of study entry
• Listed with United Network for Organ Sharing (UNOS) for cardiac transplantation
• Clinical indication and accepted candidate for implantation of an FDA approved LVAD as a bridge to transplantation
• Hemoglobin between 9.0 gm/dl and 16.1 gm/dl within 24 hours prior to study entry
• Platelet count between 100,000/ul and 450,000/ul within 24 hours prior to study entry
• White blood cell count between 2,500/ul and upper limit of normal within 24 hours prior to study entry

You may not qualify if:

• Cardiothoracic surgery within 30 days prior to study entry
• Myocardial infarction within 6 months prior to study entry
• Prior cardiac 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 prior to study entry
• Received investigational intervention within 30 days of study entry
• Pregnant or breastfeeding at time of study entry
• HIV positive within 30 days prior to study entry
• Active systemic infection within 48 hours prior to study entry

Sponsors & Collaborators

• Columbia University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (7)

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Jewish Hospital

Louisville, Kentucky, 40202, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4227, United States

Location

University of Wisconsin

Madison, Wisconsin, 53792-3236, 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

Results Point of Contact

• Title: Yoshifumi Naka, MD, PhD
• Organization: Columbia University

yn33@columbia.edu

(212) 305-0828

Study Officials

• Yoshifumi Naka, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Department of Surgery CT

Study Record Dates

• First Submitted: September 29, 2006
• First Posted: October 3, 2006
• Study Start: September 1, 2007
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: April 17, 2019
• Results First Posted: April 17, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)