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Heart FailurePhase 2NCT00927784

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

A Phase 2 study testing Mesenchymal Precursor cells (RevascorTM) and Cryoprotective media alone in people with Heart Failure, run by Icahn School of Medicine at Mount Sinai at 17 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Heart Failure
What is being tested?
Mesenchymal Precursor cells (RevascorTM) and Cryoprotective media alone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
10 participants
Where
17 sitesUnited States
Study dates
Aug 2009to Feb 2011
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

United States17 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Ohio State University Medical Center

    Columbus, Ohio, 43210

  • Jewish Hospital

    Louisville, Kentucky, 40202

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • St. Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • Intermountain Medical Center

    Salt Lake City, Utah, 84107

  • Sharp Memorial Hospital

    San Diego, California, 92123

  • Sacred Heart Medical Center

    Spokane, Washington, 99204

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Washington Hospital Center

    Washington D.C., District of Columbia, 20010

Other trials in United States

About this study

Official title: The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Bridge to Transplant Patients

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.

Read the 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
Being tested
Mesenchymal Precursor cells (RevascorTM), Cryoprotective media alone
Keywords
Mesenchymal Precursor Cells, Left Ventricular Assist Device, LVAD, Congestive Heart Failure, Stem Cells
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal Precursor cells (RevascorTM)Biological

    Also called Mesenchymal Precursor cells, RevascorTM

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

  • Cryoprotective media aloneDrug

    Also called placebo

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

Study groups in NCT00927784
Study groupRoleWhat they receive
Cryoprotective media aloneSham comparatorParticipants will receive intramyocardial injections of cryoprotective media alone (placebo).
Receives: Drug: Cryoprotective media alone
Mesenchymal Precursor cells (RevascorTM)ExperimentalParticipants will receive intramyocardial injections of low dose (25 million) or higher dose (75 million) MPCs in sequential cohorts.
Receives: Biological: Mesenchymal Precursor cells (RevascorTM)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Infectious Myocarditis

    Measured: Measured within 90 days of study entry

  2. Incidence of Myocardial Rupture

    Measured: Measured within 90 days of study entry

  3. Incidence of Neoplasm

    Measured: Measured within 90 days of study entry

  4. Incidence of Hypersensitivity Reaction

    Measured: Measured within 90 days of study entry

  5. Incidence of Immune Sensitization

    Measured: Measured within 90 days of study entry

Secondary outcomes (8)

  1. Assessment of LVAD Wean

    The secondary endpoints assessed during the LVAD wean include echocardiographic assessments, 6 minute walk, ability to tolerate wean from LVAD support, duration of ability to tolerate wean from LVAD support, and neuronal function.

    Measured at 60 days, 90 days, and every 60 days thereafter following LVAD implantation until heart transplantation or 12 months, whichever comes first

    Measured: up to 12 months

  2. Incidence of Study Intervention-related Adverse Events

    This includes Device Malfunction-Pump Thrombus-Suspected and Internal Pump Component, Inflow, or Outflow Tract Infection

    Measured: up to 12 months

  3. Incidence of All Serious Adverse Events

    Measured: up to 12 months

  4. Number of Patients Who Experienced Donor-specific HLA Sensitization

    Number of patients who experienced donor-specific HLA sensitization post-randomization in each treatment arm.

    Measured: up to 12 months

  5. Incidence of Myocardial Neovascularization at Time of Explant

    Measured: up to 12 months

  6. Incidence of Cardiomyocyte Regeneration at Explant

    Measured: up to 12 months

  7. Incidence of Cell Engraftment and Fate at Explant

    Measured: up to 12 months

  8. Incidence of Survival to Cardiac Transplantation

    Measured: up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2009 (estimated)
  2. Study startAug 2009
  3. Primary completionMay 2010
  4. Study completionFeb 2011

Why it stopped: The enrollment has been terminated by the NHLBI for administrative reasons.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00927784
Sponsor's protocol ID
GCO 08-1093
Other IDs
P50HL077096
Status last verified
Feb 2019
First submitted
23 Jun 2009
Last updated
5 Mar 2019
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesenchymal Precursor cells (RevascorTM) and Cryoprotective media alone in people with Heart Failure, run by Icahn School of Medicine at Mount Sinai at 17 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 5 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Infectious Myocarditis (time frame: Measured within 90 days of study entry). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00927784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2019.

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