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Heart FailurePhase 2NCT02362646

Safety & Efficacy of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in LVAD Recipients

A Phase 2 study testing MPC Intramyocardial Injection in people with Heart Failure and Cardiomyopathy, run by Annetine Gelijns at 19 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MPC Intramyocardial Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
159 participants
Where
19 sitesin 2 countries
Study dates
Jul 2015to 23 Aug 2019
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, inclusive of release of medical information, and Health Insurance Portability and Accountability Act (HIPAA) documentation
  • Age 18 years or older
  • If the subject 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 procedure
  • Female subjects of childbearing potential must have a negative serum pregnancy test at screening
  • Admitted to the clinical center at the time of randomization
  • Clinical indication and accepted candidate for implantation of an FDA-approved (US sites only) or Health Canada-approved (Canadian sites only) implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.

Who cannot join

  • Planned percutaneous LVAD implantation
  • Anticipated requirement for biventricular mechanical support
  • Concomitant arrhythmia ablation at time of LVAD implantation
  • -- Planned aortic valve intervention for aortic insufficiency at the time of LVAD implantation
  • Cardiothoracic surgery within 30 days prior to randomization
  • Spontaneous myocardial infarction related to ischemia due to a primary coronary event such as unstable plaque rupture, erosion or dissection within 30 days prior to randomization
Show all 21Show fewer
  • Prior cardiac transplantation, LV reduction surgery, or cardiomyoplasty
  • Acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism)
  • Stroke within 30 days prior to randomization
  • Platelet count < 100,000/ul within 24 hours prior to randomization
  • Acute infectious process: acute bacterial, fungal, or viral disease OR acute exacerbation of chronic infectious disease such as hepatitis
  • Presence of >10% anti-HLA antibody titers with known specificity to MPC donor HLA antigens
  • A known hypersensitivity to dimethyl sulfoxide (DMSO), murine, and/or bovine products
  • History of a known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated
  • Presence of human immunodeficiency virus (HIV)
  • Received investigational intervention within 30 days prior to randomization
  • Treatment and/or an incomplete follow-up treatment of any investigational cell based therapy within 6 months prior to randomization
  • Active participation in other research therapy for cardiovascular repair/regeneration
  • Prior recipient of stem precursor cell therapy for cardiac repair
  • Pregnant or breastfeeding at time of randomization.
  • History of known or suspected hypercoagulable state in the opinion of the investigator

Trial locations and contacts

19 sites in 2 countries.

19 sites in 2 countries

United States16 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • University of Maryland

    Baltimore, Maryland, 21201

  • University of Virginia Health Systems

    Charlottesville, Virginia, 22908

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Duke University

    Durham, North Carolina, 27710

  • University of Southern California

    Los Angeles, California, 90033

  • University of Wisconsin School of Medicine and Public Health

    Madison, Wisconsin, 53726

  • Columbia University Medical Center

    New York, New York, 10032

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • Baylor Research Institute

    Plano, Texas, 75093

  • University of Utah

    Salt Lake City, Utah, 84132

  • Stanford University School of Medicine

    Stanford, California, 94305

  • Montefiore Einstein Heart Center

    The Bronx, New York, 10467

Other trials in United States

Canada3 sites

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • Institut Universitaire de Cardiologie de Quebec (Hopital Laval)

    Québec, Quebec, G1V 4G5

  • Toronto General Hospital

    Toronto, Ontario, M5G 2C4

Other trials in Canada

About this study

The main purpose of this research is to determine whether injecting mesenchymal precursor cells (MPC) into the heart during surgery to implant a left ventricular assist device (LVAD) is safe. MPCs are normally present in human bone marrow and have been shown to increase the development of blood vessels and new heart muscle cells in the heart. In addition, this research is being done to test whether injecting the MPCs into the heart is effective in improving heart function.

Read the detailed description

Intramyocardial injection of mesenchymal precursor cells (MPC) in patients with advanced heart failure who are treated with left ventricular assist device (LVAD) implantation may result in a renewable source of proliferating functional cardiomyocytes; induce development of capillaries and larger-size blood vessels to supply oxygen and nutrients to endogenous myocardium and newly-implanted cardiomyocytes; and release factors capable of paracrine signaling.

Being tested
MPC Intramyocardial Injection, Control Solution
Keywords
Heart Failure, Left Ventricular Assist Device, Heart Transplantation, Cardiomyopathy, Destination Therapy, Cell Therapy, Bridge to Transplant
Medical subject headings
Heart Failure, Cardiomyopathies, Ventricular Dysfunction

What participants receive

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

  • MPC Intramyocardial InjectionBiological

    Also called Mesenchymal Precursor Cell Injection, RevascorTM

    Intramyocardial injection of 150 million mesenchymal precursor cells at the time of LVAD implantation

  • Control SolutionDrug

    Also called 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO, Cryoprotective media

Study groups in NCT02362646
Study groupRoleWhat they receive
MPC Intramyocardial InjectionExperimentalIntramyocardial injections of 150 million MPCs
Receives: Biological: MPC Intramyocardial Injection
Control SolutionSham comparatorIntramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
Receives: Drug: Control Solution

What is being measured

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

  1. Number of Temporary Weans From LVAD Support Tolerated

    functional status, defined by the number of temporary weans from LVAD support tolerated over the 6 months post-randomization. A successful wean is the ability to tolerate temporary weaning from LVAD support for 30 minutes without sustained symptoms of worsening heart failure. Wean failures are defined as inability to tolerate the temporary wean for 30 minutes; death; or patient too unstable, in the judgment of the primary heart failure cardiologist, to tolerate the wean attempt.

    Measured: up to 6 months

  2. Number of Participants With Adverse Events

    Safety as assessed by number of study intervention-related adverse events

    Measured: up to 6 months

Secondary outcomes (14)

  1. Physiologic Assessments

    Echocardiographic assessments of the myocardial size and function by transthoracic echocardiography with LVAD at full support, and as tolerated following 6-Minute Walk Test (MWT) while weaned from LVAD support (for patients who tolerate wean from LVAD support for 30 minutes)

    Measured: up to 12 months

  2. Histopathological Assessments of Myocardial Tissue

    Measured: up to 12 months

  3. Overall Survival

    Measured: up to 12 months

  4. Change in Quality of Life (QoL)

    Quality of life will be assessed with the Kansas City Cardiomyopathy Questionnaire (KCCQ), a widely used tool in heart failure populations, and the Short Form 12 (SF12), a widely used overall health status measure.

    Measured: 6 months and 12 months

  5. Hopkins Verbal Learning Test

    Cognitive performance will be assessed Hopkins Verbal Learning Test. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

    Measured: 3 months and 12 months

  6. Trailmaking Tests A and B

    Cognitive performance will be assessed using Trailmaking Tests A and B. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

    Measured: 3 months and 12 months

  7. MCG Complex Figures

    Cognitive performance will be assessed using the MCG Complex Figures. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

    Measured: 3 months and 12 months

  8. Digit Span

    Cognitive performance will be assessed using the MCG Complex Figures. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

    Measured: 3 months and 12 months

  9. Digit Symbol Substitution Test

    Cognitive performance will be assessed using the Digit Symbol Substitution Test. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

    Measured: 3 months and 12 months

  10. Controlled Oral Word Association

    Cognitive performance will be assessed using the Controlled Oral Word Association. Neurocognitive testing will be administered by clinical site personnel who have been trained and certified for test administration by the Neurocognitive Core lab personnel.

    Measured: 3 months and 12 months

  11. Length of Stay

    Length of stay of index hospitalization

    Measured: up to 12 months

  12. Hospitalizations

    Frequency and cause of readmissions

    Measured: up to 12 months

  13. Hospital Costs

    Hospital resource use

    Measured: up to 12 months

  14. Functional Status

    functional status, defined by the number of temporary weans from LVAD support tolerated

    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 posted13 Feb 2015 (estimated)
  2. Study startJul 2015
  3. Primary completion10 Aug 2018
  4. Study completion23 Aug 2019

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
159 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02362646
Sponsor's protocol ID
GCO 08-1078-0008
Other IDs
2U01HL088942-07
Status last verified
Nov 2019
First submitted
9 Feb 2015
Last updated
26 Nov 2019
Data monitoring committee
Yes

Publications

  • Yau TM, Pagani FD, Mancini DM, Chang HL, Lala A, Woo YJ, Acker MA, Selzman CH, Soltesz EG, Kern JA, Maltais S, Charbonneau E, Pan S, Marks ME, Moquete EG, O'Sullivan KL, Taddei-Peters WC, McGowan LK, Green C, Rose EA, Jeffries N, Parides MK, Weisel RD, Miller MA, Hung J, O'Gara PT, Moskowitz AJ, Gelijns AC, Bagiella E, Milano CA; Cardiothoracic Surgical Trials Network. Intramyocardial Injection of Mesenchymal Precursor Cells and Successful Temporary Weaning From Left Ventricular Assist Device Support in Patients With Advanced Heart Failure: A Randomized Clinical Trial. JAMA. 2019 Mar 26;321(12):1176-1186. doi: 10.1001/jama.2019.2341.

    PubMed 30912838

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MPC Intramyocardial Injection in people with Heart Failure and Cardiomyopathy, run by Annetine Gelijns at 19 sites in 2 countries.

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 6 inclusion and 21 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: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 sites in United States, Canada. 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 26 Nov 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?

Number of Temporary Weans From LVAD Support Tolerated (time frame: up to 6 months). The study lists 2 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 NCT02362646, which also lists 1 linked publication.

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 26 Nov 2019.

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