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The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01442129
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : October 13, 2014
Last Update Posted : May 1, 2015
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Deborah Ascheim, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE September 26, 2011
First Posted Date  ICMJE September 28, 2011
Results First Submitted Date  ICMJE October 7, 2014
Results First Posted Date  ICMJE October 13, 2014
Last Update Posted Date May 1, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 26, 2011)
Intervention Related Adverse Events [ Time Frame: 90 days ]
The primary safety endpoint of this study is the incidence of the following potential study-intervention related adverse events within 90 days post intervention (LVAD implantation + intramyocardial injection of study product): infectious myocarditis, myocardial rupture, neoplasm, hypersensitivity reaction, and immune sensitization.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 7, 2014)
Functional Status and Ventricular Function [ Time Frame: 90 days ]
The key efficacy endpoint of this study is functional status and ventricular function, while weaned from LVAD support, at 90 days post intervention (LVAD implantation + intramyocardial injection of study product). Functional status is defined by the ability to tolerate wean from LVAD support for 30 minutes without signs or symptoms of hypoperfusion, including, but not limited to symptoms of low output or signs of vascular congestion. Ventricular function will be assessed by transthoracic echocardiogram (TTE) in those patients able to be weaned for 30 minutes from LVAD support. The number of participants who successfully tolerated the 30 minute wean from LVAD support at 90 days is reported.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 26, 2011)
Functional Status and Ventriciular Function [ Time Frame: 90 days ]
The key efficacy endpoint of this study is functional status and ventricular function, while weaned from LVAD support, at 90 days post intervention (LVAD implantation + intramyocardial injection of study product). Functional status is defined by the ability to tolerate wean from LVAD support for 30 minutes without signs or symptoms of hypoperfusion, including, but not limited to symptoms of low output or signs of vascular congestion. Ventricular function will be assessed by transthoracic echocardiogram (TTE) in those patients able to be weaned for 30 minutes from LVAD support.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function in Patients Undergoing LVAD Implantation
Official Title  ICMJE LVAD Therapy: Exploring the Effect of Intramyocardial Injection of Mesenchymal Precursor Cells on Myocardial Function
Brief 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. 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.
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, as well as 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. If safety is established and an efficacy signal is observed in this exploratory trial, then the investigators will design a follow-up trial (stage 2) based on an adaptive design. The next trial would randomize patients to active therapy at one of two doses (25 and 75 million MPCs) versus placebo, and based on a predetermined selection criterion drop randomization to one of the dose arms as results accrue. Should this exploratory trial demonstrate safety but no signal of efficacy, then the subsequent trial would be based on a single dose of 75 million MPCs versus placebo.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Heart Failure
  • Cardiomyopathy
  • Ventricular Dysfunction
Intervention  ICMJE
  • Biological: MPC Intramyocardial injection
    Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation
    Other Name: RevascorTM
  • Biological: Control Solution
    Injection of control solution during the LVAD implantation.
    Other Name: Cryoprotective media
Study Arms  ICMJE
  • Experimental: MPC Intramyocardial injection
    Intramyocardial injections of 25 million Mesenchymal Precursor Cells (MPCs)
    Intervention: Biological: MPC Intramyocardial injection
  • Sham Comparator: Control Solution
    Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO
    Intervention: Biological: Control Solution
Publications * Ascheim DD, Gelijns AC, Goldstein D, Moye LA, Smedira N, Lee S, Klodell CT, Szady A, Parides MK, Jeffries NO, Skerrett D, Taylor DA, Rame JE, Milano C, Rogers JG, Lynch J, Dewey T, Eichhorn E, Sun B, Feldman D, Simari R, O'Gara PT, Taddei-Peters WC, Miller MA, Naka Y, Bagiella E, Rose EA, Woo YJ. Mesenchymal precursor cells as adjunctive therapy in recipients of contemporary left ventricular assist devices. Circulation. 2014 Jun 3;129(22):2287-96. doi: 10.1161/CIRCULATIONAHA.113.007412. Epub 2014 Mar 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 26, 2011)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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 implantable, non-pulsatile LVAD as a bridge to transplantation or for destination therapy.

Exclusion Criteria:

  • Planned percutaneous LVAD implantation;
  • Anticipated requirement for biventricular mechanical support;
  • Cardiothoracic surgery within 30 days prior to randomization;
  • Myocardial infarction within 30 days prior to randomization;
  • 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;
  • Active systemic infection within 48 hours prior to randomization;
  • Presence of >10% anti-human leukocyte antigen (anti-HLA) antibody titers with known specificity to the MPC donor HLA antigens;
  • A 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);
  • Received investigational intervention within 30 days prior to randomization;
  • Treatment and/or an incompleted 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01442129
Other Study ID Numbers  ICMJE GCO 08-1078-00006
U01HL088942 ( U.S. NIH Grant/Contract )
U01HL088942-04 ( U.S. NIH Grant/Contract )
711 ( Other Identifier: Ct Surgery Network Research Group )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Deborah Ascheim, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Deborah Ascheim
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Study Chair: Timothy Gardner, MD Christiana Care Health Services
Study Chair: Patrick O'Gara, MD Brigham and Women's Hospital
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP