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Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure. (DREAM HF-1)

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ClinicalTrials.gov Identifier: NCT02032004
Recruitment Status : Recruiting
First Posted : January 9, 2014
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Brief Summary:
The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived MPCs (rexlemestrocel-L) is effective in the treatment of chronic heart failure due to LV systolic dysfunction.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Biological: Allogeneic Mesenchymal Precursor Cells (MPC) Other: Sham Comparator Phase 3

Detailed Description:
The purpose of this study is to evaluate the efficacy and safety of a single transendocardial delivery in the cardiac catheterization laboratory of human bone marrow-derived allogeneic MPCs (rexlemestrocel-L) for improvement in clinical outcomes (HF-MACE), preventing further adverse cardiac remodeling (LVESV and LVEDV), and increasing exercise capacity (6MWT) in patients with chronic HF due to LV systolic dysfunction of either ischemic or nonischemic etiology who have received optimal medical/revascularization therapy.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-blind, Randomized, Sham-procedure-controlled, Parallel-Group Efficacy and Safety Study of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) in Chronic Heart Failure Due to LV Systolic Dysfunction (Ischemic or Nonischemic) Dream HF-1
Actual Study Start Date : January 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: Allogeneic Mesenchymal Precursor Cells
Participants randomly assigned to treatment will undergo a single index cardiac catheterization involving transendocardial delivery of rexlemestrocel-L into the myocardium at a cell injection center by an interventional cardiology team not involved with review or assessment of subsequent study results.
Biological: Allogeneic Mesenchymal Precursor Cells (MPC)
Rexlemestrolcel-L consists of human bone marrow-derived allogeneic MPCs isolated from bone mononuclear cells with anti-STRO-3 antibodies, expanded ex vivo,and cryopreserved
Other Names:
  • MPC
  • rexlemestrocel-L

Sham Comparator: Control Treatment
Participants randomly assigned to control treatment will undergo a single cardiac catheterization involving a scripted sham cardiac mapping and cell delivery procedure at a cell injection center by an interventional cardiology team not involved with review or assessment of subsequent study results.
Other: Sham Comparator
The sham procedure will be staged to script and will not include actual cardiac mapping or delivery of rexlemestrocel-L.




Primary Outcome Measures :
  1. Time to non-fatal recurrent decompensated heart failure (HF) events in the presence of terminal HF-related major adverse cardiac events (HF-MACE) [ Time Frame: 12 Month minimum ]

Secondary Outcome Measures :
  1. Total hospital admissions for non-fatal recurrent decompensated HF events [ Time Frame: 12 Month minimum ]
  2. Total hospital admissions or urgent HF visits for non-fatal decompensated HF [ Time Frame: 12 Month minimum ]
  3. Length of in-hospital stay in intensive care unit for decompensated HF [ Time Frame: 12 Month minimum ]
  4. Rate of non-fatal recurrent decompensated HF events resulting in hospitalization or urgent HF visits hospitalization or urgent HF visits [ Time Frame: 12 Month minimum ]
  5. Cardiac survival (captures only cardiac deaths) [ Time Frame: 12 Month minimum ]
  6. Overall survival (captures all cause deaths) [ Time Frame: 12 Month minimum ]
  7. Time-to-first HF-MACE [ Time Frame: 12 Month minimum ]
  8. Time-to-death from cardiovascular causes [ Time Frame: 12 Month minimum ]
  9. Left Ventricular remodeling in LVESV determined by 2-D echocardiography [ Time Frame: Baseline, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
  10. LV remodeling in LVEDV determined by 2-D echocardiography [ Time Frame: Baseline, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
  11. Overall Left Ventricular systolic performance performance as assessed by LVEF (RVG or echocardiogram) [ Time Frame: Baseline and months 3, 6, 12 and every 12 months thereafter until study conclusion ]
  12. Functional exercise capacity as assessed by 6 Minute Walk Test [ Time Frame: Baseline, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
  13. Functional status by New York Heart Association (NYHA) class [ Time Frame: Baseline, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
  14. Quality of Life Measure - Minnesota Living With Heart Failure (MLHF) questionnaire [ Time Frame: Baseline, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
  15. Quality of Life Measure - EuroQoL 5-dimensional (EQ-5D) questionnaire [ Time Frame: Baseline, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
  16. Time-to-terminal HF-MACE [ Time Frame: 12 Month minimum ]
  17. Safety and tolerability of rexlemestrocel-L will be assessed throughout the study [ Time Frame: 12 Month minimum ]
  18. Pharmacodynamics Studies Measures [ Time Frame: Baseline, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
  19. Pharmacogenomics (PGx) Analysis [ Time Frame: Screening ]
  20. Immunogenicity Measures [ Time Frame: Baseline, day 10, months 1, 3, 6, and 12, and every 6 months during study conduct ]
  21. Exploratory Measures [ Time Frame: Protocol specified time points during the course of the study ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The patient is 18 to 80 years of age, inclusive; both men and women will be enrolled.
  • The patient has a diagnosis of chronic HF of ischemic or nonischemic etiology for at least 6 months
  • The patient is on stable, optimally tolerated dosages of HF therapies including beta-blockers (approved for country-specific usage), angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and/or aldosterone antagonists, without change in dose for at least 1 month before study intervention
  • The patient is on a stable, outpatient, oral diuretic dosing regimen in which the patient remains clinically stable during screening.
  • Other Criteria apply, please contact the investigator

Exclusion Criteria:

  • The patient has NYHA Functional Class I or Functional Class IV symptoms.
  • Other Criteria apply, please contact the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032004


Contacts
Contact: Syneos Health
Contact: Aimee Barrera, Associate Project Director +1 919 602 5311 aimee.barrera@syneoshealth.com

  Hide Study Locations
Locations
United States, Alabama
Mesoblast Investigational Site 10757 - Cardiology, P.C. Recruiting
Birmingham, Alabama, United States, 35211
Contact: Susan DeRamus       sderamus@cardiologypc.com   
Principal Investigator: Alain Bouchard, MD         
Mesoblast Investigational Site 13262 - University of Alabama at Birmingham Hospital Recruiting
Birmingham, Alabama, United States, 35233
Contact: Brittany Johnson       bejohnson@uabmc.edu   
Principal Investigator: Sumanth Prabhu, MD         
United States, Arizona
Mesoblast Investigational Site 10779 - Mercy Gilbert Medical Center Recruiting
Gilbert, Arizona, United States, 85297
Contact: Brian Mutoff       Brian.Mutoff@dignityhealth.org   
Principal Investigator: Anantharam Kalya, MD         
Mesoblast Investigational Site 10786 - Cardiovascular Associates of Mesa Recruiting
Mesa, Arizona, United States, 85206
Contact: Vonnie Fuentes       sfuentes@cvam.com   
Principal Investigator: Andrew Kaplan, MD         
Mesoblast Investigational Site 10756 - Mayo Clinic Recruiting
Phoenix, Arizona, United States, 85054
Contact: Megan Kelly       Kelly.Megan1@mayo.edu   
Principal Investigator: Robert Scott, MD         
Mesoblast Investigational Site 13023 - University of Arizona Medical Center Recruiting
Tucson, Arizona, United States, 85724
Contact: Catherine MacDonald       Cmacdonald@shc.arizona.edu   
Principal Investigator: Ranjith Shetty, MD         
United States, California
Mesoblast Investigational Site 10754 - University of California, San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Melanee Schimmel       mschimmel@ucsd.edu   
Principal Investigator: Eric Adler, MD         
Mesoblast Investigational Site 10759 - Scripps Clinic Recruiting
La Jolla, California, United States, 92037
Contact: Heather Catchpole       Catchpole.Heather@scrippshealth.org   
Principal Investigator: James Heywood, MD         
Mesoblast Investigational Site 13265 - University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90045
Contact: Ladda Douangvila       ldouangvila@mednet.ucla.edu   
Principal Investigator: Ali Nsair, MD         
Mesoblast Investigational Site 10775 - Cedars-Sinai Medical Care Foundation Recruiting
Los Angeles, California, United States, 90211
Contact: Maria Thottam       Maria.Thottam@cshs.org   
Principal Investigator: David Chang, MD         
Mesoblast Investigational Site 10778 - Orange County Cardiology Recruiting
Orange, California, United States, 92868
Contact: Karena De La Mora       kdelamora@ocheartinstitute.com   
Principal Investigator: Kelly Tucker, MD         
Mesoblast Investigational Site 13031 - St. John's Regional Medical Center Recruiting
Oxnard, California, United States, 93030
Contact: Lindsey McFarland       Lindsey.McFarland@DignityHealth.org   
Principal Investigator: Richard Rothschild, MD         
Mesoblast Investigational Site 13275 - Stanford University Hospital Recruiting
Stanford, California, United States, 94305
Contact: Divya Rajmohan       rajmohan@stanford.edu   
Principal Investigator: Phillip Yang, MD         
United States, Florida
Mesoblast Investigational Site 13267 - Bethesda Heart Hospital Recruiting
Boynton Beach, Florida, United States, 33435
Contact: Eric Marquez       emarquez@rpna.net   
Principal Investigator: Christina Michael, MD         
Mesoblast Investigational Site 10780 - Morton Plant Hospital Recruiting
Clearwater, Florida, United States, 33756
Contact: Terri Jones       teresa.jones@baycare.org   
Principal Investigator: Leslie Miller, MD         
Mesoblast Investigational Site 10760 - Shands Hospital, University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Nicole Bostick       Janette.bostick@medicine.ufl.edu   
Contact: Kasey Smith       Kasey.smith@medicine.ufl.edu   
Principal Investigator: Carl Pepine, MD         
Mesoblast Investigational Site 13273 - University of Florida Health Recruiting
Jacksonville, Florida, United States, 32209
Contact: Chauncey Smoot       Chauncey.Smoot@jax.ufl.edu   
Principal Investigator: Francesco Franchi, MD         
Mesoblast Investigational Site 10768 - University of Miami Recruiting
Miami, Florida, United States, 33215
Contact: Study Coordinators       ISCISStudyInfo@miami.edu   
Principal Investigator: Sandra Chaparro, MD         
Mesoblast Investigational Site 13280 Not yet recruiting
Orlando, Florida, United States
Contact: Aimee Barrera       aimee.barrera@syneoshealth.com   
Mesoblast Investigational Site 13264 - Florida Hospital Pepin Heart Institute Recruiting
Tampa, Florida, United States, 33613
Contact: Elizabeth Szymanski       Elizabeth.Szymanski@ahss.org   
Principal Investigator: Mohammadreza Tabesh, MD         
United States, Georgia
Mesoblast Investigational Site 13027 - Emory University School of Medicine Recruiting
Atlanta, Georgia, United States, 30322
Contact: Sher Shalman       ssher2@emory.edu   
Principal Investigator: David Markham, MD         
Mesoblast Investigational Site 10765 - Georgia Regents University Recruiting
Augusta, Georgia, United States, 30912
Contact: Sara Smith       SHOPKINS@augusta.edu   
Contact: Carol Smith       CSMITH@augusta.edu   
Principal Investigator: Neal Weintraub, MD         
United States, Illinois
Mesoblast Investigational Site 10772 - University Cardiologist, Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Nusrat Jahan       Nusrat_Jahan@rush.edu   
Principal Investigator: Dinesh Kalra, MD         
United States, Iowa
Mesoblast Investigational Site 13030 - University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Cynthia Larew       Cynthia-larew@uiowa.edu   
Principal Investigator: Linda Cadaret, MD         
United States, Kentucky
Mesoblast Investigational Site 10783 - Gill Heart Institute, University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Laura True       lauratrue@uky.edu   
Principal Investigator: Ahmed Abdel-Latif, MD         
Mesoblast Investigational Site 13022 - University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Anne Marie Webb       anne.webb@louisville.edu   
Principal Investigator: Emma Birks, MD         
United States, Louisiana
Mesoblast Investigational Site 13266 Completed
New Orleans, Louisiana, United States
United States, Massachusetts
Mesoblast Investigational Site 10782 Active, not recruiting
Boston, Massachusetts, United States
Mesoblast Investigational Site 13029 Withdrawn
Haverhill, Massachusetts, United States
United States, Michigan
Mesoblast Investigational Site 10766 - Michigan Cardiovascular Institute Recruiting
Saginaw, Michigan, United States, 48602
Contact: Val Bitzer       Valerie.bitzer@ascension.org   
Principal Investigator: Peter Fattal, MD, FACC         
United States, Minnesota
Mesoblast Investigational Site 10762 - Minneapolis Heart Institute Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Jane Fox       jane.fox@allina.com   
Principal Investigator: Mosi Bennett, MD         
Mesoblast Investigational Site 10761 - Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Dr. Barry Borlaug       Borlaug.Barry@mayo.edu   
Principal Investigator: Barry Borlaug, MD         
United States, Nevada
Mesoblast Investigational Site 13281 Not yet recruiting
Las Vegas, Nevada, United States
Contact: Aimee Barrera       aimee.barrera@syneoshealth.com   
United States, New Jersey
Mesoblast Investigational Site 13263 - RWJ Barnabas Heart Center Recruiting
Newark, New Jersey, United States, 07112
Contact: Dr. Saurabh Kapoor       Saurabh.kapoor@rwjbh.org   
Contact: Dr. Mark Zucker       Mark.zucker@rwjbh.org   
Principal Investigator: Saurabh Kapoor, MD         
United States, New York
Mesoblast Investigational Site 10776 - Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Danielle Brunjes, PhD       caccresearch@cumc.columbia.edu   
Principal Investigator: Maryjane Farr, MD         
United States, North Carolina
Mesoblast Investigational Site 13026 - Sanger Heart and Vascular Institute, Carolinas Healthcare System Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Susan McClain       Susan.mcclain@AtriumHealth.org   
Principal Investigator: Joseph Mishkin, MD         
Mesoblast Investigational Site 10781 - Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Alexis Sharp       alexis.sharp@duke.edu   
Principal Investigator: Thomas Povsic, MD         
United States, Ohio
Mesoblast Investigational Site 10758 - The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Karen Ibanez       karen.ibanez@thechristhospital.com   
Principal Investigator: Eugene Chung, MD         
Mesoblast Investigational Site 10770 - University of Cincinnati Recruiting
Cincinnati, Ohio, United States, 45267
Contact: Carol Knochelman       knochecl@UCMAIL.UD.EDU   
Principal Investigator: Vlad Cotarlan, DO         
Mesoblast Investigational Site 10773 Completed
Cleveland, Ohio, United States
Mesoblast Investigational Site 13278 - OhioHealth Research Institute Recruiting
Columbus, Ohio, United States, 43214
Contact: Kitra Hunter       Kitra.Hunter@Ohiohealth.com   
Principal Investigator: Anupam Basuray, MD         
United States, Pennsylvania
Mesoblast Investigational Site 10785 - Lehigh Valley Hospital Recruiting
Allentown, Pennsylvania, United States, 18103
Contact: Kristen Cornell       Kristen.Cornell@lvhn.org   
Principal Investigator: Ronald Freudenberger, MD         
Mesoblast Investigational Site 13261 - University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Patricia DiVito       Patricia.Divito@uphs.upenn.edu   
Principal Investigator: Brian Drachman, MD         
Mesoblast Investigational Site 10767 - Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Dr. Rene J. Alvarez, Jr.       rene.alvarez@tuhs.temple.edu   
Principal Investigator: Rene Alvarez, Jr., MD         
Mesoblast Investigational Site 13277 Not yet recruiting
Philadelphia, Pennsylvania, United States
Contact: Aimee Barrera       aimee.barrera@syneoshealth.com   
Mesoblast Investigational Site 10774 - University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Dr. Mark Simon       simonma@upmc.edu   
Principal Investigator: Marc Simon, MD, MS, FACC         
United States, Tennessee
Mesoblast Investigational Site 10777 - Stern Cardiovascular Foundation Recruiting
Germantown, Tennessee, United States, 38125
Contact: Brian Dragutsky       bdrag@sterncardio.com   
Principal Investigator: Frank McGrew, MD         
United States, Texas
Mesoblast Investigational Site 13024 - Austin Heart, PLLC Recruiting
Austin, Texas, United States, 78756
Contact: Lorie Tibbits       ltibbits@austinheart.com   
Principal Investigator: Roger Gammon, MD         
Mesoblast Investigational Site 13274 - Soltero CV Research Center, Baylor Scott & White Research Institute Recruiting
Dallas, Texas, United States, 75226
Contact: Pamela Coker       Pamela.Coker@BSWHealth.org   
Principal Investigator: Cara East, MD         
Mesoblast Investigational Site 13028 Withdrawn
Dallas, Texas, United States
Mesoblast Investigational Site 10755 - Texas Heart Institute Recruiting
Houston, Texas, United States, 77030
Contact: Sara Sampaio       ssampaio@texasheart.com   
Principal Investigator: Emerson Perin, MD, PhD         
Mesoblast Investigational Site 13268 - Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Mohamad G. Ghosn       mghosn@houstonmethodist.org   
Principal Investigator: Barry Trachtenberg, MD         
United States, Utah
Mesoblast Investigational Site 10763 - University Hospital Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Carlyn Sander       Carlyn.sander@hsc.utah.edu   
Principal Investigator: Craig Selzman, MD         
United States, Washington
Mesoblast Investigational Site 10771 - Heart & Vascular Research, Swedish Medical Center Recruiting
Seattle, Washington, United States, 98122
Contact: Charlene Boisjolie       charlene.boisjolie@swedish.org   
Principal Investigator: John Petersen II, MD         
Mesoblast Investigational Site 10788 Withdrawn
Tacoma, Washington, United States
United States, Wisconsin
Mesoblast Investigational Site 10764 - University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Leslie Gilbert       lgilbert@medicine.wisc.edu   
Principal Investigator: David Murray, MD, FACC         
Mesoblast Investigational Site 10769 - Aurora Healthcare Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Don Lobacz       donald.lobacz@aurora.org   
Principal Investigator: Nasir Sulemanjee, MD         
Mesoblast Investigational Site 13279 Not yet recruiting
Milwaukee, Wisconsin, United States
Contact: Aimee Barrera       aimee.barrera@syneoshealth.com   
Mesoblast Investigational Site 10789 - Aspirus Research Institute Recruiting
Wausau, Wisconsin, United States, 54401
Contact: Megan Johnson       Megan.Johnson@aspirus.org   
Principal Investigator: German Larrain, MD         
Canada, Alberta
Mesoblast Investigational Site 11027 Not yet recruiting
Edmonton, Alberta, Canada
Contact: Aimee Barrera       aimee.barrera@syneoshealth.com   
Canada, British Columbia
Mesoblast Investigational Site 11024 - Victoria Heart Institute Foundation Recruiting
Victoria, British Columbia, Canada, V8R 4R2
Contact: Noreen Lounsbury       nlounsbury@vhif.org   
Principal Investigator: Elizabeth Swiggum, MD         
Canada, Ontario
Mesoblast Investigational Site 11025 - St. Michael's Hospital Recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Maria Krisel Abulencia       AbulenciaMa@smh.ca   
Principal Investigator: Abdul Al-Hesayen, MD         
Sponsors and Collaborators
Mesoblast, Inc.
Investigators
Study Chair: Donna Skerrett, MD Mesoblast, Ltd.

Responsible Party: Mesoblast, Inc.
ClinicalTrials.gov Identifier: NCT02032004     History of Changes
Other Study ID Numbers: MSB-MPC-CHF001
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Mesoblast, Ltd. ( Mesoblast, Inc. ):
Chronic Heart Failure
CHF
Left Ventricular Systolic Dysfunction
Ischemic Heart Failure
Nonischemic Heart Failure
Stem Cells
Allogeneic Mesenchymal Precursor Cells

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases