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

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: NCT02032004
Recruitment Status : Completed
First Posted : January 9, 2014
Last Update Posted : January 10, 2022
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Study Description
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Brief Summary:
The primary objective of this study is to determine whether transendocardial delivery of allogeneic human bone marrow-derived mesenchymal precursor cells (MPCs [rexlemestrocel-L]) is effective in the treatment of chronic heart failure (HF) due to left ventricular (LV) systolic dysfunction.

Condition or disease Intervention/treatment Phase
Chronic Heart Failure Biological: Allogeneic Mesenchymal Precursor Cells (MPCs) 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 (heart failure major adverse cardiac events [HF-MACE]), preventing further adverse cardiac remodeling (left ventricular end systolic volume [LVESV] and left ventricular end-diastolic volume [LVEDV]), and increasing exercise capacity (six-minute walking test [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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 566 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 : February 14, 2014
Actual Primary Completion Date : May 29, 2020
Actual Study Completion Date : May 29, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arms and Interventions
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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 (MPCs)
Rexlemestrocel-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:
  • MPCs
  • 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.


Outcome Measures
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Primary Outcome Measures :
  1. Time to recurrent non-fatal decompensated heart failure major adverse cardiac events (HF-MACE) that occur prior to the first terminal cardiac event (TCE). [ Time Frame: 6 Month minimum ]

Secondary Outcome Measures :
  1. Time-to-first terminal cardiac event (TCE) [ Time Frame: 6 Month minimum ]
  2. Time-to-hospital admissions for non-fatal decompensated HF events [ Time Frame: 6 Month minimum ]
  3. Time-to-urgent care outpatient HF visits [ Time Frame: 6 Month minimum ]
  4. Time-to-successfully resuscitated cardiac death (RCD) events [ Time Frame: 6 Month minimum ]
  5. Total length of in-hospital stay in intensive care unit for non-fatal decompensated HF events [ Time Frame: 6 Month minimum ]
  6. Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, and successfully RCD events) [ Time Frame: 6 Month minimum ]
  7. Time-to-first HF-MACE (composite of hospital admissions for decompensated HF, urgent care outpatient HF visit, successfully RCD events or TCE) [ Time Frame: 6 Month minimum ]
  8. Time-to-cardiac death [ Time Frame: 6 Month minimum ]
  9. Time-to-all-cause death [ Time Frame: 6 Month minimum ]
  10. Time-to-first non-fatal MI (myocardial infarction), non-fatal CVA (cerebrovascular attack) or coronary artery revascularization [ Time Frame: 6 Month minimum ]
  11. Left Ventricular (LV) remodeling in LVESV determined by 2-D echocardiography [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
  12. Correlations between baseline LVESV <=100 mL and LVESV >100 mL and clinical outcomes [ Time Frame: 6 Month minimum ]
  13. Correlations between baseline LVESV <=100 mL and LVESV >100 mL and change in Month 6 to baseline LVESV and clinical outcomes [ Time Frame: 6 Month minimum ]
  14. LV remodeling in LVEDV determined by 2-D echocardiography [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
  15. Overall Left Ventricular systolic performance as assessed by left ventricular ejection fraction (LVEF [radionuclide ventriculography {RVG} or echocardiogram]) [ Time Frame: Screening, day 0 (post-procedure), months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
  16. Functional exercise capacity as assessed by 6 Minute Walk Test [ Time Frame: Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
  17. Functional status by New York Heart Association (NYHA) class [ Time Frame: Screening, months 3, 6, and 12, and every 12 months thereafter during study conduct (6 Month minimum) ]
  18. Quality of Life Measure - Minnesota Living With Heart Failure (MLHF) questionnaire [ Time Frame: Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  19. Quality of Life Measure - European Quality of Life (EuroQoL) 5-dimensional (EQ-5D) questionnaire [ Time Frame: Screening, months 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  20. Safety as assessed by occurrence of adverse events related to the index cardiac catheterization on Day 0 [ Time Frame: Day 0 through discharge from Day 0 hospitalization ]
  21. Safety as assessed by occurrence of treatment-emergent adverse events [ Time Frame: Screening through 6 Month minimum ]
  22. Safety as assessed by clinical laboratory tests (serum chemistry - ALT, AST, alkaline phosphate, GGT, LDH, BUN, creatinine, uric acid, total bilirubin - and hematology - hematocrit, hemoglobin, WBCs, eosinophils, ANC, platelet count) [ Time Frame: Screening, day 0 (post-procedure), day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
    ALT (alanine transaminase), AST (aspartate aminotransferase), GGT (gamma-glutamyl transferase), LDH (lactate dehydrogenase), BUN (blood urea nitrogen), WBCs (white blood cells), ANC (absolute neutrophil count)

  23. Safety as assessed by urinalysis (blood, glucose, ketones, total protein) [ Time Frame: Screening, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  24. Safety as assessed by vital signs (pulse, systolic blood pressure [BP], diastolic BP) [ Time Frame: Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  25. Safety as assessed by 12-lead electrocardiogram (ECG) findings - QT interval with Fridericia's correction (QTcF), heart rate-corrected QT interval (QTcB), QT, Q wave, R wave and S wave (QRS) complex, HR and T waves. [ Time Frame: Screening, day 0 (pre and post-procedure), day 1, day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  26. Safety as assessed by telemetry monitoring findings (clinically significant arrhythmias) [ Time Frame: Day 0 through Day 0 overnight post-procedure ]
  27. Safety as assessed by rhythm analysis (specifically, ventricular arrhythmias) by interrogation of any implanted device capable of defibrillation [ Time Frame: Day 10, months 1, 3, 6, and 12, and every 6 months thereafter during study conduct (6 Month minimum) ]
  28. Safety as assessed by 24-hr Holter monitoring (HR, rate & duration of arrhythmias, a-fib average rate, supra- & ventricular ectopy singles/couplets/runs/totals, sustained & non-sustained ventricular tachycardia, longest pauses RR duration, total pauses) [ Time Frame: Screening, day 0 (post-procedure), day 10, months 1 and 3 ]
  29. Safety as assessed by physical examination findings judged as clinically significant changes from baseline by the investigator or newly occurring abnormalities (including weight) [ Time Frame: Screening, month 12 and every 12 months thereafter until study conclusion (weight measured at screening, day 0 - pre and post-procedure, day 1, day 10, months 1, 3, 6 and 12 and every 6 months thereafter) ]
  30. Safety as assessed by important cardiovascular events from adjudicated data [ Time Frame: 6 Month minimum ]

Other Outcome Measures:
  1. Pharmacodynamics Measures (N-terminal (NT)-pro hormone BNP [NT-proBNP] and high-sensitivity C-reactive protein [hs-CRP]) [ Time Frame: Screening, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
  2. Pharmacogenomics (PGx) Analysis [ Time Frame: Screening (only from those subjects who provide consent to participate in PGx sample collection) ]
  3. Immunogenicity Measures (panel reactive antibodies, donor specific antibody, if panel-reactive antibody (PRA) test is positive, antibodies against bovine and murine products) [ Time Frame: Screening, day 10, months 1, 3, 6, and 12 ]

Eligibility Criteria
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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
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Mesoblast, Inc.
Investigators
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Study Director: Fred Grossman, DO Mesoblast, Ltd.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mesoblast, Inc.
ClinicalTrials.gov Identifier: NCT02032004    
Other Study ID Numbers: MSB-MPC-CHF001
First Posted: January 9, 2014    Key Record Dates
Last Update Posted: January 10, 2022
Last Verified: January 2022
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:
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Heart Failure
Heart Diseases
Cardiovascular Diseases