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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 : October 31, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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)
Study Start Date : January 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arms and Interventions

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.


Outcome Measures

Primary Outcome Measures :
  1. Time to non-fatal recurrent first 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 [ 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, 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 and 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: Minimum 12 months ]
  17. Safety and tolerability of rexlemestrocel-L will be assessed throughout the study [ Time Frame: Minimum 12 months ]
  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: Screening, 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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

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: inVentiv Health
Contact: Aimee M Barrera +1 919 602 5311 mailto:aimee.barrera@inventivhealth.com

  Show 58 Study Locations
Sponsors and Collaborators
Mesoblast, Inc.
Investigators
Study Chair: Donna Skerrett, MD Mesoblast, Ltd.
More Information

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: October 31, 2016
Last Verified: October 2016
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