Efficacy and Safety of Allogeneic Mesenchymal Precursor Cells (Rexlemestrocel-L) for the Treatment of Heart Failure. - Full Text View

Purpose

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	Intervention	Phase
Chronic Heart Failure	Biological: Allogeneic Mesenchymal Precursor Cells (MPC) Other: Sham Comparator	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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)

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by Mesoblast, Ltd. ( Mesoblast, Inc. ):

Primary Outcome Measures:

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:

Total hospital admissions for non-fatal recurrent decompensated HF events [ Time Frame: 12 Month minimum ]
Total hospital admissions or urgent HF visits for non-fatal decompensated HF [ Time Frame: 12 Month minimum ]
Length of in-hospital stay in intensive care unit for decompensated HF [ Time Frame: 12 Month minimum ]
Rate of non-fatal recurrent decompensated HF events resulting in hospitalization or urgent HF visits [ Time Frame: 12 Month minimum ]
Cardiac survival (captures only cardiac deaths) [ Time Frame: 12 Month minimum ]
Overall survival (captures all cause deaths) [ Time Frame: 12 Month minimum ]
Time-to-first HF-MACE [ Time Frame: 12 Month minimum ]
Time-to-death from cardiovascular causes [ Time Frame: 12 Month minimum ]
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 ]
LV remodeling in LVEDV determined by 2-D echocardiography [ Time Frame: Baseline, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
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 ]
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 ]
Functional status by New York Heart Association (NYHA) class [ Time Frame: Baseline, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
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 ]
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 ]
Time-to-terminal HF-MACE [ Time Frame: Minimum 12 months ]
Safety and tolerability of rexlemestrocel-L will be assessed throughout the study [ Time Frame: Minimum 12 months ]
Pharmacodynamics Studies Measures [ Time Frame: Baseline, months 3, 6, 12 and every 12 months thereafter until study conclusion ]
Pharmacogenomics (PGx) Analysis [ Time Frame: Screening ]
Immunogenicity Measures [ Time Frame: Screening, day 10, months 1, 3, 6, and 12, and every 6 months during study conduct ]
Exploratory Measures [ Time Frame: Protocol specified time points during the course of the study ]


Estimated Enrollment:	600
Study Start Date:	January 2014
Estimated Study Completion Date:	February 2019
Estimated Primary Completion Date:	February 2018 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	January 8, 2014
Last Updated:	October 27, 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

ClinicalTrials.gov processed this record on July 28, 2017

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