Mesoblast's Cell Therapy Strengthens Native Heart Function In Patients With End-Stage Heart Failure on Assisted Circulatory S...
November 18 2013 - 6:14PM
Patients with end-stage or New York Heart Association (NYHA) class
IV heart failure who receive a surgically implanted left
ventricular assist device (LVAD) heart pump to maintain circulation
may obtain specific benefit to their native heart from a single
dose of Mesoblast's proprietary mesenchymal precursor cells (MPCs)
injected directly into their heart during surgery, a multicenter
team of researchers within the United States National Institutes of
Health (NIH)-funded Cardiothoracic Surgical Trials Network (CTSN),
led by Icahn School of Medicine at Mount Sinai, New York, have
found.
The researchers reported that a single injection into the native
heart of 25 million allogeneic, or "off-the-shelf", MPCs resulted
in an improvement in cardiac function at the pre-specified key
efficacy endpoint of 90 days, as measured by the ability of the
native heart to support the circulation with the LVAD temporarily
turned down.
The results of the Phase 2 trial assessing the safety and
efficacy of injecting a single dose of MPCs directly into the heart
muscle of end-stage heart failure patients receiving an LVAD for
either bridge-to-transplant or as a destination therapy were
presented on 18 November at the American Heart Association
Scientific Sessions 2013 being held in Dallas, Texas; (Abstract
19673): Intramyocardial Injection of Allogeneic Mesenchymal
Precursor Cells in Left Ventricular Assist Device Patients.
The double-blind, placebo-controlled multicenter trial was
performed across 11 sites in the United States, and randomized 30
end-stage heart failure patients 2:1 to receive either a single 25
million dose injection of MPCs or control media into the native
heart at the time of LVAD implantation. LVAD weaning, defined as a
transient reduction in pump speed for at least 20 minutes, was
attempted in all patients at predetermined intervals to assess
native myocardial function. Patients were followed for one year or
until heart transplantation, whichever came first.
Key findings were:
- Improved cardiac function at 90 days: at the trial's 90-day key
efficacy endpoint, 50% MPC treated patients were able to tolerate
being temporarily weaned from their LVADs compared with 20%
controls.
- Improved early survival: at the trial's 90-day primary
endpoint, 0/20 MPC treated LVAD patients died compared with 3/10
(30%) controls.
- Improved cardiac function was sustained over the 12-month
follow-up period: 85% of MPC-treated LVAD patients were weaned
successfully on multiple occasions compared with 40% of
controls.
- There were no cell-related serious adverse events noted.
- There was no difference in human leukocyte antigen (HLA)
sensitization between MPC treated and control groups.
"These clinical trial results provide important data about the
safety and potential efficacy of a single MPC injection at the time
of LVAD implantation," said the study's lead author Dr Deborah
Ascheim, Associate Professor of Health Evidence and Policy and
Cardiology at Icahn School of Medicine at Mount Sinai, who serves
as Co-Director of the Data and Clinical Coordinating Center based
at Mount Sinai for the NIH-sponsored CTSN who conducted the
clinical trial study in collaboration with the Cardiovascular Cell
Therapy Research Network.
"These mesenchymal precursor cells have shown their potential to
safely facilitate early heart tissue repair in advanced heart
failure. We look forward to investigating the benefits of
this cell therapy further," Dr Ascheim commented.
According to the American Heart Association, 5.7 million
Americans have chronic congestive heart failure, with about 10% of
these with advanced or class IV heart failure.
Mesoblast Chief Executive Silviu Itescu said: "We are very
encouraged by the data presented at the American Heart Association
meeting by the independent researchers conducting the NIH-sponsored
Phase 2 trial. NYHA class IV heart failure patients represent
a substantial population for whom there are currently no
alternatives other than assisted circulatory support by LVADs or
heart transplantation.
"The results suggest that our MPCs may be effective in patients
with advanced or NYHA class IV heart failure, and we intend to
conduct further studies in this important group. This is in
addition to patients with class II and III heart failure who have
been shown to benefit from our MPCs in an earlier Phase 2 trial
using catheter-based cell delivery."
Recently, the United States Food and Drug Administration cleared
commencement of a Phase 3 trial of MPCs in patients with NYHA class
II or III chronic congestive heart failure after filing of an
Investigational New Drug application by Mesoblast's development and
commercialization partner Teva Pharmaceutical Industries Ltd.
About Mesoblast
Mesoblast Limited (ASX:MSB;USOTC:MBLTY) is a world leader in the
development of biologic products for the broad field of
regenerative medicine. The Company's proprietary technologies
include its Mesenchymal Precursor Cell and culture-expanded
Mesenchymal Stem Cell technology platforms, Dental Pulp Stem Cells
and expanded Hematopoietic Stem Cells. Mesoblast's allogeneic or
'off-the-shelf' regenerative medicine products are being developed
for the treatment of conditions with significant unmet medical
needs. The lead product candidates use its mesenchymal lineage
cells in four major and distinct areas - systemic inflammatory
conditions, cardiovascular diseases, orthopedic diseases of the
spine, and oncology conditions. www.mesoblast.com
CONTACT: Julie Meldrum
Corporate Communications
Mesoblast Limited
T: +61 (0) 3 9639 6036
E: julie.meldrum@mesoblast.com
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