MELBOURNE, Australia,
April 17, 2012 /PRNewswire/ -- Global
regenerative medicine company Mesoblast Limited (ASX:MSB) today
announced that its Phase 2 clinical trial investigating the use of
allogeneic, or off-the-shelf, Mesenchymal Precursor Cells (MPCs)
for non-surgical restoration of degenerated intervertebral discs
and treatment of low back pain has enrolled 50% of the total study
patients. This rapid rate of enrolment attests to the major unmet
medical need and to the relative simplicity of Mesoblast's
non-surgical procedure. Mesoblast expects to complete full
enrolment by early third quarter.
Up to 15 per cent of people in industrialized countries have
chronic low back pain lasting more than six months. For those with
progressive, severe and debilitating pain due to degenerating
intervertebral discs, the only current option is major back surgery
involving spinal fusion, artificial disc replacement, or other
surgical procedures. Avoidance of surgery and its complications is
a major objective of any new treatment for degenerative disease of
the spine.
Mesoblast is developing a non-surgical adult stem cell treatment
for these patients using a simple intervertebral disc injection of
allogeneic MPCs that takes less than 15 minutes in an outpatient
setting. The Phase 2 clinical trial design, endpoints and dose
ranges are based on Mesoblast's successful preclinical study using
allogeneic sheep MPCs for non-surgical restoration of damaged
intervertebral discs.
Full results of Mesoblast's successful study were published in
the March 2012 issue of the Journal
of Neurosurgery, the premier peer-reviewed neurosurgical forum. The
scientific publication, entitled "Immunoselected STRO-3+mesenchymal
precursor cells and restoration of the extracellular matrix of
degenerate intervertebral discs", can be viewed at
http://thejns.org/doi/full/10.3171/2012.1.SPINE11852
The peer-reviewed publication showed that a single non-surgical
injection of Mesoblast's allogeneic MPCs into damaged
intervertebral discs resulted in significant regeneration of disc
anatomy, increase in proteoglycan content, and increase in disc
height, for at least six months. The lowest dose of MPCs caused the
damaged discs to become statistically equivalent to the
non-degenerated normal control discs at six months when evaluated
by MRI and histopathological analyses; in contrast, the degenerated
discs treated with nothing or the carrier control remained
statistically worse in each parameter tested than the
non-degenerated normal control discs.
Mesoblast's double-blind, placebo-controlled Phase 2 clinical
trial is being conducted at 15 sites across the United States, and will randomize a total
of 100 patients with intervertebral disc disease to receive a
non-surgical, percutaneous injection into the intervertebral disc
of either low or high dose MPCs with hyaluronic acid carrier,
hyaluronic acid carrier alone or saline alone. The trial aims to
extend Mesoblast's preclinical results, and show that a single MPC
injection can reduce low back pain and improve function over six
months, improve disc anatomy, and eliminate the need for a surgical
procedure.
About Mesoblast
Mesoblast Limited (ASX:MSB) is a world leader in commercialising
biologic products for the broad field of regenerative medicine.
Mesoblast has the worldwide exclusive rights for a series of
patents and technologies developed over more than 10 years relating
to the identification, extraction, culture and uses of adult
Mesenchymal Precursor Cells (MPCs). www.mesoblast.com
For further information, please contact:
Julie Meldrum
Corporate Communications
Mesoblast Limited
T: +61 (0) 3 9639 6036
E: julie.meldrum@mesoblast.com
SOURCE Mesoblast
