MELBOURNE, Australia,
Aug. 22, 2011 /PRNewswire/ --
Regenerative medicine company, Mesoblast Limited (ASX:MSB), today
announced that the first minimally-invasive lumbar disc procedure
had been successfully performed in the Phase 2 clinical trial of
its proprietary adult Mesenchymal Precursor Cell (MPC) product for
the treatment of low back pain and degenerative disc disease. The
outpatient procedure lasted less than 20 minutes, with the patient
fully awake and under light sedation. The patient was shortly
discharged and there were no complications.
The procedure was undertaken by leading spine surgeon,
Kenneth Pettine, M.D., at the Spine
Institute and Loveland Surgery Center in Colorado, a United States Spine Center of
Excellence. Dr Pettine is a founder of the Spine Institute, an
international leader in non-fusion surgery of the spine, and the
co-inventor of Medtronic's Maverick artificial lumbar disc
device.
"This marks the third renaissance in spine care," Dr Pettine
said. "The first was improved diagnosis using Magnetic Resonance
Imaging (MRI), the second was end-stage replacement with artificial
discs, and now there is the potential widespread use of adult stem
cells for disc repair and regeneration."
Up to 15 percent 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 ongoing
progression of disc degeneration, the only option is major back
surgery involving artificial disc replacement or spinal fusion.
Both types of surgery are associated with significant risks,
and the avoidance of surgery is a major objective of new treatments
for degenerative disease of the spine.
In preclinical trials, a single minimally invasive injection of
Mesoblast's allogeneic MPCs into severely damaged intervertebral
discs resulted in significant reversal of the degenerative process,
regrowth of disc cartilage, and sustained normalization of disc
pathology, anatomy and function for at least six months.
Building on these results, Mesoblast aims to show that a single
minimally-invasive injection of its allogeneic or off-the-shelf
disc repair MPC product can regenerate damaged discs, thereby
reducing pain, improving function, and avoiding surgery.
Mesoblast's Phase 2 trial, which was cleared by the United
States Food and Drug Administration (FDA) last month, will enroll
100 patients with chronic low back pain due to lumbar disc
degeneration in 15 centers across the
United States and Australia, comparing outcomes at six months in
60 patients receiving MPC injections against 40 patients receiving
control injections.
"There is a significant need for a minimally invasive biological
solution to repair the degenerating disc, reduce back pain, improve
function, and eliminate the need for surgery. Mesoblast's adult
stem cell product could find broad use in the treatment of both
early and late degenerative disc disease, and could additionally
reduce spine surgery for this condition by as much as 80 percent,"
Dr Pettine added.
Mesoblast Limited
Mesoblast Limited (ASX: MSB; OTC ADR: MBLTY) is a world leader
in the development, manufacture, and commercialization of biologic
products for the broad field of regenerative medicine.
Mesoblast has the worldwide exclusive rights to 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 Director
T: +613 9639 6036
E: julie.meldrum@mesoblast.com
SOURCE Mesoblast Limited
