Spinal procedures:

Australian regenerative medicine
company, Mesoblast Limited   received
clearance from the FDA  for a Phase 2
clinical trial of its allogeneic or
"off-the-shelf" adult stem cells in
minimally invasive lumbar spinal fusion

The 24-patient trial, based at multiple
US sites, is comparing the
effectiveness and safety of two low
doses of Mesoblast's product,
NeoFuse, with autograft (patient's own
hip bone) in minimally-invasive surgery
for fusion of the lumbar spine.

Over 500,000 spinal fusion procedures
are performed annually in the US
alone. A minimally-invasive posterior or
lateral interbody approach is the
preferred procedure by surgeons in
around 80 per cent of lumbar spinal
fusions, with autograft remaining the
FDA's gold standard for this indication,
despite drawbacks such as graft pain
and infection.

Preclinical trials of NeoFuse in
minimally-invasive spinal fusion
surgery showed that a lower dose than
has previously been used in the
lumbar spine resulted in significantly
earlier bony fusion over three to six
months compared with autograft,
without any safety issues. If these
results are confirmed in the clinical
trial, this would significantly reduce
cost of goods and increase product
net revenues.

Because of significant safety issues,
competitor biologic technologies have
not been able to gain FDA approval for
use in this preferred type of minimally
invasive lumbar fusion surgery. The
minimally invasive lumbar fusion trial
will build on the safety and efficacy
results generated to date in
Mesoblast's first spinal fusion trial that
employed a more invasive surgical
approach. In that trial, unilateral use of
Mesoblast's NeoFuse has been shown
to generate safe and robust fusion
over a 12-month period.

If similar results are obtained in the
minimally invasive trial, this will open a
major commercial opportunity for
Mesoblast. After establishing safety
and effectiveness during the conduct
of this trial, Mesoblast plans to initiate
a pivotal/Phase 3 trial to register its
"off-the-shelf" product for the lucrative
minimally-invasive lumbar spinal fusion
surgery market.

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