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Leif
09-23-2005, 10:33 AM
http://afr.com/articles/2005/09/23/1126982222796.html


Sep 23 17:11
AAP



Biotech Mesoblast has won approval to start the first human trial of using adult stem cells to help mend broken bones. The pilot trial at the Royal Melbourne Hospital will assess the the safety of Mesoblast's specialist adult stem cell technology.

Pre-clinical studies have shown that Mesoblast's adult stem cell technology can generate new bone growth and new blood vessels without the need for additional surgical procedures and painful bone grafts.

Up to 10 patients suffering from unmended long bone fractures, which affect thousands of people each year in Australia, will participate in the trial.

Mesoblast executive chairman Michael Spooner said it would take eight to 10 weeks to recruit patients and get ready for the trial.

Leif
09-23-2005, 10:35 AM
http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/09-22-2005/0004113847&EDATE=


MELBOURNE, Australia, Sept. 22 /PRNewswire-FirstCall/ -- Australian adult
stem cell company, Mesoblast Limited (ASX: MSB), announced today approval to
commence the first human orthopaedic trial of Mesoblast's specialist adult
stem cell technology.
Approval from The Royal Melbourne Hospital's Human Research Ethics
Committee is for a Pilot Trial of up to 10 patients suffering from non-union
of long bone fractures, which affects up to two million people each year in
developed countries around the world.
The trial will be an independent assessment of the safety of Mesoblast's
specialist adult stem cell technology.
"The Royal Melbourne Hospital is excited to be at the forefront of this
world-leading technology and is keen to conduct an independent investigation
of the regenerative capabilities of Mesoblast's specialist adult stem cell
technology in humans," the Director of Orthopaedics at The Royal Melbourne
Hospital, Mr Richard de Steiger, said today.
The Pilot Trial's Principal Medical Investigator, Professor Stephen
Graves, said that enrolment could now begin with the first patients
anticipated to be recruited in the near future.
"Patients enrolled in the trial have limited options available to them and
have likely been through several previous procedures. In effect, this trial is
one of the very few remaining opportunities for patients to regain mobility in
their affected limbs.
"Preclinical studies have already shown that Mesoblast's specialist adult
stem cell technology can generate new bone growth and new blood vessels. Both
these outcomes appear to occur rapidly without the need for additional
surgical procedures and painful bone grafts," Professor Graves said.
Mesoblast Executive Chairman, Mr Michael Spooner, said the process
required to recruit patients and commence the clinical trial was expected to
take around eight to ten weeks. This period included harvesting, culturing and
expanding patient stem cells at the Peter MacCallum Cancer Institute's Cell
Therapies Pty Ltd in Melbourne under Good Manufacturing Practice conditions,
prior to implanting the expanded stem cells into the affected area of each
patient.
"Importantly, this trial is intended to target only one of a number of
substantial, unmet, orthopaedic illnesses and diseases which Mesoblast intends
to address and which affect the vast majority of us at some stage during our
lives.
"Significantly, current treatments for orthopaedic conditions are one of
the greatest costs to the international health community.
"Mesoblast's goal is to deliver a product to market that reduces the
overall cost of medical treatment and improve patient outcomes whilst
delivering profit margins to our shareholders usually obtained by
pharmaceutical companies," Mr Spooner said.

About Mesoblast
Mesoblast Limited (ASX: MSB) is an Australian biotechnology company
committed to the development of novel treatments for orthopaedic conditions,

including the commercialisation of a unique adult stem cell technology aimed
at the regeneration and repair of bone and cartilage.
Mesoblast, which listed on the Australian Stock Exchange in December 2004,
has the worldwide exclusive rights for a series of patents and technologies
that have been developed over more than 10 years and which relate to the
identification, extraction and culture of adult Mesenchymal Precursor Cells
(MPCs). The technology has achieved outstanding results in pre-clinical in
vivo studies in the regeneration and repair of large bone fractures. The
company has also acquired a 33.3% interest in Angioblast Systems Inc, an
American company developing the platform MPC technology for the treatment of
cardiovascular diseases, including repair and regeneration of blood vessels
and heart muscle. Mesoblast and Angioblast will jointly fund and progress the
core technology.

About Royal Melbourne Hospital
The Royal Melbourne Hospital is one of Victoria's leading public teaching
hospitals and a level one trauma centre, providing acute tertiary referral
service at its City site and aged care, rehabilitation, ambulatory care and
residential and community services at its Royal Park Campus.

For further information, please contact:

Julie Meldrum
Corporate Communications Director
Mesoblast Limited
61 3 9639 6036
julie.meldrum@mesoblast.com (julie.meldrum@mesoblast.com)
http://www.mesoblast.com (http://www.mesoblast.com/)