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Adult Stem Cell Trial Approved By Royal Melbourne Hospital For Orthopaedic Use

10/19/2005 5:12:41 PM

MELBOURNE, Australia, Sept. 22 /PRNewswire-FirstCall/ -- Australian adult stem cell company, Mesoblast Limited , 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 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

Mesoblast Limited

CONTACT: Julie Meldrum, Corporate Communications Director of MesoblastLimited, +61-3-9639-6036,

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