What is Stem Cell: [StemCells] Non-healing bone repaired in clinical trials

Non-Healing Bones Repaired In Clinical Trial Using Adult Stem Cells
06 Aug 2008 - 2:00 PDT

The Royal Melbourne Hospital and Australia's regenerative medicine
company, Mesoblast Limited (ASX:MSB)(PINK:MBLTY), jointly announced
successful results from the long bone fracture repair clinical trial
using Mesoblast's proprietary adult stem cell technology.

Ten patients with a total of 11 non-healing fractures of the long
bones in the legs (following road trauma in 8) were operated on using
Mesoblast's proprietary stem cells. After completing 12 months of
follow-up, eight achieved complete bony union post stem cell
implantation, and a ninth (with fractures of both the femur and
tibia) achieved bony union of the tibia only, within a median time of
4 months. These same patients had a non-united fracture for up to 41
months prior to cell implantation, with a median of 10 months.

! Of the 8 patients who had successful long bone union, all have!
been ab le to fully weight bear and resume daily activities. In these
patients, Mesoblast's technology eliminated the need for a second
operation to harvest bone from the pelvis. Equally as important, no
adverse events related to the stem cell therapy occurred during this
period. The remaining two patients had complex road trauma fractures
involving multiple bones, which required re-operation.

Principal Investigator and orthopaedic surgeon, Mr Richard de
Steiger, said the results were "exciting and underscore the extremely
bright future for this cutting-edge technology.

"The positive outcomes in this trial pave the way for randomised,
multi-centre clinical trials using Mesoblast's allogeneic or
unrelated donor cells.

"Good results are likely to be seen with allogeneic cells as there
should be reproducibility of outcomes and enhanced dosage
predictability using a batched product derived from a young, healthy
donor," Mr de Steiger said.

Mes! oblast's Executive Director, Professor Silviu Itescu, said that
Mesoblast's current focus is on Phase 2 Investigational New Drug
(IND) submissions to the United States Food and Drug Administration
(FDA) for the company's allogeneic stem cells in the treatment of non-
union and high-risk fresh fractures.

"These results clearly show that our proprietary stem cell technology
is safe and effective for speeding up bone fracture repair. There is
a clear need for a minimally invasive, highly effective therapy to
accelerate fracture repair and treat or prevent non-union, and we
believe that Mesoblast's technology is ideally suited to deliver such
a product," Professor Itescu said.

Tens of millions of people worldwide suffer from non-union long bone
fractures, a debilitating condition mainly associated with victims of
road accident trauma and which, in some cases, may result in limb
amputation. Many more patients suffer from severe fractures that heal
slowly or ! poorly and are at high risk for non-union. These
conditions re! present major costs to health authorities globally and
major commercial opportunities for Mesoblast.

About The Royal Melbourne Hospital

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

About Mesoblast Limited

Mesoblast Limited (ASX:MSB; USOTC:MBLTY) is an Australian
biotechnology company committed to the development of novel
treatments for orthopaedic conditions, including the rapid
commercialisation of a unique adult stem cell technology aimed at the
regeneration and repair of bone and cartilage. Our focus is to
progress through clinical trials and international regulatory
processes necessary to commercialise the technology in as short a
timeframe as possible.

Mesoblast has the worldwide exclusiv! e 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 Company has also
acquired a substantial 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 are jointly funding and progressing the core technology.
Mesoblast's strategy is to maximise shareholder value through both
corporate partnerships and the rapid and successful completion of
clinical milestones.

Mesoblast Limited
http://www.medicalnewstoday.com/articles/117350.php

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StemCells subscribers may also be interested in these sites:

Children's Neurobiological Solutions
http://www.CNSfoundation.org/

Cord Blood Registry
http://www.CordBlood.com/at.cgi?a=150123

The CNS Healing Group
http://groups.yahoo.com/group/CNS_Healing
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