Bone healing with MSCs
Mesoblast announces good results from early phase trial in bone
repair.
Staff Writers 13/02/2008 12:02:49
Source: Mesoblast
Melbourne biotech Mesoblast has announced results from a clinical
trial of mesenchymal stem cell transplants in 10 patients suffering
from non-healing, long bone fractures of the legs.
All 10 patients have now been followed up for at least six months
post implantation, with no adverse events related to the cells
occurring in any patient.
In a statement, Mesoblast said all patients have shown new bone
formation. Seven patients have achieved union of their long bone
defects within a median time period of 4.9 months, and three continue
to show progressive new bone formation.
In contrast, none of the 10 had shown any evidence of new bone
formation for 5-41 months prior to stem cell implantation.
All patients with successful long bone union have been able to fully
weight bear and resume daily activities. Mesoblast's technology
eliminated the need in these patients for a second operation to
harvest bone from the pelvis.
A key result in the study was the observation of a direct
relationship between increasing the dose of stem cells implanted and
shortening the time to heal the bony defect, indicating that the stem
cells worked in a similar way to a pharmaceutical drug.
In patients whose fractures united within four months of treatment,
the median dose of stem cells implanted was 14 per cent higher than
in those uniting later, and 33 per cent higher than those who have
not yet achieved union.
Mesoblast's founder, Professor Silviu Itescu, said he was delighted
with the six-month results.
"These results clearly show that our proprietary stem cell technology
is safe and effective for speeding up bone fracture repair," he said.
"The identification of a dose-response with shorter time to healing
will be central to our upcoming Investigational New Drug (IND)
submission to the United States Food and Drug Administration (US FDA)
to use our allogeneic, or off-the-shelf, stem cells in patients with
long bone fractures."
http://www.biotechn
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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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