TGA stem cell approval
July 22, 2010
THE Therapeutic Goods
Administration has approved a
license for Aussie company,
Mesoblast Ltd, to manufacture
adult stem cell products.
The license allows Mesoblast to
manufacture (in conjunction with
TGA licensed contractor Cell
Therapeutics) its proprietary
Mesenchymal Precursor Cell (MPC)
products, and supply them to both
hospitals and doctors for the repair
and regeneration of patient tissues.
Slated to take on the bone repair
market, the company’s initial output
will include products for long bone,
stress and vertebral fractures.
“Gaining a license from the TGA,
one of the world’s foremost regulatory
bodies, to manufacture our adult
stem cell products for supply to
Australian patients is a major
validating step in Mesoblast’s history,”
said Mesoblast ce, Silviu Itescu.
“It underscores the robustness of
our manufacturing process and the
excellent safety profile of our
products in patients.
“To our knowledge, this is the
first culture-expanded adult stem
cell product that has received
manufacturing approval anywhere
in the world,” he added.
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