TGA approves Mesoblast MPC products for Australia
Thursday, 22 July, 2010
Regenerative medicine specialists Mesoblast announced today that the Australian Therapeutic Goods Administration (TGA) has granted the company a license to manufacture and supply its Mesenchymal Precursor Cell (MPC) products in Australia.
Mesoblast will now sell MPC products to doctors and hospitals around Australia for patient’s own, or autologous use, in the repair and regeneration of damaged tissues. The products will initially target the markets for bone repair, including long bone fractures following trauma, vertebral factures due to osteoporosis and stress fractures resulting from sports injuries. The cells will be manufactured via an agreement between Mesoblast and Melbourne-based contractor Cell Therapies.
Mesoblast Chief Executive Professor Silviu Itescu said that MPC is the first culture expanded adult stem cell product to be approved for manufacture anywhere in the world.
"Gaining a licence 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," he said.
"It underscores the robustness of our manufacturing process and the excellent safety profile of our products in patients”.
Silviu added that the company expects to see the rapid adoption of MPC in Australia which would produce valuable new clinical outcome data to be used by the company as part of future product filings locally and abroad.
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