Australian adult stem cell company, Mesoblast Limited has commenced pre-clinical trials at Colorado State University in support of its Investigational New Drug (IND) submissions to the United States Food & Drug Administration (FDA).
Mesoblast is trialing its proprietary universal adult stem cells for treatment of long bone fractures and for spinal fusion. These trials are being performed in combination with FDA-approved carrier materials provided through an agreement with one of the world's largest medical devices companies and a leader in the international orthopaedic markets.
"In studies undertaken to date, we have found that our proprietary adult stem cells do not stimulate immune cells from an unrelated individual," Mesoblast Founder and Chief Scientific Adviser, Professor Silviu Itescu, said adding, “This forms the basis for Mesoblast's approach of obtaining adult stem cells from selected, or universal, donors, growing them up in commercially scaleable quantities, and using them to treat totally unrelated recipients, in much the same way as a drug.”
"We expect initial results from these trials to be available after three months, and to show a more effective product meeting the needs of the very large global bone regeneration markets," Professor Itescu said.
Mesoblast Limited is an Australian biotechnology company involved in 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.