Australia's adult stem cell company, Mesoblast Limited has entered into agreements with Colorado State University to perform preclinical dose-escalation trials of its proprietary, universal donor adult stem cell technology for the treatment of long bone fractures, and for a new indication, intervertebral spinal fusion.
The trials are set to commence prior to the end of August, with the first results expected to be available within five months of trial initiation.
Mesoblast's founder and chief scientific adviser, Professor Silviu Itescu, said the trials were important milestones in Mesoblast's plan to gain timely United States FDA Investigational New Drug (IND) approvals for use of its universal donor adult stem cells in patients needing bone repair/regeneration.
"A major advantage of Mesoblast's technology is that the proprietary adult stem cells are not rejected by the immune cells of an unrelated recipient," professor Itescu said.
"This opens the possibility to develop an 'off-the-shelf' universal donor adult stem cell product, significantly reducing cost-of-goods, enabling immediate product availability, and increasing the likelihood of widespread product uptake. Spinal fusion as a treatment for end-stage intervertebral disc disease represents a very large and established global market opportunity for Mesoblast," he added.
"Currently, almost 300,000 spinal fusion procedures are performed annually in the United States alone, most using a patient's own bone tissues. Mesoblast's universal adult stem cells could provide a more effective alternative for intervertebral bone regeneration without the associated pain and other complications of a bone graft," Professor Itescu said.