P2 Trial for Cervical Spinal Fusion, Mesoblast, (ASX: MSB; ADR: MBLTY),
Australia’s MSB received clearance from the US’s FDA to begin Phase 2 clinical trials of its “off-the-shelf” or allogeneic stem cell product NeoFuse™ for fusion of the cervical spine in the neck.
MSB’s Phase 2 cervical fusion clinical program will compare two doses of NeoFuse™ versus standard-of-care in 36 patients requiring bony fusion at 2 or more levels in the cervical spine. The FDA-cleared trial will recruit 24 patients at multiple sites in the US, and 12 patients will be recruited at multiple sites in Australia. The trial objectives are to show the safety of the cells in this application, and whether fusion can occur faster and earlier than with standard-of-care over a 6 and 12 month period. Mesoblast’s preclinical trial results have shown that the MSB’s allogeneic cells generated earlier and more robust bony fusion of the cervical spine over a three-month period than either a recipient’s own bone (autograft) or synthetic material, with no cell-related adverse events.
As many as 200,000 fusions of the cervical spine are performed each year in the US alone, the majority for irreversible, end-stage degenerative disc disease
Mesoblast Limited (ASX: MSB; ADR: MBLTY) is a world leader in commercializing biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights for a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs).
