First Spinal Fusion Trial, Mesoblast (ASX: MSB; ADR: MBLTY)
Mesoblast’s (MSB) 1st trial has completed enrolment and been reviewed by the Data Safety and Monitoring Board evaluating its proprietary allogeneic, or “off-the-shelf”, stem cells for poster lateral lumbar spinal fusion at NY’s Hospital for Special Surgery.
The trial compared the safety and efficacy of MSB’s NeoFuse™ allogeneic stem cell product on one side with the standard-of-care, autograft bone on the other side in the same patient. The results showed that implantation of the cells was safe and associated with earlier generation of new bone formation and fusion which was robust as determined by CT scan.
- Patients continue to be followed and to date no cell-related adverse events have occurred,
- At 6 months of follow-up, 3/5 sites (60%) that received the lowest dose tested of NeoFuse™ demonstrating fusion, as determined by bone bridging between 2 vertebrae whereas only 1/7 sites (14%) which received autograft demonstrated fusion,
- The initial results are encouraging and supports preclinical data which showed allogeneic cells generate faster fusion in the lumbar and cervical spine than the autograft standard-of-care.
MSB was established in 2004 to develop therapies for patients with bone and joint diseases with a license for orthopedic applications of proprietary adult stem cell technology developed by scientists at South Australia’s Hanson Institute and Institute of Medical and Veterinary Science (IMVS).
