Ten patients with a total of 11 non-healing fractures of the long bones in the legs (following road trauma in 8) were operated on using Mesoblast's proprietary stem cells. After completing 12 months of follow-up, eight achieved complete bony union post stem cell implantation, and a ninth (with fractures of both the femur and tibia) achieved bony union of the tibia only, within a median time of 4 months. These same patients had a non-united fracture for up to 41 months prior to cell implantation, with a median of 10 months.
Of the 8 patients who had successful long bone union, all have been able to fully weight bear and resume daily activities. In these patients, Mesoblast's technology eliminated the need for a second operation to harvest bone from the pelvis. Equally as important, no adverse events related to the stem cell therapy occurred during this period. The remaining two patients had complex road trauma fractures involving multiple bones, which required re-operation.
Principal Investigator and orthopaedic surgeon, Mr Richard de Steiger, said the results were "exciting and underscore the extremely bright future for this cutting-edge technology.
"The positive outcomes in this trial pave the way for randomised, multi-centre clinical trials using Mesoblast's allogeneic or unrelated donor cells.
"Good results are likely to be seen with allogeneic cells as there should be reproducibility of outcomes and enhanced dosage predictability using a batched product derived from a young, healthy donor," Mr de Steiger said.
Mesoblast's Executive Director, Professor Silviu Itescu, said that Mesoblast's current focus is on Phase 2 Investigational New Drug (IND) submissions to the United States Food and Drug Administration (FDA) for the company's allogeneic stem cells in the treatment of non-union and high-risk fresh fractures.
"These results clearly show that our proprietary stem cell technology is safe and effective for speeding up bone fracture repair. There is a clear need for a minimally invasive, highly effective therapy to accelerate fracture repair and treat or prevent non-union, and we believe that Mesoblast's technology is ideally suited to deliver such a product," Professor Itescu said.
Tens of millions of people worldwide suffer from non-union long bone fractures, a debilitating condition mainly associated with victims of road accident trauma and which, in some cases, may result in limb amputation. Many more patients suffer from severe fractures that heal slowly or poorly and are at high risk for non-union. These conditions represent major costs to health authorities globally and major commercial opportunities for Mesoblast.
About The Royal Melbourne Hospital
The Royal Melbourne Hospital is one of Victoria's leading public teaching hospitals and adult trauma centre, providing acute tertiary referral services at its City Campus and aged care, rehabilitation, ambulatory care and residential and community services at its Royal Park Campus.
About Mesoblast Limited
Mesoblast Limited (ASX:MSB) (OTC ADR: MBLTY) is the world's leading developer of innovative biological products for the broad field of regenerative medicine.
Mesoblast's commercial strategy is based on its unique proprietary adult mesenchymal precursor cells.
The company's lead products will target cardiovascular conditions, diabetes, inflammatory conditions of lungs and joints, eye diseases, bone marrow cancers, bone fractures, cartilage degeneration and musculoskeletal conditions.
Mesoblast and global biopharmaceutical company Cephalon Inc. have established a strategic alliance to commercialize adult stem cell products for degenerative conditions of the cardiovascular and central nervous systems. The alliance also extends to products for augmenting bone marrow transplantation in cancer patients.