Mesoblast announced today positive results for its Neofuse Phase 2 clinical trial. Neofuse is a stem cell therapy containing mesenchymal precursors cells (MPC), the immediate derivatives of mesenchymal stem cells. The trial showed that the product is both efficient and safe to use, and will soon undergo the final testing before being released for commercial use. A total of 24 patients participated in the trial.
Neofuse is a product for replacing degenerated or missing discs. It contains mesenchymal precursors cells which develop into bone tissue and fuse naturally with the rest of the vertebrae. According to the manufacturing company, the operation is less invasive than the currently available treatments that only rely on removing bone from the hip and grafting it to the patient's spine.
During the second phase, the product proved to be both effective and safe. Some key findings of the trial are the following:Mesoblast's next goal is to start the third phase of the trial. The trial will be conducted in U.S., Europe and Australia. According to officials the third phase is expected to start sometime during 2013.
- Mesenchymal precursors cells were well tolerated with no serious adverse effects arising during the treatment.
- After one year, 85.7 % fusion was achieved compared to the 75 % of the patients that didn't receive Neofuse.
- Low back pain was reduced in all patients receiving the Neofuse product. Pain levels were comparable to the ones who didn't.
- Patients that received Neofuse had 30-43 % less blood loss than those who didn't
- Neofuse doesn't require an autograft bone harvest, thus avoiding the risks of the harvest-surgery, like infection, blood loss and wound pain on the operated area.
Let's hope everything goes well and their product soon gets FDA approval for commercial use.
Interview of Silviu Itesu, Mesoblast's CEO
- Mesoblast is an Australian biocompany that uses adult stem cells for bone and cartilage regeneration.