- It is an innovative project based on pre-differentiated mesenchymal stem cells designed to treat patients with bone consolidation problems post-fracture (atrophic pseudoarthrosis).
- A Phase II clinical trial has been completed, with very promising results in terms of efficacy and safety, in patients with pseudoarthrosis of long bones.
- Salvat has invested more than 10 million Euros in this project in collaboration with the biopharmaceutical company Histocell, a company specialized in regenerative medicine and cell therapies.
Salvat, an international laboratory with its headquarters in Barcelona, Spain, has completed the Phase II clinical trial of a new treatment for non-consolidated long-bone fractures (pseudoarthrosis). The clinical trial design was agreed with the Spanish Agency for Medicines and Medical Devices (AEMPS). After the application of the product, patients were followed for two years to test its efficacy and safety, by assessing the fracture healing and the appearance of adverse events. This project has been carried out in collaboration with the biopharmaceutical company Histocell, which specializes in regenerative medicine and cell therapies.
Salvat’s new treatment is based on pre-differentiated allogeneic mesenchymal stem cells that are implanted in a calcium phosphate biomaterial and applied directly into the lesion site. Salvat has invested more than 10 million Euros in developing this innovative therapy.
Very positive results
Salvat has completed the Phase II clinical trial and the results are very promising. The research has been conducted at the Teknon Medical Center in Barcelona and the Hospital Universitario La Paz in Madrid. Patients affected by atrophic pseudoarthrosis have serious problems in consolidating their fracture. In fact, in many cases, the fractures must be re-intervened surgically on several occasions, and nowadays there is no effective treatment for these situations. This condition has a big impact on patients’ daily functionality, as well as a very high health expenditure due to the cost of medical care. BONECURE is intended to achieve a good and faster bone consolidation allowing for a more complete functional recovery.
Based on these good results, Salvat plans now to continue with the clinical development, which will be discussed with the European Medicines Agency (EMA) in a Scientific Advice Meeting. The possibility of extending the research to other bone pathologies will also be discussed.
Long bones are the most difficult to consolidate
The new treatment is indicated for pseudoarthrosis or broken bone that has not consolidated. Usually, a period of 9 months is required before a fracture is considered to have healed correctly. Although it is not a very frequent complication (4% of fractures), pseudoarthrosis requires a great deal of attention from traumatologists, and some cases require more than three surgeries, being also highly painful and dysfunctional.
Long bones are the ones that break most easily and cost the most to consolidate. The fracture of the tibia is one of the most common bone fractures and one of the most likely to develop pseudoarthrosis.