- Salvat’s new BONECURE project is an innovative medical advancement based on pre-differentiated mesenchymal cells designed to treat patients with bone consolidation problems post-fracture (atrophic pseudoarthrosis).
- A Phase II clinical trial is being completed with promising results in terms of both efficacy and safety, in patients with long bone pseudoarthrosis.
- Salvat has conducted this project in collaboration with the biopharmaceutical company Histocell, a company specializing in regenerative medicine and cell therapies.
Salvat, an international laboratory that develops and manufactures products such as Cristalmina, Cetraxal, Tebarat, Levogastrol, Monolitum and Relive, is completing the Phase II clinical trial of a new treatment for non-consolidated long-bone fractures (pseudoarthrosis). The clinical trial was approved by the Spanish Agency for Medicines and Medical Devices (AEMPS). In the trial, patients are followed for one year after the product’s application to test its efficacy, by assessing fracture healing. This project has been carried out in collaboration with the biopharmaceutical company Histocell, which specializes in regenerative medicine and cell therapies. All the patients have now been enrolled and included in the follow-up phase which will be completed by the end of 2020.
Salvat’s new treatment is based on pre-differentiated mesenchymal cells that are implanted in a calcium phosphate biomaterial and applied directly into the lesion site. The development of this therapy has required an investment of 6 million euros.
Bonecure results are very positive
Salvat is currently completing the Phase II clinical trial and the results are very promising. The research is being 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 bone fractures. In fact, in many cases, the fractures must be re-intervened surgically on several occasions, and at the moment, there is no effective treatment in these medical circumstances. This presents a life altering limitation in the daily functionality of patients, as well as a very high health expenditure due to the cost of medical care. BONECURE is intended to achieve a better and faster bone consolidation and due to its mechanism of action, a more complete functional recovery.
After completing this phase II study, Salvat plans to begin phase III clinical trials in 2021. The goal is to reach an agreement with the Spanish and European Health Authorities for this trials, and additionally to assess the possibility of extending the research to other bone pathologies. This new treatment could be marketed in Spain and throughout the European Community by 2023 and thereafter internationally.
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 appropriately. 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 operations. In addition, many patients experience a great deal of pain and dysfunction.
Long bones are more susceptible to breaks and are the most difficult to heal and consolidate. For example, the fracture of the tibia is one of the most common bone fractures and also, one of the most likely to develop pseudoarthrosis.