Imagine a bone break that refuses to knit back together, leaving a person disabled for years. Instead of taking bone from another part of the patient's own body, this project creates a 'universal' kit of donor cells and materials. It's like having a standardized repair part ready to go as soon as a doctor sees a fracture isn't healing, rather than waiting until it's a total failure.
Long bone fractures that fail to heal cause years of disability and require expensive, repeated surgeries. Current autologous treatments are complex and often used too late in the healing process.
A master cell bank for allogenic production and a combined ATMP (cell therapy + biomaterial) supported by preclinical and clinical data.
If you are a cell therapy producer dealing with the high cost of patient-specific autologous treatments — this project developed a master cell bank for allogenic production that allows for a universal therapy. This enables wide access to treatment for a broad number of patients.
If you are a biomaterial manufacturer dealing with low adoption of bone grafts — this project developed a combined ATMP that pairs cells with biomaterials. This provides the necessary preclinical and clinical data to support EU approval for such combined products.
If you are a hospital group dealing with the high social and economic costs of long-term patient disability — this project developed a therapy to be used at an earlier time point (6 months or before). This prevents progression to severe non-unions and reduces the need for repeated procedures.
Based on available project data, specific pricing or cost figures are not provided; however, the project aims to reduce the high personal, social, and economic costs associated with severe non-unions.
The project is establishing a master cell bank for wide allogenic production, using specific donor selection criteria based on bone formation potential to ensure a universal supply.
The project explicitly states that scientific and regulatory information will be available via open access for other EU medical device companies and cell therapy producers.
The project is gathering the necessary preclinical and clinical information required to support EU approval for a specific combined ATMP.
The project period runs from December 1, 2023, to November 30, 2028.
The consortium is highly diversified with 21 partners across 5 countries, showing a strong mix of academic (7 universities) and research (7 institutes) expertise. While the industry ratio is relatively low at 10% (2 industrial partners, 1 of which is an SME), the presence of the Servicio Madrileño de Salud as coordinator ensures a direct link to public health procurement and clinical application.
Contact the Servicio Madrileño de Salud regarding the master cell bank and clinical trial data.
Contact us to identify potential licensing opportunities for the allogenic cell bank protocols.
