OSTEOGROW – the success story continues
The main objective of the OSTEOGROW project was to develop a novel therapy for bone repair to address an unmet medical need in therapeutic area of bone regeneration. The novel and innovative investigational medicinal product (IMP) called OSTEOGROW is being used to accelerate and enhance bone repair following fracture.
The high prevalence of acute bone fractures in the EU, in particular in osteoporotic patients, often with delayed/impaired healing and well-known complications poses a significant socio-economic burden. Currently, with no adequate therapy for the treatment of complicated bone fractures and non-unions available, medical interventions and healing rely on expensive bone devices often with associated side-effects. Through the development of a more efficient, cost-effective osteogenic medical product, with minimal side effects OSTEOGROW has contributed to finding a solution to this major medical problem. The design and manufacture of an OSTEOGROW kit supported the application of the concept in a clinical setting. It demonstrated the improvement of bone repair by utilizing autologous blood coagulum and minimal quantities of rhBMP6 following application directly in the fracture site. The originality of the OSTEOGROW approach rests on the innovative formulation and carrier design. The new therapy works by using the patient’s own blood in order to create a clot when in the operating theatre. The implant is then injected with rhBMP6 and placed between the broken bones’ ends, thus stimulating the formation of a new bone where needed. The therapy also has the advantage of reducing inflammatory reactions, common after the application of currently-used bone devices. Within several months, the new bone is created, taking only millilitres of blood to create the needed autologous blood clot.
Another important achievement of OSTEOGROW has been the education of young scientists through not only advanced research opportunities and hands-on training, but also scientific meetings and international exposure fostering their own careers as well as institutional excellence and the long-term scientific progress in the EU.
OSTEOGROW has demonstrated that the concept of an inexpensive production of a new biological entity (rhBMP6) and a pre-clinical and clinical development of a novel biocompatible therapeutic option is feasible in a short time frame and can be successfully implemented through an EU funded project. As we believe that OSTEOGROW device is superior and safer than currently used biological bone regeneration procedures, it might become an affordable new therapeutic solution for the enhancement of bone healing and prevention of bone non-unions with a very promising market potential.
In fact, a successful continuation of OSTEOGROW has already been achieved with the new Horizon 2020 project OSTEOproSPINE (“Novel Bone Regeneration Drug Osteogrow: Therapeutic Solution for Lumbar Back Pain“, GA no. 779340). Here the results of the project are being tested towards new indications, providing patients with lower back pain and in need of spinal fusion surgery access to this novel therapeutic option. A positive outcome of the OSTEOproSPINE trial will pave the way for further clinical development of OSTEOGROW regeneration therapy as a bone autograft equivalent for spinal fusion.