Millions of people worldwide suffer from chronic lumbar back pain, which is the second most common medical condition after a cold. Because of its chronic nature, lumbar back pain constitutes an enormous burden for patients and leads to very high costs for healthcare systems. Mostly caused by degenerative spine disorders, approximately 1.5 million patients in the EU alone need a surgical intervention to treat lumbar back pain.
This surgery has the aim to stabilise the lumbar back and is called posterolateral interbody spinal fusion (PLIF). In order to reduce back and associated leg pain, PLIF corrects spinal instability and typically accompanies spinal decompressions by using metal instrumentation and iliac crest bone from patients. As the iliac crest bone has to be harvested from the patients the current PLIF intervention implies risky intervention for the patient.
Therefore, new treatment options are urgently needed to improve the therapy for millions of patients suffering from lumbar back pain caused by degenerative spine disorder.
The overall vision of OSTEOproSPINE (“Novel Bone Regeneration Drug Osteogrow: Therapeutic Solution for Lumbar Back Pain“) was to provide a long-term solution for the treatment of degenerative spine disorders through a personalised bone implant. For this mission to succeed, 12 partners from six countries joined forces under the lead of the School of Medicine at the University of Zagreb.
As current surgical procedure of PLIF has a long-term success rate of about 35% and harvesting iliac crest bone implies additional risks, OSTEOproSPINE aimed to prove the safety and efficacy of an alternative in-patient treatment in a clinical trial.
The idea to improve therapeutic options for patients suffering from degenerative disc diseases by translating the patient’s peripheral blood into extra-skeletal bone has been further developed and tested in a Phase II clinical trial in the past 5,5 years. This treatment promises a constant stabilisation of the lumbar vertebrae to reduce pain and will prevent the need for an additional surgical procedure to harvest iliac crest bone.
The research is based on a therapeutic system developed in the course of the former FP7 - Health project OSTEOGROW in which an autologous carrier and a biologically active human protein were combined to accelerate and enhance bone repair. In OSTEOproSPINE, this novel drug OSTEOGROW was reinforced with a compression resistant matrix to guide the formation of new bone tissue.
The main activity within the OSTEOproSPINE program has been to test the new bone regeneration drug in patients undergoing PLIF in a clinical trial. Three clinical centres with the leading clinic site in AKH, Vienna carried out the study to assess the efficacy and safety of the approach. After a successful implementation of the trial, OSTEOproSPINE is now being developed further to become a “game changer” in the field of spinal surgery.
OSTEOproSPINE has been funded by the European Commission’s Research and Innovation Programme Horizon 2020 with a total budget of €6 million.
To allow a better treatment of degenerative spine disorder, the five-year project OSTEOproSPINE pursued the following strategic goals:
With a successful implementation of the OSTEOproSPINE clinical trial, next steps are taken to gain a marketing authorisation. This would help to re-establish the spine stability and eliminate pain associated with degenerative disc disorders for millions of patients in Europe and worldwide.
The project’s results could lead to eliminate any dependence of PLIF surgery on human tissue sources apart from the patient’s own blood.
By working closely together on an international level, OSTEOproSPINE has set new pathways for the innovation in spinal surgery for the benefit of patients and pressured healthcare systems in the EU.