Setting new pathways for the innovation in spinal surgery for the benefits of patients and healthcare systems in the EU

Background

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.

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OSTEOproSPINE Vision

The overall vision of OSTEOproSPINE (“Novel Bone Regeneration Drug Osteogrow: Therapeutic Solution for Lumbar Back Pain“) is 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 have 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 aims to prove the safety and efficacy of an alternative in-patient treatment in a clinical trial.

The idea is to improve therapeutic options for patients suffering from degenerative disc diseases by translating the patient’s peripheral blood into extra-skeletal bone. 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 will be 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 is reinforced with a compression resistant matrix to guide the formation of new bone tissue.

The main activity within the OSTEOproSPINE program will be 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 will carry out the study to assess the efficacy and safety of the approach. If proven successful, OSTEOproSPINE will be a “game changer” in the field of spinal surgery.

OSTEOproSPINE is funded by the European Commission’s Research and Innovation Programme Horizon 2020 with a total budget of €6 million.

Main Objectives

To allow a better treatment of degenerative spine disorder, the five-year project OSTEOproSPINE pursues the following strategic goals:

Expected Results

If the clinical trial within the project is successful, a marketing authorisation of OSTEOproSPINE is envisaged in the long term. 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 sets new pathways for the innovation in spinal surgery for the benefit of patients and pressured healthcare systems in the EU.