Chronic lumbar back pain, caused most often by degenerative spine disorders (DSD), affects millions of people worldwide and impairs the patient’s physical, psychological and social functioning. The prevalence of lumbar back pain requiring surgical intervention in EU represents a high burden for health care insurance agencies ranging in millions of Euros. Due to its high incidence (lumbar back pain is the second most common medical condition after common cold) and chronic nature, lumbar back pain is a frequent cause of absenteeism and thus has a direct impact on the economy. After therapeutic options to control the pain are exhausted, the patients need to undergo a spinal fusion, a surgical procedure that corrects spinal instability and alleviates lumbar back pain with associated leg pain. Unfortunately, the success rate of spinal fusion surgery is modest (approximately 35%). Novel therapies to extend the available treatment options are urgently needed.
The research performed within the project is based on a therapeutic system developed in the course of the FP7 project OSTEOGROW in which an autologous carrier and a biologically active protein (recombinant human bone morphogenetic protein 6 [rhBMP6]) are combined into an implant which accelerates and enhances bone repair. In OSTEOproSPINE, the implant is reinforced with a compression-resistant matrix to guide the formation of new bone at the extraskeletal site and replace bone harvested from the patient’s iliac crest for the fusion of lumbar vertebrae. By generating new bone, OSTEOproSPINE will restore the spine’s weight-bearing function, reduce the severity of back pain and improve the success rate of posterolateral spinal fusion surgery. The overall goal of OSTEOproSPINE is to provide a long-term solution for the treatment of degenerative spine disorder through a personalised bone implant.
To allow better treatment of degenerative spine disorder, OSTEOproSPINE pursues the following specific objectives:
• to evaluate the safety and efficacy of the OSTEOproSPINE regenerative treatment for spinal fusion and relief of lumbar back pain in a phase II clinical trial;
• to achieve long-lasting pain relief for patients with degenerative disc diseases;
• to evaluate whether the new bone regeneration drug Osteogrow together with allograft bone as a compression-resistant matrix (OSTEOproSPINE) can replace autologous iliac crest bone graft in patients undergoing PLIF and omit a second surgical procedure for harvesting pelvic bone;
• to obtain first clinical evidence of efficacy and safety of two OSTEOGROW doses for PLIF, in comparison with autologous bone grafting;
• to develop the basis for a series of products able to form extra-skeletal bone by tissue engineering.
During the 66 months of project implementation all the set-up objectives have been achieved. The clinical trial was successfully conducted and finalized for the included patients, despite difficult pandemic conditions. The clinical results indicate efficacy and safety of the therapy compared to the standard of care suggesting that an alternative treatment to autologous bone grafting is now available. The OSTEOGROW family of products have been developed and are being tested in additional indications, expanding the clinical use of this new regenerative therapy.
