Croatia, Austria, United Kingdom, Slovenia, Poland, Germany
Project funding
6.004.152,50 €
Project goals
Produce additional quantities of the final product for the needs of Phase II clinical study, conduct the Phase II clinical study to evaluate the safety and efficacy of a new formulation of OSTEOGROW (OSTEOproSPINE) for spinal fusion and relief of lumbar back pain in patients with degenerative disc disease compared with autologous bones and obtain the first clinical evidence of the effectiveness and safety of two doses of OSTEOproSPINE for PLIF compared with autologous bone grafting and develop the basis for a range of products that can form bone on the ectopic place.
Project results
The project is still ongoing, and all planned activities are proceeding according to schedule. The planned number of patients is recruited (n=143) and the follow-up phase is ongoing (ending in early 2023). The results show a high degree of safety while efficacy results are expected after completion of follow-up and unblinding.
Read more
Periodic Reporting for period 2 - OSTEOproSPINE (Novel Bone Regeneration Drug OSTEOGROW: Therapeutic Solution for Lumbar Back Pain) https://cordis.europa.eu/project/id/779340