drugset / Trial / NCT05947175

Vertebral Bone Marrow Clot for Spinal Surgery

NCT05947175 ↗

Active not recruiting 96 enrolled Rizzoli Orthopaedic Institute
RandomizedParallel-groupSingle-blindTreatment

Summary

Spinal fusion (SF) is a common orthopedic procedure to treat spinal diseases. Apart from fixation systems, the procedure requires bone grafting to further improve SF. Cell-based therapies as vertebral bone marrow aspirate (vBMA) with bone allograft were developed as alternative to bone autograft in SF. However, vBMA use is limited by the lack of a standardized procedure, of a structural texture and by the possibility of diffusion away from the implant site. Recently, the potential use of a new formulation of vBMA, named vBMA clot, has been described. The project aims at evaluating the clinical evidence and the biological features of vBMA clot associated to bone allograft for SF surgery, considering age and gender related differences. A randomized controlled trial will prove the efficacy of the treatment and advanced preclinical studies will improve the knowledge on vBMA clot regenerative and anti-inflammatory properties, exploring for the first time its antibacterial characteristics.

Timeline

Start
2023-05-19
Primary completion
2026-12-31
Completion
2027-05-18

Drugs

EvaluationDrugModalityDoseRoute
Subject Vertebral bone marrow (vBMA) clot Cell therapy — —
Background Bone allograft chips Unknown — —