The Vertebral Bone Marrow Clot as Autologous Cell-therapy and Multifunctional Bio-scaffold Targeting the Key Challenges for Spinal Fusion Surgery

MORE_FOR_SPINE

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.

2023-05-19

2024-12-31

2026-05-18

Recruiting

96

Inclusion Criteria: * degenerative spinal disorders (based radiological diagnosis) * posterior spinal stabilization ≤ 5 levels * age between 18-80 years at the time of surgery Exclusion Criteria: * HIV * HBV * HCV * coagulations disorders * pregnant or breast-feeding women * cancer * infections * previous spinal surgery * radio- chemotherapy * myeloproliferative disease * chronic steroid medication, thyroxin, immunodepression

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2023-07-17