NCT05947175

Vertebral Bone Marrow Clot for Spinal Surgery

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Istituto Ortopedico Rizzoli · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

To evaluate the efficacy of autologous vBMA clot in SF procedures in patients with degenerative spine diseases, a randomized controlled trial (RCT) will be carried out. The study will compare patients treated with autologous vBMA clot associated to bone allograft chips versus bone allograft chips alone (standard treatment), also evaluating whether patient age and gender are associated with differences in the clinical outcomes.

Conditions

• Degenerative Spine Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Vertebral bone marrow (vBMA) clot	The clotted vBMA will be obtained from vertebral bone marrow aspirate.The vBMA clot contain mesenchymal stem cells (MSCs), growth factors, platelet and osteogenic and anti-inflammatory mediators.
OTHER	Bone allograft chips	Bone allograft chips will be obtained from Musculoskeletal Tissue Bank at IRCCS Istituto Ortopedico Rizzoli.

Timeline

• Start date: 2023-05-19
• Primary completion: 2025-12-31
• Completion: 2026-05-18
• First posted: 2023-07-17
• Last updated: 2025-03-26

Locations

1 site across 1 country: Italy