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NCT05947175

Vertebral Bone Marrow Clot for Spinal Surgery

Recruiting now NA Last updated 26 March 2025
What this trial tests

NA trial testing Vertebral bone marrow (vBMA) clot in Degenerative Spine Diseases in 96 participants. Currently enrolling.

Timeline
19 May 2023
Primary endpoint
31 December 2025
18 May 2026

Quick facts

Lead sponsorIstituto Ortopedico Rizzoli
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment96
Start date19 May 2023
Primary completion31 December 2025
Estimated completion18 May 2026
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

Istituto Ortopedico Rizzoli — full company profile →

Who can join

Adults 18 to 80, any sex, with Degenerative Spine Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The Vertebral Bone Marrow clot as cell therapy and multifunctional bioscaffold for spinal fusion surgery: protocol for a randomized clinical trial.
    Sartori M, Tedesco G, Spinnato P, Mazzotti A, et al · · 2025 · PMID 40417680 · DOI 10.3389/fmed.2025.1591041

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