NCT05947175 Vertebral Bone Marrow Clot for Spinal Surgery
| NCT ID | NCT05947175 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituto Ortopedico Rizzoli |
| Condition | Degenerative Spine Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2023-05-19 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2023-05-19 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05947175 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Degenerative Spine Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05947175 currently recruiting?
Yes, NCT05947175 is actively recruiting participants. Contact the research team at francesca.salamanna@ior.it for enrollment information.
Where is the NCT05947175 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT05947175 clinical trial?
NCT05947175 is sponsored by Istituto Ortopedico Rizzoli. The trial plans to enroll 96 participants.