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NCT05947175
Vertebral Bone Marrow Clot for Spinal Surgery
NA trial testing Vertebral bone marrow (vBMA) clot in Degenerative Spine Diseases in 96 participants. Currently enrolling.
31 December 2025
Quick facts
| Lead sponsor | Istituto Ortopedico Rizzoli |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 96 |
| Start date | 19 May 2023 |
| Primary completion | 31 December 2025 |
| Estimated completion | 18 May 2026 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Vertebral bone marrow (vBMA) clot — full drug profile →
- Bone allograft chips
Conditions studied
- Degenerative Spine Diseases — all drugs for Degenerative Spine Diseases →
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):
-
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
Verify or expand the search:
- PubMed search for NCT05947175
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05947175 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Ortopedico Rizzoli
- Last refreshed: 26 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05947175.
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