Using vertebral bone marrow clot in spinal surgery
The Vertebral Bone Marrow Clot as Autologous Cell-therapy and Multifunctional Bio-scaffold Targeting the Key Challenges for Spinal Fusion Surgery
NA · Istituto Ortopedico Rizzoli · NCT05947175
This study is testing whether using a special type of bone marrow clot along with standard bone grafts can help people with degenerative spine diseases recover better after spinal surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bologna, BO) |
| Trial ID | NCT05947175 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy of autologous vertebral bone marrow aspirate (vBMA) clot combined with bone allograft chips in spinal fusion procedures for patients with degenerative spine diseases. It is a randomized controlled trial comparing this new treatment approach against the standard treatment of bone allograft chips alone. The study will also assess how age and gender may influence clinical outcomes, while exploring the regenerative, anti-inflammatory, and antibacterial properties of the vBMA clot. The goal is to establish a standardized procedure for using vBMA clot in spinal surgeries.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with degenerative spinal disorders requiring posterior spinal stabilization of up to 5 levels.
Not a fit: Patients with HIV, HBV, HCV, coagulation disorders, cancer, infections, or those who have had previous spinal surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance recovery and outcomes for patients undergoing spinal fusion surgery.
How similar studies have performed: While the use of vBMA in spinal surgery has been explored, the specific formulation of vBMA clot is a novel approach that has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Bologna, BO
- Istituto Ortopedico Rizzoli — Bologna, BO, Italy (RECRUITING)
Study contacts
- Study coordinator: Francesca Salamanna, PhD
- Email: francesca.salamanna@ior.it
- Phone: +390516366004
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Degenerative Spine Diseases, Spine, Spinal fusion, Degenerative diseases, Vertebral bone marrow, Clot