Bone Marrow Clot for Posterior Lumbar Fusion

Istituto Ortopedico Rizzoli

Status: Completed

Conditions: Spinal Fusion

Treatments: Biological: Vertebral bone marrow clot

Study type: Interventional

Funder types: Other

Identifiers

NCT05936047

CVOD.clot

Details and patient eligibility

About

Bone marrow aspirate (BMA) in association to graft substitutes has long been introduced as a promising alternative to iliac crest bone graft in spinal fusion. However, BMA use is limited by the absence of a standardized technique, of a physical texture and by the possibility of dispersion away from the implant site. Recently, the potential use of a new formulation of BMA, named BMA clot, has been preclinically described. A prospective pilot clinical study designed to assessing the safety and efficacy of autologous vertebral BMA (vBMA) clot as multifunctional bio-scaffold in instrumental posterior lumbar fusion will be performed.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over the age of 18 at the time of surgery
• symptomatic degenerative spine disease needing posterior fusion at the lumbar tract

Exclusion criteria

• any form of local or systemic infections, inflammatory or autoimmune disease
• coagulation disorders
• tumor diseases
• alcohol or drug abuse
• pregnancy
• chemotherapeutic drugs that might interfere with bone regeneration processes
• revision surgery

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Experimental

Experimental group

Description:

The clotted vertebral bone marrow aspirate (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.

Treatment:

Biological: Vertebral bone marrow clot