Bone Marrow Clot for Posterior Lumbar Fusion

NCT05936047 | Completed

• 1 other identifier: CVOD.clot
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Fusion

Keywords

Spine; Spinal fusion; Degenerative diseases; Vertebral bone marrow; Clot

Outcome Measures

Primary Outcomes (3)

• Brantigan classification

  Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at FUs, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).

  At baseline (day 0)

• Brantigan classification

  Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at FUs, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).

  3 months

• Brantigan classification

  Improvement of spinal fusion rate and time in patients treated with vBMA clot associated to bone allograft chips in comparison to bone allograft chips alone, also considering age and gender differences. CT-scan and X-ray, perform pre-operatively and at FUs, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).

  12 months

Secondary Outcomes (9)

• Visual Analogue Score

  At baseline (day 0)

• Visual Analogue Score

  3 months

• Visual Analogue Score

  12 months

• Oswestry Disability Index

  At baseline (day 0)

• Oswestry Disability Index

  3 months

Study Arms (1)

Experimental

EXPERIMENTAL

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.

Biological: Vertebral bone marrow clot

Interventions

Vertebral bone marrow clot BIOLOGICAL

vBMA will be harvested from each patient vertebral pedicle with the preparation of the site for pedicle screw insertion during spinal surgery. After the positioning of pedicle screws, the decompression of the cauda and nerve roots will be achieved with a hemilaminectomy and foraminotomy. vBMA clot will be opposed on the hemi-laminae and transvers process on the contralateral side of the hemilaminectomy. On the hemilaminectomy side, foramino-arthrectomy will be performed to insert the interbody fusion cage if necessary. After aspiration, the vBMA will be clotted and used for surgical procedure. vBMA clot will be applied on each side of the vertebra according to the number of segments to be fused.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istituto Ortopedico Rizzoli: lead

Study Sites (1)

Istituto Ortopedico Rizzoli

Bologna, BO, 40136, Italy

Location

Related Publications (3)

• Salamanna F, Contartese D, Giavaresi G, Sicuro L, Barbanti Brodano G, Gasbarrini A, Fini M. A Rationale for the Use of Clotted Vertebral Bone Marrow to Aid Tissue Regeneration Following Spinal Surgery. Sci Rep. 2020 Mar 5;10(1):4115. doi: 10.1038/s41598-020-60934-2.

  PMID: 32139727 BACKGROUND

• Salamanna F, Contartese D, Nicoli Aldini N, Barbanti Brodano G, Griffoni C, Gasbarrini A, Fini M. Bone marrow aspirate clot: A technical complication or a smart approach for musculoskeletal tissue regeneration? J Cell Physiol. 2018 Apr;233(4):2723-2732. doi: 10.1002/jcp.26065. Epub 2017 Jul 24.

  PMID: 28639702 BACKGROUND

• Salamanna F, Contartese D, Borsari V, Pagani S, Barbanti Brodano G, Griffoni C, Ricci A, Gasbarrini A, Fini M. Two Hits for Bone Regeneration in Aged Patients: Vertebral Bone Marrow Clot as a Biological Scaffold and Powerful Source of Mesenchymal Stem Cells. Front Bioeng Biotechnol. 2022 Jan 18;9:807679. doi: 10.3389/fbioe.2021.807679. eCollection 2021.

  PMID: 35118056 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 7, 2023
• Study Start: November 27, 2020
• Primary Completion: July 19, 2022
• Study Completion: June 27, 2023
• Last Updated: October 11, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)