Bone Marrow Clot for Posterior Lumbar Fusion

Efficacy of Autologous Bone Marrow Clot as Scaffold for Instrumental Posterior Lumbar Fusion

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.

Study Overview

• Status: Completed
• Conditions: Spinal Fusion
• Intervention / Treatment: Biological: Vertebral bone marrow clot

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • BO
    • Bologna, BO, Italy, 40136
      • Istituto Ortopedico Rizzoli

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Score	Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)	At baseline (day 0)
Visual Analogue Score	Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)	3 months
Visual Analogue Score	Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)	12 months
Oswestry Disability Index	Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)	At baseline (day 0)
Oswestry Disability Index	Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)	3 months
Oswestry Disability Index	Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)	12 months
EuroQoL-5L (EQ-5L)	EuroQoL-5L (EQ-5L) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)	At baseline (day 0)
EuroQoL-5L	EuroQoL-5L (EQ-5L) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)	3 months
EuroQoL-5L	EuroQoL-5L (EQ-5L) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)	12 months

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2020
• Primary Completion (Actual): July 19, 2022
• Study Completion (Actual): June 27, 2023

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: June 27, 2023
• First Posted (Actual): July 7, 2023

Study Record Updates

• Last Update Posted (Actual): October 11, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Spine; Degenerative diseases; Spinal fusion; Clot; Vertebral bone marrow
• Other Study ID Numbers: CVOD.clot

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No