Vertebral Bone Marrow Clot for Spinal Surgery

The Vertebral Bone Marrow Clot as Autologous Cell-therapy and Multifunctional Bio-scaffold Targeting the Key Challenges for Spinal Fusion Surgery

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Degenerative Spine Diseases
• Intervention / Treatment: Biological: Vertebral bone marrow (vBMA) clot; Other: Bone allograft chips

Detailed Description

To evaluate the efficacy of autologous vBMA clot in SF procedures in patients with degenerative spine diseases, a randomized controlled trial (RCT) will be carried out. The study will compare patients treated with autologous vBMA clot associated to bone allograft chips versus bone allograft chips alone (standard treatment), also evaluating whether patient age and gender are associated with differences in the clinical outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 96
• 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group - vertebral bone marrow (vBMA) clot; Bone allograft chips will be obtained from Istituto Ortopedico Rizzoli while 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 associated with bone allograft chips 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 associated to bone allograft chips will be applied on each side of the vertebra according to the number of segments to be fused.	Biological: Vertebral bone marrow (vBMA) clot; The clotted 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.
Active Comparator: Control - bone allograft chips; Bone allograft chips will be obtained from Istituto Ortopedico Rizzoli. In detail, conventional posterior approach for lumbar SF will be performed. After the positioning of pedicle screws, the decompression of the cauda and nerve roots will be achieved with a hemilaminectomy and foraminotomy. Bone allograft chips alone 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.	Other: Bone allograft chips; Bone allograft chips will be obtained from Musculoskeletal Tissue Bank at IRCCS Istituto Ortopedico Rizzoli.

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 1, 3, 6, 12 months of FU, 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 1, 3, 6, 12 months of FU, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).	1 month
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 1, 3, 6, 12 months of FU, 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 1, 3, 6, 12 months of FU, will be evaluated basing on Brantigan classification (which ranges from A to E, with E score indicating better SF rate).	6 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 1, 3, 6, 12 months of FU, 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
Re-operation rate	The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.	At baseline (day 0)
Re-operation rate	The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.	1 month
Re-operation rate	The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.	3 month
Re-operation rate	The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.	6 month
Re-operation rate	The radiological outcome is the reduction of re-operation rate due to pseudoarthrosis that will be estimate by Brantigan classification.	12 month
Visual Analogue Score	Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)	1 month
Visual Analogue Score	Visual Analogue Score (which ranges from 0 to 100 with higher scores indicating more severe pain)	6 months
Oswestry Disability Index	Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)	1 month
Oswestry Disability Index	Oswestry Disability Index (ODI) (which ranges from 0 to 100 with higher scores indicating more severe disability)	6 months
Short Form Health Survey 36	Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)	At baseline (day 0)
Short Form Health Survey 36	Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)	1 month
Short Form Health Survey 36	Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)	3 months
Short Form Health Survey 36	Short Form Health Survey 36 (SF-36) (set of generic and coherent quality-of-life measures based on patient self-reporting outcomes)	6 months
Short Form Health Survey 36	Short Form Health Survey 36 (SF-36) (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.
• Sartori M, Tedesco G, Spinnato P, Mazzotti A, Gasbarrini A, Faldini C, Miceli M, Giavaresi G, Salamanna F. The Vertebral Bone Marrow clot as cell therapy and multifunctional bioscaffold for spinal fusion surgery: protocol for a randomized clinical trial. Front Med (Lausanne). 2025 May 9;12:1591041. doi: 10.3389/fmed.2025.1591041. eCollection 2025.

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): May 18, 2027

Study Registration Dates

• First Submitted: June 27, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 17, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 25, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Spine; Degenerative diseases; Spinal fusion; Clot; Vertebral bone marrow
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Clotrimazole
• Other Study ID Numbers: MORE_FOR_SPINE

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