Clinical trial NCT05947175: Vertebral Bone Marrow Clot for Spinal Surgery
Official title: The Vertebral Bone Marrow Clot as Autologous Cell-therapy and Multifunctional Bio-scaffold Targeting the Key Challenges for Spinal Fusion Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Degenerative Spine Diseases
Keywords: Spine
Spinal fusion
Degenerative diseases
Vertebral bone marrow
Clot
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2023-07-17
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility 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

Primary outcomes:
measure: Brantigan classification
timeFrame: At baseline (day 0)
measure: Brantigan classification
timeFrame: 1 month
measure: Brantigan classification
timeFrame: 3 months
measure: Brantigan classification
timeFrame: 6 months
measure: Brantigan classification
timeFrame: 12 months
Secondary outcomes:
measure: Re-operation rate
timeFrame: At baseline (day 0)
measure: Re-operation rate
timeFrame: 1 month
measure: Re-operation rate
timeFrame: 3 month
measure: Re-operation rate
timeFrame: 6 month
measure: Re-operation rate
timeFrame: 12 month
measure: Visual Analogue Score
timeFrame: At baseline (day 0)
measure: Visual Analogue Score
timeFrame: 1 month
measure: Visual Analogue Score
timeFrame: 3 months
measure: Visual Analogue Score
timeFrame: 6 months
measure: Visual Analogue Score
timeFrame: 12 months
measure: Oswestry Disability Index
timeFrame: At baseline (day 0)
measure: Oswestry Disability Index
timeFrame: 1 month
measure: Oswestry Disability Index
timeFrame: 3 months
measure: Oswestry Disability Index
timeFrame: 6 months
measure: Oswestry Disability Index
timeFrame: 12 months
measure: Short Form Health Survey 36
timeFrame: At baseline (day 0)
measure: Short Form Health Survey 36
timeFrame: 1 month
measure: Short Form Health Survey 36
timeFrame: 3 months
measure: Short Form Health Survey 36
timeFrame: 6 months
measure: Short Form Health Survey 36
timeFrame: 12 months
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Istituto Ortopedico Rizzoli
state: BO
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.