RecruitingNot ApplicableNCT05947175

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


Sponsor

Istituto Ortopedico Rizzoli

Enrollment

96 participants

Start Date

May 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

  • degenerative spinal disorders (based radiological diagnosis)
  • posterior spinal stabilization ≤ 5 levels
  • age between 18-80 years at the time of surgery

Exclusion Criteria11

  • HIV
  • HBV
  • HCV
  • coagulations disorders
  • pregnant or breast-feeding women
  • cancer
  • infections
  • previous spinal surgery
  • radio- chemotherapy
  • myeloproliferative disease
  • chronic steroid medication, thyroxin, immunodepression

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Interventions

BIOLOGICALVertebral 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.

OTHERBone allograft chips

Bone allograft chips will be obtained from Musculoskeletal Tissue Bank at IRCCS Istituto Ortopedico Rizzoli.


Locations(1)

Istituto Ortopedico Rizzoli

Bologna, BO, Italy

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NCT05947175