NCT06490887

Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT)

Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT): Targeting Degeneration With Cell Secretome

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

Ageing and inflammation represent two main drivers of DDD, a progressive, chronic condition involving vertebral bone, cartilaginous endplate and intervertebral disc. In vitro investigation of the DDD-associated processes on single compartments of the spine unit or ex vivo animal models fail in recapitulating the complex spine pathophysiology or suffer from inter-species differences. Given these premises, a human organotypic model of the spine unit would represent a suitable tool to investigate the DDD-related pathways and to screen promising treatments such as MSC-based therapies.

Detailed description

The primary aim of this study is to investigate the response of an inflamed organotypic spine unit model, intended as a 3D in vitro representation of an in vivo environment, to the treatment with mesenchymal stem cells (MSC)-derived secretome. In particular to investigate the ability of MSC-derived secretome to modulate genes found to be upregulated or downregulated by the inflammatory stimulation in the spine unit model and bring their expression back to a basal state. Secondary aims of the study are: * To identify specific degenerative features related to ageing and inflammation in patients affected by Degenerative Disc Disease (DDD) correlating circulating features and tissue degeneration * To develop an organotypic spine unit model using patient-derived cells to investigate the response of cells derived from nucleus pulposus (NP), annulus fibrosus (AF) and cartilaginous endplate (CEP) to inflammation

Conditions

• Degenerative Disc Disease

Interventions

Type	Name	Description
OTHER	Use of patient-derived biological samples	We will use biological samples that are routinely collected as waste material from patients undergoing surgery or from pregnant women giving birth. Peripheral blood will be also collected from patients to conduct virological screening and isolate peripheral blood mononuclear cells.

Timeline

• Start date: 2023-06-28
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2024-07-08
• Last updated: 2024-07-08

Locations

2 sites across 1 country: Italy