Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT)
- Conditions
- Degenerative Disc Disease
- Interventions
- Other: Use of patient-derived biological samples
- Registration Number
- NCT06490887
- Lead Sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Brief 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Pregnant female subjects Use of patient-derived biological samples Collection of amnion of human term placenta (38-40 weeks of gestation) within 6 hours of birth. Degenerative Disc Disease patients undergoing spine surgery Use of patient-derived biological samples Collection of blood. Collection of nucleous pulposus, annulus fibrosus and cartilaginous endplate biopsies that would be considered as waste material after surgery. Subjects undergoing plastic surgery Use of patient-derived biological samples Collection of adipose tissue that would be considered as waste material after surgery.
- Primary Outcome Measures
Name Time Method Efficacy of MSC-derived secretome 30 months Changes in gene expression in response to the treatment of the spine unit model with MSC-derived secretome. If the MSC-derived secretome is effective, genes upregulated or downregulated by inflammatory stimulation are expected to go back to their basal levels when the inflamed model is treated with MSC-derived secretome.
- Secondary Outcome Measures
Name Time Method Characterization of patient-specific degenerative features 30 months Identification of circulating degenerative features related to ageing and inflammation in patients affected by Degenerative Disc Disease (DDD) correlating with tissue degeneration.
Development of an organotypic spine unit model 30 months Determination of success or failure in the development of spine unit models for each enrolled patient from which cell isolation has been successful.
Trial Locations
- Locations (2)
IStituto MEditerraneo per i Trapianti e Terapie ad alta specializzazione
🇮🇹Palermo, Italy
IRCCS Ospedale Galeazzi-Sant'Ambrogio
🇮🇹Milan, MI, Italy