Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06490887
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-03-28
Brief Title:
Spine Unit Modelling Coupled With hIgh Throughput Analysis SUIT
Sponsor:
IRCCS Ospedale Galeazzi-SantAmbrogio
Organization:
IRCCS Ospedale Galeazzi-SantAmbrogio
Study Overview
Official Title:
Spine Unit Modelling Coupled With hIgh Throughput Analysis SUIT Targeting Degeneration With Cell Secretome
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SUIT
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None