Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349226
Status:
RECRUITING
Last Update Posted:
2024-04-05
First Post:
2024-03-21
Brief Title:
Identification of Biomarkers and Molecular Targets Involved on Intervertebral Disc Degeneration and Discogenic Pain
Sponsor:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Organization:
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Study Overview
Official Title:
Development of New Diagnostic Prognostic and Therapeutic Strategies in the Field of Degenerative Disc Disease Identification of Biomarkers and Molecular Targets Involved in Discogenic Pain and Neuroinflammation
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
Low back pain associated with intrinsic disorders of the spine is a very frequent clinical condition that is accompanied by high morbidity with effects both on psychosocial aspects and health care system It occurs in approximately 80 of the population throughout their lives Most low back pain is associated with intervertebral disc degeneration IDD associated with neuroinflammation and pain In this context the study of sphingolipid metabolism can play an important role in the identification of new molecules responsible for the degenerative process Sphingolipids in fact are a class of molecules that are implicated in multiple signal pathways such as proliferation degradation of the extracellular matrix inflammatory state apoptosis and migration In particular sphingosine-1-phosphate S1P an intermediate of sphingolipid metabolism acts as a pro-inflammatory mediator predominantly in the extracellular environment regulating important cellular properties related to inflammatory potential and pain The objective of this study is to characterize the degenerative process in cells isolated from degenerated human intervertebral discs from both at cellular and molecular levels in order to identify new targets implicated in degenerative processes including sphingolipid signaling pathway
Detailed Description:
Low back pain LBP is a serious public health problem and has been identified as the most widespread cause of disability worldwide by the 2013 Global Burden of Disease Study It is estimated that in the Western world the annual incidence of acute low back pain is 5 in adults and that the lifetime prevalence is 80 Although different anatomical structures can be implicated in the generation of LBP in many cases this is associated with the degeneration of the intervertebral disc IVD IVD degeneration IDD represents a chronic age-related process characterized by a progressive reduction in the content of proteoglycans and water in the nucleus pulposus NP with the subsequent loss of the ability of the disc to respond to compressive forces with the possible appearance of instability Furthermore this degenerative process is accompanied by the development of a highly inflammatory microenvironment which contributes to exacerbating the degenerative process leading to the progressive structural failure of the disc itself and in most cases to pain From these premises arises the need to better investigate all the cell-mediated mechanisms underlying IDD to identify and develop new therapies aimed at recovering the IVD and reducing pain
In this context sphingolipids a class of molecules responsible for multiple signal pathways such as proliferation migration apoptosis and angiogenesis appear to play a key role in exacerbating the inflammatory process and degradation of the extracellular matrix in conditions of IDD Sphingosine-1-phosphate S1P is an intermediate of sphingolipid metabolism formed from sphingosine through the action of sphingosine kinases SphK1 SphK2 Increasing evidence suggests that S1P acts as a pro-inflammatory signal predominantly in the extracellular environment regulating important cellular properties correlated with the inflammatory potential on chondrocyte-like cells It has been reported that an alteration in the production and secretion of these molecules is capable of increasing the inflammatory and degenerative condition in various pathologies related to neuroinflammation and pain The aim of the project is to define new disease biomarkers and characterize the degenerative process in cells isolated from degenerated human intervertebral discs from both at cellular and molecular levels in order to identify new targets implicated in degenerative processes including sphingolipid signaling pathway Secondary objective is the analysis of the effectiveness of the modulation of sphingolipid metabolism and the in vitro testing of molecules with therapeutic potential
A greater understanding of the events implicated in the pathogenesis of IDD both at macroscopic and microscopic levels is of fundamental importance for the development of new diagnostic tools to be combined with current therapeutic strategies
In this context sphingolipids a class of molecules responsible for multiple signal pathways such as proliferation migration apoptosis and angiogenesis appear to play a key role in exacerbating the inflammatory process and degradation of the extracellular matrix in conditions of IDD Sphingosine-1-phosphate S1P is an intermediate of sphingolipid metabolism formed from sphingosine through the action of sphingosine kinases SphK1 SphK2 Increasing evidence suggests that S1P acts as a pro-inflammatory signal predominantly in the extracellular environment regulating important cellular properties correlated with the inflammatory potential on chondrocyte-like cells It has been reported that an alteration in the production and secretion of these molecules is capable of increasing the inflammatory and degenerative condition in various pathologies related to neuroinflammation and pain The aim of the project is to define new disease biomarkers and characterize the degenerative process in cells isolated from degenerated human intervertebral discs from both at cellular and molecular levels in order to identify new targets implicated in degenerative processes including sphingolipid signaling pathway Secondary objective is the analysis of the effectiveness of the modulation of sphingolipid metabolism and the in vitro testing of molecules with therapeutic potential
A greater understanding of the events implicated in the pathogenesis of IDD both at macroscopic and microscopic levels is of fundamental importance for the development of new diagnostic tools to be combined with current therapeutic strategies
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