Identification of Biomarkers and Molecular Targets Involved on Intervertebral Disc Degeneration and Discogenic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-22

Study Completion Date

2025-05-21

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Intervertebral Disc Degeneration Discogenic Pain Discogenic Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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cell isolation from intervertebral disc tissue and biomarker investigation

metabolomic, cellular and molecular analysis on intervertebral disc derived cells and investigation of tissue neuroinflammatory and pain-related biomarkers

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients with disc degeneration for spondylolisthesis, herniated intervertebral disc, and other causes of disc degeneration

Exclusion Criteria

* Spinal infection

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marco Locatelli, MD, PhD

Role: STUDY_DIRECTOR

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Neurosurgery Unit

Mauro Pluderi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Neurosurgery Unit

Giovanni Marfia, MD, PhD

Role: STUDY_CHAIR

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Neurosurgery Unit, Istituto di Medicina Aerospaziale di Milano, CeMATA - Aeronautica Militare