Clinical trial NCT06490887: Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT)
Official title: Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT): Targeting Degeneration With Cell Secretome
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Disc Disease
Keywords: inflammation
degeneration
spine unit
intervertebral disc
mesenchymal stem cell
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2024-07-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples will be collected from Degenerative Disc Disease patients undergoing spine surgery, from patients subjected to surgeries that involve the removal of adipose tissue and from pregnant women within 6 hours from giving birth.

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

Eligibility criteria: DDD patients:

* Signature of the Informed Consent for the study
* Age 30-60 years (included)
* Pfirrmann grade III-V
* Need to undergo spinal surgery

Subjects for the isolation of adipose-derived MSCs:

* Signature of the Informed Consent for the study
* Age 18-50 (included)
* Need to undergo surgery that involves the removal of adipose tissue

Subjects for the isolation of placenta-derived MSCs:

* Signature of the Informed Consent for the study
* Age 18-50 (included)
* Women who are pregnant or who have not given birth from more than 6 hours

All enrolled subjects:

- Presence of HIV, HBV, HCV or TP infection

Primary outcomes:
measure: Efficacy of MSC-derived secretome
timeFrame: 30 months
Secondary outcomes:
measure: Characterization of patient-specific degenerative features
timeFrame: 30 months
measure: Development of an organotypic spine unit model
timeFrame: 30 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio
state: MI
city: Palermo
country: Italy
facility: IStituto MEditerraneo per i Trapianti e Terapie ad alta specializzazione
Study officials:
References: