Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT)

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

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-28

Study Completion Date

2025-08-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Degenerative Disc Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Degenerative Disc Disease patients undergoing spine surgery

Collection of blood. Collection of nucleous pulposus, annulus fibrosus and cartilaginous endplate biopsies that would be considered as waste material after surgery.

Use of patient-derived biological samples

Intervention Type OTHER

We will use biological samples that are routinely collected as waste material from patients undergoing surgery or from pregnant women giving birth. Peripheral blood will be also collected from patients to conduct virological screening and isolate peripheral blood mononuclear cells.

Subjects undergoing plastic surgery

Collection of adipose tissue that would be considered as waste material after surgery.

Use of patient-derived biological samples

Intervention Type OTHER

We will use biological samples that are routinely collected as waste material from patients undergoing surgery or from pregnant women giving birth. Peripheral blood will be also collected from patients to conduct virological screening and isolate peripheral blood mononuclear cells.

Pregnant female subjects

Collection of amnion of human term placenta (38-40 weeks of gestation) within 6 hours of birth.

Use of patient-derived biological samples

Intervention Type OTHER

We will use biological samples that are routinely collected as waste material from patients undergoing surgery or from pregnant women giving birth. Peripheral blood will be also collected from patients to conduct virological screening and isolate peripheral blood mononuclear cells.

Interventions

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Use of patient-derived biological samples

We will use biological samples that are routinely collected as waste material from patients undergoing surgery or from pregnant women giving birth. Peripheral blood will be also collected from patients to conduct virological screening and isolate peripheral blood mononuclear cells.

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes