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NCT Number: NCT06490887

Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT)

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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Key information

Conditions

Degenerative Disc Disease Bone Diseases Inflammation Intervertebral Disc Degeneration Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Spinal Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Ospedale Galeazzi-Sant'Ambrogio, Milan, MI, Italy

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of patient-derived biological samples

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.

Primary outcomes

  1. Efficacy of MSC-derived secretome

    Time frame: 30 months

    Changes in gene expression in response to the treatment of the spine unit model with MSC-derived secretome. If the MSC-derived secretome is effective, genes upregulated or downregulated by inflammatory stimulation are expected to go back to their basal levels when the inflamed model is treated with MSC-derived secretome.

Secondary outcomes

  1. Characterization of patient-specific degenerative features

    Time frame: 30 months

    Identification of circulating degenerative features related to ageing and inflammation in patients affected by Degenerative Disc Disease (DDD) correlating with tissue degeneration.

  2. Development of an organotypic spine unit model

    Time frame: 30 months

    Determination of success or failure in the development of spine unit models for each enrolled patient from which cell isolation has been successful.

Sponsors and collaborators

Lead sponsor

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Other

Registry information

Official study title

Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT): Targeting Degeneration With Cell Secretome

Acronym: SUIT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 8, 2024
Registry last updated
Jul 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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