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Recruiting NCT07250126

3D Biomimetic Spine Unit Model Through the Integration of Bioprinting and Transcriptomics (CDP-SUBT)

— Observational Degenrative Disc Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Degenrative Disc Disease. Basic parameters: 30 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The general objective of this project is to define the transcriptional profile of primary human cells derived from the nucleus pulposus (NP), annulus fibrosus (AF), and cartilaginous endplate (CEP), and to use this information as a reference to assess the biological relevance of a biomimetic spinal unit model obtained through bioprinting. By developing an in vitro model of human origin that incorporates key components of the spinal unit and applying transcriptional analyses to both native cells and their counterparts recovered from the 3D construct, the study will evaluate how accurately the bioprinted model reproduces the identity and heterogeneity of the native discal environment.

Primary outcome measures

  • Discovery of Tissue-Specific Molecular Markers in Intervertebral Disc Cellular Populations [Time frame: From enrollment to data analysis (24 months)]

Eligibility criteria

Inclusion criteria

  • Signature of the Informed Consent for the study
  • Age 30-70 years (included)
  • Pfirrmann grade III-V
  • Need to undergo spinal surgery

Exclusion criteria

  • Presence of HIV, HBC, HCV or TPHA infection

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Italy · 1 center
  • IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan

Identifiers

NCT: NCT07250126 · CDP-SUBT · GR20250006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗