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

NCT07250126 | Recruiting

• 2 other identifiers: CDP-SUBTGR20250006
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Degenrative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Discovery of Tissue-Specific Molecular Markers in Intervertebral Disc Cellular Populations

  To identify genes that are specifically upregulated in one of the three intervertebral disc cellular populations-nucleus pulposus (NP), annulus fibrosus (AF), and cartilaginous endplate (CEP)-through comparative gene expression analysis of paired samples obtained from the same donors. This aim seeks to determine tissue-specific molecular markers that will be subsequently applied to the characterization of bioprinted intervertebral disc models.

  From enrollment to data analysis (24 months)

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient affected by Degenerative Disc disease undergoing spinal surgery

You may qualify if:

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

You may not qualify if:

• Presence of HIV, HBC, HCV or TPHA infection

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, MI, 20157, Italy

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: November 4, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: November 26, 2025

Record last verified: 2025-11

Locations

IT (1)