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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07250126
Acronym
CDP-SUBT
Enrollment
5
Registered
2025-11-26
Start date
2025-11-04
Completion date
2027-10-31
Last updated
2025-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenrative Disc Disease

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.

Interventions

None listed

Sponsors

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

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Discovery of Tissue-Specific Molecular Markers in Intervertebral Disc Cellular PopulationsFrom enrollment to data analysis (24 months)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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026