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

NCT ID: NCT07250126

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 5 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-04
• Study Completion Date: 2027-10-31

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, MI, Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Stefania Fichera

Role: primary

Stefania.Fichera@grupposandonato.it

+ 39 0283502229

Other Identifiers

GR20250006

Identifier Type: OTHER

Identifier Source: secondary_id

CDP-SUBT

Identifier Type: -

Identifier Source: org_study_id