3D bioprinted human spinal unit made from disc cells with gene profiling
Official title: 3D Biomimetic Spine Unit Model Through the Integration of Bioprinting and Transcriptomics (CDP-SUBT)
Run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · NCT07250126 · Data updated 2026-11-12
This project will test whether a 3D bioprinted spinal unit made from patients' disc cells reproduces the gene-expression patterns seen in people having surgery for moderate-to-severe degenerative disc disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years to 70 Years |
| Sex | All |
| Enrollment | 5 (estimated) |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, MI) |
| Status | Recruiting |
| Started | November 4, 2025 |
| Main results expected | October 2027 |
| Study ends | October 2027 |
| Registry record updated | November 26, 2025 |
| Trial ID | NCT07250126 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 30–70 with Pfirrmann grade III–V disc degeneration who are scheduled for spinal surgery and can give informed consent, and who do not have the listed blood-borne infections.
✕Probably not a fit
People who are not undergoing surgery, are outside the 30–70 age range, have milder disc degeneration (Pfirrmann I–II), or have active HIV, HBC, HCV, or TPHA infection are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Researchers will collect primary human cells from the nucleus pulposus, annulus fibrosus, and cartilaginous endplate of patients undergoing spinal surgery and define their transcriptional (gene-expression) profiles. Using those data as a reference, they will create a biomimetic spinal unit by bioprinting human cells into a 3D construct that incorporates key disc components. Cells recovered from the bioprinted constructs will undergo the same transcriptomic analyses to compare identity, heterogeneity, and fidelity to native disc tissues. The work is observational and performed at a single clinical site in Milan, with adult surgical patients (age 30–70) and standard infection exclusions.
Why it matters
Potential benefit: If successful, this model could provide a more realistic human-based laboratory platform for testing therapies and understanding disc biology, potentially accelerating development of treatments and reducing reliance on animal models.
How similar studies have gone: Related work has produced disc-like tissues and applied transcriptomics to musculoskeletal models, but fully biomimetic human 3D spinal unit models combining bioprinting and comprehensive transcriptomics remain relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, Mi, Italy Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.