3D bioprinted human spinal unit made from disc cells with gene profiling
3D Biomimetic Spine Unit Model Through the Integration of Bioprinting and Transcriptomics (CDP-SUBT)
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 |
|---|---|
| Enrollment | 5 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 1 site (Milan, MI) |
| Trial ID | NCT07250126 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Milan, MI
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Mi, Italy (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.