Degenrative Disc DiseaseCDP-SUBTNCT07250126
3D Biomimetic Spine Unit Model Through the Integration of Bioprinting and Transcriptomics (CDP-SUBT)
An observational study of Degenrative Disc Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Degenrative Disc Disease
- How many people
- 5 participants
- Where
- 1 siteItaly
- Study dates
- 4 Nov 2025to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient affected by Degenerative Disc disease undergoing spinal surgery
Who may be able to join
- Signature of the Informed Consent for the study
- Age 30-70 years (included)
- Pfirrmann grade III-V
- Need to undergo spinal surgery
Who cannot join
- Presence of HIV, HBC, HCV or TPHA infection
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, MI, 20157
Stefania Fichera, + 39 0283502229, Stefania.Fichera@grupposandonato.it
About this study
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to data analysis (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start4 Nov 2025
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenrative Disc DiseaseStudies of the same condition, open and under way.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07250126
- Sponsor's protocol ID
- CDP-SUBT
- Other IDs
- GR20250006
- Acronym
- CDP-SUBT
- Status last verified
- Nov 2025
- First submitted
- 18 Nov 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Biomimetic Spine Unit Model Through the Integration of Bioprinting and Transcriptomics (CDP-SUBT)
- ClinicalTrials.gov ID
- NCT07250126
- Acronym / sponsor ID
- CDP-SUBT / CDP-SUBT
- Conditions
- Degenrative Disc Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 4 Nov 2025 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient affected by Degenerative Disc disease undergoing spinal surgery
Key inclusion criteria (4 listed)
- Signature of the Informed Consent for the study
- Age 30-70 years (included)
- Pfirrmann grade III-V
- Need to undergo spinal surgery
Key exclusion criteria (1 listed)
- Presence of HIV, HBC, HCV or TPHA infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Discovery of Tissue-Specific Molecular Markers in Intervertebral Disc Cellular Populations
Time frame: From 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
Related trials for Degenrative Disc Disease
Recruiting
More Realistic Spine Patients: Assessing the Effect of Dialogue Support Tool.
Spinal Stenosis Lumbar, Disc Herniation, Lumbar
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenrative Disc Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discovery of Tissue-Specific Molecular Markers in Intervertebral Disc Cellular Populations (time frame: From enrollment to data analysis (24 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.