Investigating the effects of mesenchymal stem cells on degenerative disc disease using a human spine model
Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT): Targeting Degeneration With Cell Secretome
This study is testing if special cells from bone marrow can help improve the health of spinal discs affected by aging and inflammation in people with degenerative disc disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio Academic / other |
| Locations | 2 sites (Milan, MI and 1 other locations) |
| Trial ID | NCT06490887 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the response of a human organotypic model of the spine unit to treatment with mesenchymal stem cell (MSC)-derived secretome in the context of degenerative disc disease (DDD). By creating a 3D in vitro representation of the spine, researchers will assess how MSC-derived factors can modulate gene expression altered by inflammation. Additionally, the study seeks to identify degenerative features associated with aging and inflammation in DDD patients and develop a model using patient-derived cells to further investigate cellular responses to inflammation.
Who should consider this trial
Good fit: Ideal candidates include patients aged 30-60 with degenerative disc disease requiring spinal surgery.
Not a fit: Patients with active infections such as HIV, HBV, HCV, or TP will not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to new therapeutic strategies for treating degenerative disc disease and improving patient outcomes.
How similar studies have performed: While the approach of using organotypic models is established, the specific application to DDD with MSC-derived secretome is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
DDD patients: * Signature of the Informed Consent for the study * Age 30-60 years (included) * Pfirrmann grade III-V * Need to undergo spinal surgery Subjects for the isolation of adipose-derived MSCs: * Signature of the Informed Consent for the study * Age 18-50 (included) * Need to undergo surgery that involves the removal of adipose tissue Subjects for the isolation of placenta-derived MSCs: * Signature of the Informed Consent for the study * Age 18-50 (included) * Women who are pregnant or who have not given birth from more than 6 hours All enrolled subjects: \- Presence of HIV, HBV, HCV or TP infection
Where this trial is running
Milan, MI and 1 other locations
- IRCCS Ospedale Galeazzi-Sant'Ambrogio — Milan, Mi, Italy (Recruiting)
- IStituto MEditerraneo per i Trapianti e Terapie ad alta specializzazione — Palermo, Italy (Not_yet_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.