Degenerative Disc DiseaseSUITNCT06490887
Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT)
An observational study of Degenerative Disc Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
Trial summary
Ageing and inflammation represent two main drivers of DDD, a progressive, chronic condition involving vertebral bone, cartilaginous endplate and intervertebral disc. In vitro investigation of the DDD-associated processes on single compartments of the spine unit or ex vivo animal models fail in recapitulating the… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Degenerative Disc Disease
- What is being tested?
- Use of patient-derived biological samples
- How many people
- 20 participants
- Where
- 2 sitesItaly
- Study dates
- 28 Jun 2023to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Samples will be collected from Degenerative Disc Disease patients undergoing spine surgery, from patients subjected to surgeries that involve the removal of adipose tissue and from pregnant women within 6 hours from giving birth.
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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 2 recruiting
- Recruiting
IRCCS Ospedale Galeazzi-Sant'Ambrogio
Milan, MI, 20157
Matteo Moretti, PhD, 0039 0283502220, matteo.moretti@grupposandonato.it
- Not yet recruiting
IStituto MEditerraneo per i Trapianti e Terapie ad alta specializzazione
Palermo, 90127
Matteo Bulati, PhD, 0039 0912192496, mbulati@ismett.edu
About this study
Official title: Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT): Targeting Degeneration With Cell Secretome
Ageing and inflammation represent two main drivers of DDD, a progressive, chronic condition involving vertebral bone, cartilaginous endplate and intervertebral disc.
In vitro investigation of the DDD-associated processes on single compartments of the spine unit or ex vivo animal models fail in recapitulating the complex spine pathophysiology or suffer from inter-species differences. Given these premises, a human organotypic model of the spine unit would represent a suitable tool to investigate the DDD-related pathways and to screen promising treatments such as MSC-based therapies.
Read the detailed description
The primary aim of this study is to investigate the response of an inflamed organotypic spine unit model, intended as a 3D in vitro representation of an in vivo environment, to the treatment with mesenchymal stem cells (MSC)-derived secretome. In particular to investigate the ability of MSC-derived secretome to modulate genes found to be upregulated or downregulated by the inflammatory stimulation in the spine unit model and bring their expression back to a basal state.
Secondary aims of the study are:
- To identify specific degenerative features related to ageing and inflammation in patients affected by Degenerative Disc Disease (DDD) correlating circulating features and tissue degeneration
- To develop an organotypic spine unit model using patient-derived cells to investigate the response of cells derived from nucleus pulposus (NP), annulus fibrosus (AF) and cartilaginous endplate (CEP) to inflammation
- Conditions
- Degenerative Disc Disease
- Being tested
- Use of patient-derived biological samples
- Keywords
- inflammation, degeneration, spine unit, intervertebral disc, mesenchymal stem cell
- Medical subject headings
- Intervertebral Disc Degeneration, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of patient-derived biological samplesOther
We will use biological samples that are routinely collected as waste material from patients undergoing surgery or from pregnant women giving birth. Peripheral blood will be also collected from patients to conduct virological screening and isolate peripheral blood mononuclear cells.
| Study group | Role | What they receive |
|---|---|---|
| Degenerative Disc Disease patients undergoing spine surgery | Collection of blood. Collection of nucleous pulposus, annulus fibrosus and cartilaginous endplate biopsies that would be considered as waste material after surgery. Receives: Other: Use of patient-derived biological samples | |
| Subjects undergoing plastic surgery | Collection of adipose tissue that would be considered as waste material after surgery. Receives: Other: Use of patient-derived biological samples | |
| Pregnant female subjects | Collection of amnion of human term placenta (38-40 weeks of gestation) within 6 hours of birth. Receives: Other: Use of patient-derived biological samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of MSC-derived secretome
Changes in gene expression in response to the treatment of the spine unit model with MSC-derived secretome. If the MSC-derived secretome is effective, genes upregulated or downregulated by inflammatory stimulation are expected to go back to their basal levels when the inflamed model is treated with MSC-derived secretome.
Measured: 30 months
Secondary outcomes (2)
Characterization of patient-specific degenerative features
Identification of circulating degenerative features related to ageing and inflammation in patients affected by Degenerative Disc Disease (DDD) correlating with tissue degeneration.
Measured: 30 months
Development of an organotypic spine unit model
Determination of success or failure in the development of spine unit models for each enrolled patient from which cell isolation has been successful.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start28 Jun 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 20 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
- NCT06490887
- Sponsor's protocol ID
- SUIT
- Acronym
- SUIT
- Status last verified
- Jul 2024
- First submitted
- 28 Mar 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spine Unit Modelling Coupled With hIgh Throughput Analysis (SUIT): Targeting Degeneration With Cell Secretome
- ClinicalTrials.gov ID
- NCT06490887
- Acronym / sponsor ID
- SUIT / SUIT
- Conditions
- Degenerative Disc Disease
- Keywords
- inflammation, degeneration, spine unit, intervertebral disc, mesenchymal stem cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 8 Jul 2024 (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.
Ageing and inflammation represent two main drivers of DDD, a progressive, chronic condition involving vertebral bone, cartilaginous endplate and intervertebral disc.
In vitro investigation of the DDD-associated processes on single compartments of the spine unit or ex vivo animal models fail in recapitulating the complex spine pathophysiology or suffer from inter-species differences. Given these premises, a human organotypic model of the spine unit would represent a suitable tool to investigate the DDD-related pathways and to screen promising treatments such as MSC-based therapies.
Detailed description
The primary aim of this study is to investigate the response of an inflamed organotypic spine unit model, intended as a 3D in vitro representation of an in vivo environment, to the treatment with mesenchymal stem cells (MSC)-derived secretome. In particular to investigate the ability of MSC-derived secretome to modulate genes found to be upregulated or downregulated by the inflammatory stimulation in the spine unit model and bring their expression back to a basal state.
Secondary aims of the study are:
- To identify specific degenerative features related to ageing and inflammation in patients affected by Degenerative Disc Disease (DDD) correlating circulating features and tissue degeneration
- To develop an organotypic spine unit model using patient-derived cells to investigate the response of cells derived from nucleus pulposus (NP), annulus fibrosus (AF) and cartilaginous endplate (CEP) to inflammation
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Degenerative Disc Disease patients undergoing spine surgery | – | Other: Use of patient-derived biological samplesCollection of blood. Collection of nucleous pulposus, annulus fibrosus and cartilaginous endplate biopsies that would be considered as waste material after surgery. |
| Subjects undergoing plastic surgery | – | Other: Use of patient-derived biological samplesCollection of adipose tissue that would be considered as waste material after surgery. |
| Pregnant female subjects | – | Other: Use of patient-derived biological samplesCollection of amnion of human term placenta (38-40 weeks of gestation) within 6 hours of birth. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Samples will be collected from Degenerative Disc Disease patients undergoing spine surgery, from patients subjected to surgeries that involve the removal of adipose tissue and from pregnant women within 6 hours from giving birth.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of patient-derived biological samplesWe will use biological samples that are routinely collected as waste material from patients undergoing surgery or from pregnant women giving birth. Peripheral blood will be also collected from patients to conduct virological screening and isolate peripheral blood mononuclear cells. | Other | Degenerative Disc Disease patients undergoing spine surgery, Pregnant female subjects, Subjects undergoing plastic surgery |
Primary outcome
Efficacy of MSC-derived secretome
Time frame: 30 months
Changes in gene expression in response to the treatment of the spine unit model with MSC-derived secretome. If the MSC-derived secretome is effective, genes upregulated or downregulated by inflammatory stimulation are expected to go back to their basal levels when the inflamed model is treated with MSC-derived secretome.
2 secondary outcomes
Characterization of patient-specific degenerative features
Time frame: 30 months
Development of an organotypic spine unit model
Time frame: 30 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
IStituto MEditerraneo per i Trapianti e Terapie ad alta specializzazione
Palermo, Italy
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degenerative Disc Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Efficacy of MSC-derived secretome (time frame: 30 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 8 Jul 2024.