OsteoarthritisASC-OANCT04223622
Effects of ASC Secretome on Human Osteochondral Explants
An observational study of Osteoarthritis, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
Since the need of finding effective disease-modifying anti-osteoarthritis (OA) treatments is still unmet, with this study the investigators aim to gather further evidences of the therapeutic potential of Mesenchymal Stem/stromal Cell (MSC) secretome in order to pave the way to its future use as a cell-free biological… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- ASC secretome
- How many people
- 36 participants
- Where
- 1 siteItaly
- Study dates
- 12 Apr 2021to 17 Jul 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Upon signing the Informed Consent, 24 male/female patients undergoing orthopedic surgery at IRCCS Istituto Ortopedico Galeazzi and matching the inclusion and esclusion criteria will be recruited.
Who may be able to join
- males and females
- age≥18 years old
- patients hospitalized in IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto Ortopedico Galeazzi, undergoing arthroplasty
Who cannot join
- age<18 years old
- patients unable to sign the Informed Consent
- positivity to serological test (HIV-Human Immunodeficiency Virus, HCV -Hepatitis C Virus, HBV -Hepatitis B Virus and TPHA -Treponema Pallidum Hemagglutination Assay)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Secretome from Mesenchymal Stem/stromal Cells on Human Osteochondral Explants: Cocktail of Factors Secreted by Adipose-derived Stromal Cells (ASC) for the Treatment of Osteoarthritis And/or for Articular Regeneration
Since the need of finding effective disease-modifying anti-osteoarthritis (OA) treatments is still unmet, with this study the investigators aim to gather further evidences of the therapeutic potential of Mesenchymal Stem/stromal Cell (MSC) secretome in order to pave the way to its future use as a cell-free biological product. In detail, the investigators predict to validate the promising results obtained in vitro, ex vivo on osteochondral explants, an OA model more representative of the physiological situation.
- Conditions
- Osteoarthritis
- Being tested
- ASC secretome
- Keywords
- mesenchymal stem/stromal cells, conditioned medium, extracellular vesicles, ASC
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASC secretomeBiological
The osteochondral explants isolated from arthroplasty patients will be induced to an OA phenotype and treated with ASC secretome (either complete conditioned medium or extracellular vesicles) in order to investigate its therapeutic potential.
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of the cell-free approach based on the use of ASC secretome on an ex vivo OA model by evaluation of cell viability, histological features and gene/protein expression of cartilage and bone biomarkers
Biochemical and functional characterization of untreated osteochondral explants (to set up the model) and explants treated with inflammatory cytokines (to simulate osteoarthritic pathology) by evaluation of several parameters. The multiple measurements that will concur to describe the phenotype of the specimens are the following:
- cell viability by AlamarBlue (Arbitrary Fluorescence Units).
- histological assessments (qualitative differences between specimens).
- analysis of gene expression by RT-PCR (real-time polymerase chain reaction, relative quantification by 2-ΔΔCT method).
- analysis of protein expression by Western Blot (relative quantification by densitometry) and Luminex (pg/ml).
Evaluation of the effects of ASC secretome (either complete conditioned medium or its subcomponents) on osteochondral biopsies treated with inflammatory cytokines through the biochemical and functional analyses described above.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start12 Apr 2021
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for OsteoarthritisStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 36 participants (actual)
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
- NCT04223622
- Sponsor's protocol ID
- ASC-OA
- Acronym
- ASC-OA
- Status last verified
- Feb 2024
- First submitted
- 19 Dec 2019
- Last updated
- 22 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Niada S, Giannasi C, Gomarasca M, Stanco D, Casati S, Brini AT. Adipose-derived stromal cell secretome reduces TNFalpha-induced hypertrophy and catabolic markers in primary human articular chondrocytes. Stem Cell Res. 2019 Jul;38:101463. doi: 10.1016/j.scr.2019.101463. Epub 2019 May 15.
PubMed 31108390Cadelano F, Giannasi C, Rossi N, Della Morte E, Niada S, Talo G, Mistretta DA, Moretti M, Peretti GM, Mangiavini L, Brini AT, Choudhery MS. Evaluation of MSC-Secretome Effects in an Ex Vivo Compartmentalized Osteochondral Interface Model. Stem Cells Int. 2026 Jan 31;2026:3275855. doi: 10.1155/sci/3275855. eCollection 2026.
PubMed 41624062
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secretome from Mesenchymal Stem/stromal Cells on Human Osteochondral Explants: Cocktail of Factors Secreted by Adipose-derived Stromal Cells (ASC) for the Treatment of Osteoarthritis And/or for Articular Regeneration
- ClinicalTrials.gov ID
- NCT04223622
- Acronym / sponsor ID
- ASC-OA / ASC-OA
- Conditions
- Osteoarthritis
- Keywords
- mesenchymal stem/stromal cells, conditioned medium, extracellular vesicles, ASC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 12 Apr 2021 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 10 Jan 2020 (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.
Since the need of finding effective disease-modifying anti-osteoarthritis (OA) treatments is still unmet, with this study the investigators aim to gather further evidences of the therapeutic potential of Mesenchymal Stem/stromal Cell (MSC) secretome in order to pave the way to its future use as a cell-free biological product. In detail, the investigators predict to validate the promising results obtained in vitro, ex vivo on osteochondral explants, an OA model more representative of the physiological situation.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Upon signing the Informed Consent, 24 male/female patients undergoing orthopedic surgery at IRCCS Istituto Ortopedico Galeazzi and matching the inclusion and esclusion criteria will be recruited.
Key inclusion criteria (3 listed)
- males and females
- age≥18 years old
- patients hospitalized in IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto Ortopedico Galeazzi, undergoing arthroplasty
Key exclusion criteria (3 listed)
- age<18 years old
- patients unable to sign the Informed Consent
- positivity to serological test (HIV-Human Immunodeficiency Virus, HCV -Hepatitis C Virus, HBV -Hepatitis B Virus and TPHA -Treponema Pallidum Hemagglutination Assay)
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 |
|---|---|---|
| ASC secretomeThe osteochondral explants isolated from arthroplasty patients will be induced to an OA phenotype and treated with ASC secretome (either complete conditioned medium or extracellular vesicles) in order to investigate its therapeutic potential. | Biological | – |
Primary outcome
Validation of the cell-free approach based on the use of ASC secretome on an ex vivo OA model by evaluation of cell viability, histological features and gene/protein expression of cartilage and bone biomarkers
Time frame: 3 years
Biochemical and functional characterization of untreated osteochondral explants (to set up the model) and explants treated with inflammatory cytokines (to simulate osteoarthritic pathology) by evaluation of several parameters. The multiple measurements that will concur to describe the phenotype of the specimens are the following: * cell viability by AlamarBlue (Arbitrary Fluorescence Units). * histological assessments (qualitative differences between specimens). * analysis of gene expression by RT-PCR (real-time polymerase chain reaction, relative quantification by 2-ΔΔCT method). * analysis of protein expression by Western Blot (relative quantification by densitometry) and Luminex (pg/ml). Evaluation of the effects of ASC secretome (either complete conditioned medium or its subcomponents) on osteochondral biopsies treated with inflammatory cytokines through the biochemical and functional analyses described above.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2024.
- Background: PubMed 31108390Niada S, Giannasi C, Gomarasca M, Stanco D, Casati S, Brini AT. Adipose-derived stromal cell secretome reduces TNFalpha-induced hypertrophy and catabolic markers in primary human articular chondrocytes. Stem Cell Res. 2019 Jul;38:101463. doi: 10.1016/j.scr.2019.101463. Epub 2019 May 15.
- Derived from this study: PubMed 41624062Cadelano F, Giannasi C, Rossi N, Della Morte E, Niada S, Talo G, Mistretta DA, Moretti M, Peretti GM, Mangiavini L, Brini AT, Choudhery MS. Evaluation of MSC-Secretome Effects in an Ex Vivo Compartmentalized Osteochondral Interface Model. Stem Cells Int. 2026 Jan 31;2026:3275855. doi: 10.1155/sci/3275855. eCollection 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Osteoarthritis, 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 22 Oct 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of the cell-free approach based on the use of ASC secretome on an ex vivo OA model by evaluation of cell viability, histological features and gene/protein expression of cartilage and bone biomarkers (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04223622, which also lists 2 linked publications.
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 22 Oct 2024.