- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04223622
Effects of ASC Secretome on Human Osteochondral Explants (ASC-OA)
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
Study Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chiara Giannasi
- Phone Number: 0039 02 83502257
- Email: chiara.giannasi@grupposandonato.it
Study Locations
-
-
MI
-
Milano, MI, Italy, 20161
- Recruiting
- IRCCS Istituto Ortopedico Galeazzi
-
Contact:
- Chiara Giannasi
- Email: chiara.giannasi@grupposandonato.it
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- males and females
- age≥18 years old
- patients hospitalized in IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto Ortopedico Galeazzi, undergoing arthroplasty
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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:
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. |
3 years
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ASC-OA
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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