Effects of ASC Secretome on Human Osteochondral Explants

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04223622

Acronym

ASC-OA

Enrollment

Registered

2020-01-10

Start date

2021-04-12

Completion date

2024-07-17

Last updated

2024-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis

Keywords

mesenchymal stem/stromal cells, conditioned medium, extracellular vesicles, ASC

Brief 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 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.

Interventions

BIOLOGICALASC secretome

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.

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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	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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026