Effects of ASC Secretome on Human Osteochondral Explants

NCT04223622 | Completed

• 1 other identifier: ASC-OA
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  3 years

Interventions

ASC secretome BIOLOGICAL

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• males and females
• age≥18 years old
• patients hospitalized in IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico) Istituto Ortopedico Galeazzi, undergoing arthroplasty

You may not qualify if:

• 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)

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Istituto Ortopedico Galeazzi

Milan, MI, 20161, Italy

Location

Related Publications (2)

• 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.

  PMID: 31108390 BACKGROUND

• Cadelano 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.

  PMID: 41624062 DERIVED

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2019
• First Posted: January 10, 2020
• Study Start: April 12, 2021
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: October 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)