Effects of ASC Secretome on Human Osteochondral Explants

Osteoarthritis Clinical Trial

— ASC-OA  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04223622
• Other study ID #: ASC-OA
• Status: Recruiting
• Start date: April 12, 2021
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
• Contact: Chiara Giannasi
• Phone: 0039 02 83502257
• Email: chiara.giannasi[@]grupposandonato.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Osteoarthritis

Intervention

Biological:
• ASC 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.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Ortopedico Galeazzi	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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-??CT 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