Effects of ASC Secretome on Human Osteochondral Explants

NCT ID: NCT04223622

Last Updated: 2024-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-04-12

Study Completion Date

2024-07-17

Brief Summary

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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.

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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IRCCS Istituto Ortopedico Galeazzi

Milan, MI, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 31108390 (View on PubMed)

Other Identifiers

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ASC-OA

Identifier Type: -

Identifier Source: org_study_id

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