Joint DiseaseGelVexNCT06713902
Extracellular Vesicles in Fibrin Gel for Cartilage Repair
An observational study of Joint Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
Trial summary
This project aims to produce and study in vitro/ex vivo a platelet rich plasma (PRP)-derived fibrin gel loaded with mesenchymal stromal cells (MSC)-extracellular vesicles (EVs), to combine the positive results on cartilage growth of PRP growth factors and the hyaline cartilage stimulating activity of MSC-EVs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Disease
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 29 Oct 2024to 30 Aug 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Upon signing the Informed Consent, 51 male and female subjects, ≥ 18 years old, attending the IRCCS Galeazzi-Sant'Ambrogio Hospital and matching the inclusion and esclusion criteria will be recruited.
Who may be able to join
- males and females ≥ 18
- patients undergoing plastic surgery procedures;
- patients undergoing elective joint surgery with a diagnosis of knee or hip osteoarthritis (any Kellgren-Lawrence grade);
- patients undergoing regenerative medicine treatments with PRP with a diagnosis of knee or hip osteoarthritis (any Kellgren-Lawrence grade;
- signed Informed Consent for the study
Who cannot join
- Positive virological test (HIV, HCV, HBV, TPHA)
- Pregnancy or breastfeeding by self-declaration
- Other conditions that, at the discretion of the investigator or the physician
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Milan, MI, 20157
Direzione Scientifica, 00390283502224, direzionescientifica.ogsa@grupposandonato.it
About this study
Official title: Fibrin Gel Loaded with Extracellular Vesicles for the Treatment of Cartilage Lesions in the Joints - GelVex Study
This project aims to produce and study in vitro/ex vivo a platelet rich plasma (PRP)-derived fibrin gel loaded with mesenchymal stromal cells (MSC)-extracellular vesicles (EVs), to combine the positive results on cartilage growth of PRP growth factors and the hyaline cartilage stimulating activity of MSC-EVs. Therefore, the project goal is to provide an advanced option for orthopedic patients with an innovative evolution of a gold standard procedure, making it easy to translate into daily clinical practice for physicians, healthcare professionals and patients.
- Conditions
- Joint Disease
- Keywords
- Cartilage, Mesenchymal Stromal Cells, Extracellular Vesicles, Platelet Rich Plasma
- Medical subject headings
- Joint Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fifty-one m/f patients matching the inclusion and exclusion criteria | Six patients undergoing plastic surgery procedures for the removal of adipose tissue from which waste material (adipose tissue) will be taken to obtain MSCs for EVs production. Five patients undergoing hip or knee joint replacement surgery from which waste material (osteo-cartilaginous material) will be taken to obtain chondrocytes for functional tests. Forty patients undergoing regenerative medicine treatments with PRP from which a waste aliquot (obtained during PRP preparation) will be taken to obtain plasma for fibrin gel production. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Confirm the incorporation rate of extracellular vesicles (EV) into platelet-rich plasma (PRP) following the formation of fibrin gel
To implement the preliminary data obtained by the PI in the development of a protocol to achieve efficient incorporation of mesenchymal stem cell-derived extracellular vesicles into platelet-rich plasma-derived fibrin gels and characterize their release. MSC-EVs will be embedded in fibrin gel using PRP provided by patients enrolled in the study that is activated to obtain the solid form. To monitor the incorporation and release of EVs from the PRP-gel, EVs will be labeled with a fluorescent marker to allow their subsequent detection by cytometry or imaging methods. The ability of the released EVs to be incorporated into human chondrocytes and penetrate cartilage will be tested using three in vitro models: i) flow cytometry in a 2D culture model; ii) a 3D microfluidic model; iii) a Quantitative Imaging with cartilage explants. Biological activity will be tested on pathological chondrocytes.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start29 Oct 2024
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Joint DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 51 participants (estimated)
Sponsor and investigators
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06713902
- Sponsor's protocol ID
- GelVex
- Acronym
- GelVex
- Status last verified
- Nov 2024
- First submitted
- 27 Nov 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ragni E, De Luca P, Landoni S, Valli F, Mortati L, Palombella S, Talo G, Moretti M, de Girolamo L. High efficiency protocol for platelet derived fibrin gel loaded with mesenchymal stromal cells extracellular vesicles. Regen Ther. 2024 Jul 7;26:442-457. doi: 10.1016/j.reth.2024.06.020. eCollection 2024 Jun.
PubMed 39070124