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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fibrin Gel Loaded with Extracellular Vesicles for the Treatment of Cartilage Lesions in the Joints - GelVex Study
- ClinicalTrials.gov ID
- NCT06713902
- Acronym / sponsor ID
- GelVex / GelVex
- Conditions
- Joint Disease
- Keywords
- Cartilage, Mesenchymal Stromal Cells, Extracellular Vesicles, Platelet Rich Plasma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 51 participants (estimated)
- Lead sponsor
- I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Confirm the incorporation rate of extracellular vesicles (EV) into platelet-rich plasma (PRP) following the formation of fibrin gel
Time frame: 2 years
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 39070124Ragni 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Joint Disease, run by I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giuseppe Peretti (+390283502254, enrico.ragni@grupposandonato.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Confirm the incorporation rate of extracellular vesicles (EV) into platelet-rich plasma (PRP) following the formation of fibrin gel (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06713902, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2024.