Knee OsteoarthritisNCT05727371
Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis
A study testing Regen Matrix-PRP-XLHA and Hylan G-F 20 in people with Knee Osteoarthritis, run by RegenLab France SAS at 13 sites in France.
Trial summary
In this clinical trial the investigator assess the safety and efficacy of a single injection of a combination of cross-linked hyaluronic acid (HA) with autologous platelet-rich plasma (PRP) obtained with the RegenMatrix medical device to improve symptoms of moderate to severe knee osteoarthitis (grade III-IV… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Regen Matrix-PRP-XLHA and Hylan G-F 20
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 13 sitesFrance
- Study dates
- 21 Aug 2023to 30 Aug 2026
- Phase
- Interventional
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tibiofemoral knee osteoarthrosis according to ACR criteria
- Tibiofemoral knee osteoarthrosis grade 3-4 according to the Kellgren \& Lawrence grading scale, as defined on knee radiographs (less than 3 months old: face view, schuss view, profile and patellar axial view at 30°)
- Symptomatic knee osteoarthrosis as evidenced by pain on walking (WOMAC A1 assessed in the last 24 hours on a scale of 0 to 100 mm: 50 ≤ DM 90 or reduced joint function (WOMAC C total score assessed or within the previous 24 hours based on a scale of 0-100-mm: 50 ≤ WOMAC C ≤ 90)
- Patient able to understand the requirements of the trial and who has signed a free and informed consent prior to study entry
- Patient able to read and understand the written instructions
- Patient able to complete the self-assessment questionnaires
Who cannot join
- Tibiofemoral knee osteoarthrosis grade I or II according to the Kellgren and Lawrence grading scale
- Knee surgery planned in the next 6 months
- Patient affected by autoimmune disease (rheumatoid arthritis, lupus, Hashimoto's disease and Bechterew's syndrome)
- Chronic inflammatory rheumatism other than arthritis (polyarthrosis, etc.)
- Patient affected by a knee infection in the past 6 months
- Clinical signs of local knee inflammation (redness or warmth of the knee joint)
Show all 25Show fewer
- Last PRP or PRP/HA injection received in the last year
- Last viscosupplementation received in the past 6 months
- Last corticosteroid injection received in the past 3 months
- Use of gluco-corticosteroids (except inhaled) and level III analgesics in the last 3 months and non-steroidal anti-inflammatory drug in the last 2 weeks
- Treatment with AAAL initiated within the last 6 months
- History of allergy to hyaluronic acid
- Hematologic or clotting disorders (thrombocytopenia) or blood coagulation (deficit-blood dyscrasia)
- Patients with coagulation times outside the reference values
- Anemia (HGB<10 g/dl)
- Venous or lymphatic stasis in the corresponding limb
- Malignant diseases (especially bone or haematological)
- Patients with serious, no-stabilized pathologies (cardiovascular disease, active peptic ulcer, digestive hemorrhage)
- Acute infection
- Patients with cancer or with an immuno-deprassant treatment ongoing
- Participation in another clinical trial for osteoarthritis of the knee in the last year
- Participation in another clinical trial, ongoing or completed within the last 3 months
- Patient unable to comply with the constraints of the protocol, in particular a patient whose mental state does not allow him/her to patient's mental state does not allow him/her to understand the nature, objectives and possible consequences of the study
- Pregnant or breastfeeding women or women who expect to become pregnant during the study
- Any other reason which may interfere with the proper conduct of the study, in the investigator's opinion
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
France13 sites
Centre Hospitalier Sud-Francilien
Corbeil-Essonnes
CHU Henri Mondor APHP
Créteil
Hopital Le Bocage Chru
Dijon, DE, 21079
Centre Hospitalier Départemental Vendée
La Roche-sur-Yon
CHU Limoges
Limoges
Centre Hospitalier Lyon Sud
Lyon
Hopital Lapeyronie
Montpellier, 34295
CHU Nantes Hôtel - Dieu
Nantes
Ch de Narbonne
Narbonne
Hôpital Lariboisière
Paris
Hôpital Saint-Antoine
Paris
Hopital Maison Blanche
Reims, 51092
Clinique Medipole Garonne, Radiologie Interventionnelle 45 Rue Gironis
Toulouse, 31100
About this study
Official title: Multicenter, Randomized Double-blind Study to Compare the Safety and Performance of a Combination of A-PRP and XLHA Prepared With the RegenMatrix Medical Device, to Hylan G-F 20 XLHA and Placebo to Treat Moderate/Severe Knee Osteoarthritis
In this clinical trial the investigator assess the safety and efficacy of a single injection of a combination of cross-linked hyaluronic acid (HA) with autologous platelet-rich plasma (PRP) obtained with the RegenMatrix medical device to improve symptoms of moderate to severe knee osteoarthitis (grade III-IV Kellgren-Lawrence).
Read the detailed description
In this multicenter, randomized, double-blind, three-arm study, the investigator propose to evaluate the safety and efficacy at Day0, Month1, Month3 and Month6 of a single intra-articular injection of a combination RM-PRP-XLHA (experimental treatment: combination of cross-linked HA and PRP obtained with the RegenMatrix medical device) against Hylan G-F 20 (reference treatment) and placebo for the treatment of moderate to severe knee osteoarthritis.
The symptomatic benefit will be evaluated in terms of pain reduction and improvement of patient's quality of life. The functional benefit of the treatment will also be evaluated, on a reduced number of participants, by a gait analysis, performed only in the coordinating centre.
The medical device RegenMatrix is an adaptation of the medical device Cellular Matrix (certified since 2013,CE2797). It differs from the latter only for by presence of cross-linked HA instead of linear HA, and is therefore particularly suitable for the treatment of moderate to severe knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- Regen Matrix-PRP-XLHA, Hylan G-F 20, Placebo
- Keywords
- platelet-rich plasma, cross-linked hyaluronic acid, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regen Matrix-PRP-XLHACombination product
Single intra-articular injection at Day 0
Hylan G-F 20Device
Single intra-articular injection at Day 0
PlaceboDrug
Single intra-articular injection at Day 0
| Study group | Role | What they receive |
|---|---|---|
| RegenMatrix-PRP-XLHA | Experimental | Patients randomized in this group will receive a single injection of a combination of platelet-rich plasma plus cross-linked hyaluronic acid, prepared with the medical device RegenMatrix. Receives: Combination Product: Regen Matrix-PRP-XLHA |
| Hylan G-F 20 | Active comparator | Patients randomized in this group will receive a single injection of cross-linked hyaluronic acid Hylan G-F 20 (Synvisc-One®). Receives: Device: Hylan G-F 20 |
| Placebo | Placebo comparator | Patients randomized in this group will receive a single injection of saline solution (0.9% NaCl) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in the osteoarthritis related pain
It will be assessed by the mean difference in the WOMAC A score on a 100-mm VAS overtime
Measured: 6 months (Day 0 - Month 6)
Secondary outcomes (9)
Variation in the overall osteoarthritis related pain
It will be assessed by the mean difference in the WOMAC A score on a 100-mm VAS overtime
Measured: M1 and M3 (Day 0-Month 1; Day 0 - Month 3)
Variation of joint stiffness after the first awakening and later in the day
It will be assessed by the mean difference in the WOMAC B score overtime
Measured: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Variation of joint function during daily activity
It will be assessed by the mean difference in the WOMAC C score overtime
Measured: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Variation in the osteoarthritis related symptoms
It will be assessed by the mean difference in the total WOMAC score Month 1, Month 3 and M6 (D0-M1; D0-M3; D0-M6)
Measured: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Variation of patient's quality of life
It will be assessed by the SF-12 questionnaire
Measured: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Pain, function, patient's general assessment
It will be assessed by the% of OMERACT-OARSI responders
Measured: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Assessment of the minimal meaningful change according to the patient's perception
The Minimal Clinically Important Improvement (MCII) will be assessed on the basis of the answers to the WOMAC questionnaire.
Measured: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Assessment of the highest level of symptom beyond which patients consider themselves well.
The Patient Acceptable Symptom State (PASS) will be assessed on the basis of the answers to the WOMAC questionnaire.
Measured: Month 1, Month 3 and Month 6 (D0-Month 1; Day 0-Month 3; Day 0-Month 6)
Rescue medication
Consumption of level 1 and 2 painkillers, NSAIDs and corticosteroids
Measured: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start21 Aug 2023
- Primary completion28 Feb 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.
- Other trials for Knee OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RegenLab France SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul Ornetti, MD, Principal investigator, Centre Hospitalier Universitaire Dijon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727371
- Sponsor's protocol ID
- 2022-A01514-39
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2023
- Last updated
- 10 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized Double-blind Study to Compare the Safety and Performance of a Combination of A-PRP and XLHA Prepared With the RegenMatrix Medical Device, to Hylan G-F 20 XLHA and Placebo to Treat Moderate/Severe Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT05727371
- Acronym / sponsor ID
- 2022-A01514-39
- Conditions
- Knee Osteoarthritis
- Keywords
- platelet-rich plasma, cross-linked hyaluronic acid, knee osteoarthritis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- RegenLab France SASIndustry (pharma, biotech, devices)
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 28 Feb 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 14 Feb 2023 (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.
In this clinical trial the investigator assess the safety and efficacy of a single injection of a combination of cross-linked hyaluronic acid (HA) with autologous platelet-rich plasma (PRP) obtained with the RegenMatrix medical device to improve symptoms of moderate to severe knee osteoarthitis (grade III-IV Kellgren-Lawrence).
Detailed description
In this multicenter, randomized, double-blind, three-arm study, the investigator propose to evaluate the safety and efficacy at Day0, Month1, Month3 and Month6 of a single intra-articular injection of a combination RM-PRP-XLHA (experimental treatment: combination of cross-linked HA and PRP obtained with the RegenMatrix medical device) against Hylan G-F 20 (reference treatment) and placebo for the treatment of moderate to severe knee osteoarthritis.
The symptomatic benefit will be evaluated in terms of pain reduction and improvement of patient's quality of life. The functional benefit of the treatment will also be evaluated, on a reduced number of participants, by a gait analysis, performed only in the coordinating centre.
The medical device RegenMatrix is an adaptation of the medical device Cellular Matrix (certified since 2013,CE2797). It differs from the latter only for by presence of cross-linked HA instead of linear HA, and is therefore particularly suitable for the treatment of moderate to severe knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RegenMatrix-PRP-XLHA | Experimental | Combination Product: Regen Matrix-PRP-XLHAPatients randomized in this group will receive a single injection of a combination of platelet-rich plasma plus cross-linked hyaluronic acid, prepared with the medical device RegenMatrix. |
| Hylan G-F 20 | Active comparator | Device: Hylan G-F 20Patients randomized in this group will receive a single injection of cross-linked hyaluronic acid Hylan G-F 20 (Synvisc-One®). |
| Placebo | Placebo comparator | Drug: PlaceboPatients randomized in this group will receive a single injection of saline solution (0.9% NaCl) |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Tibiofemoral knee osteoarthrosis according to ACR criteria
- Tibiofemoral knee osteoarthrosis grade 3-4 according to the Kellgren \& Lawrence grading scale, as defined on knee radiographs (less than 3 months old: face view, schuss view, profile and patellar axial view at 30°)
- Symptomatic knee osteoarthrosis as evidenced by pain on walking (WOMAC A1 assessed in the last 24 hours on a scale of 0 to 100 mm: 50 ≤ DM 90 or reduced joint function (WOMAC C total score assessed or within the previous 24 hours based on a scale of 0-100-mm: 50 ≤ WOMAC C ≤ 90)
- Patient able to understand the requirements of the trial and who has signed a free and informed consent prior to study entry
- Patient able to read and understand the written instructions
Key exclusion criteria (25 listed)
- Tibiofemoral knee osteoarthrosis grade I or II according to the Kellgren and Lawrence grading scale
- Knee surgery planned in the next 6 months
- Patient affected by autoimmune disease (rheumatoid arthritis, lupus, Hashimoto's disease and Bechterew's syndrome)
- Chronic inflammatory rheumatism other than arthritis (polyarthrosis, etc.)
- Patient affected by a knee infection in the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Regen Matrix-PRP-XLHASingle intra-articular injection at Day 0 | Combination product | RegenMatrix-PRP-XLHA |
| Hylan G-F 20Single intra-articular injection at Day 0 | Device | Hylan G-F 20 |
| PlaceboSingle intra-articular injection at Day 0 | Drug | Placebo |
Primary outcome
Variation in the osteoarthritis related pain
Time frame: 6 months (Day 0 - Month 6)
It will be assessed by the mean difference in the WOMAC A score on a 100-mm VAS overtime
9 secondary outcomes
Variation in the overall osteoarthritis related pain
Time frame: M1 and M3 (Day 0-Month 1; Day 0 - Month 3)
Variation of joint stiffness after the first awakening and later in the day
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Variation of joint function during daily activity
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Variation in the osteoarthritis related symptoms
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Variation of patient's quality of life
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Pain, function, patient's general assessment
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Assessment of the minimal meaningful change according to the patient's perception
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Assessment of the highest level of symptom beyond which patients consider themselves well.
Time frame: Month 1, Month 3 and Month 6 (D0-Month 1; Day 0-Month 3; Day 0-Month 6)
Rescue medication
Time frame: Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
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 10 Feb 2026.
- 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. This study is not recruiting at the moment.
Paul Ornetti, MD principal investigator
Centre Hospitalier Universitaire Dijon
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regen Matrix-PRP-XLHA and Hylan G-F 20 in people with Knee Osteoarthritis, run by RegenLab France SAS at 13 sites in France.
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 6 inclusion and 25 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: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in France. 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. Some participants in this study may receive a placebo. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in the osteoarthritis related pain (time frame: 6 months (Day 0 - Month 6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Feb 2026.