Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis

Trial details

Who runs it

RegenLab France SAS

Trial code

NCT05727371

Record updated

10 February 2026

Original description

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 full original descriptionShow less

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).

Inclusion: 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.

Exclusion: Knee surgery planned in the next 6 months; 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; Patient affected by autoimmune disease (rheumatoid arthritis, lupus, Hashimoto's disease and Bechterew's syndrome); Patient affected by a knee infection in the past 6 months; History of allergy to hyaluronic acid; Hematologic or clotting disorders (thrombocytopenia) or blood coagulation (deficit-blood dyscrasia); 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; Anemia (HGB<10 g/dl); Tibiofemoral knee osteoarthrosis grade I or II according to the Kellgren and Lawrence grading scale; Chronic inflammatory rheumatism other than arthritis (polyarthrosis, etc.); Clinical signs of local knee inflammation (redness or warmth of the knee joint); Patients with coagulation times outside the reference values; Venous or lymphatic stasis in the corresponding limb; 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.

ClinicalTrials.gov NCT05727371