Ireland
--:--IST
Active, not recruiting Not applicable

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

NCT05727371 · tracked via the Priya Life Science France tracker
Sponsor
RegenLab France SAS
Phase
Not applicable
Started
2023-08-21
Last updated
2026-02-10

Condition(s) studied

Knee Osteoarthritis

Investigational drug(s) / intervention(s)

Regen Matrix-PRP-XLHAHylan G-F 20Placebo

Regen Matrix-PRP-XLHA: Single intra-articular injection at Day 0

Hylan G-F 20: Single intra-articular injection at Day 0

Placebo: Single intra-articular injection at Day 0

Study 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 Kellgren-Lawrence).

Eligibility

Sex
ALL
Min age
40 Years
Max age
90 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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) * 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

Primary outcome measure(s)

  • Variation in the osteoarthritis related pain — 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

Trial sites (13)

FacilityCityRegionStatus
Hopital Le Bocage Chru Dijon DE
Centre Hospitalier Sud-Francilien Corbeil-Essonnes France
CHU Henri Mondor APHP Créteil France
Centre Hospitalier Départemental Vendée La Roche-sur-Yon France
CHU Limoges Limoges France
Centre Hospitalier Lyon Sud Lyon France
Hopital Lapeyronie Montpellier France
CHU Nantes Hôtel - Dieu Nantes France
Ch de Narbonne Narbonne France
Hôpital Lariboisière Paris France
Hôpital Saint-Antoine Paris France
Hopital Maison Blanche Reims France
Clinique Medipole Garonne, Radiologie Interventionnelle 45 Rue Gironis Toulouse France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05727371 on ClinicalTrials.gov ↗ ← All trials in France