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Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis
Sponsor: RegenLab France SAS
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).
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
Key Details
Gender
All
Age Range
40 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
280
Start Date
2023-08-21
Completion Date
2026-08-30
Last Updated
2026-02-10
Healthy Volunteers
No
Conditions
Interventions
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
Locations (13)
Hopital Le Bocage Chru
Dijon, DE, France
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