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ACTIVE NOT RECRUITING
NCT05727371
NA

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

Sponsor: RegenLab France SAS

View on ClinicalTrials.gov

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

Interventions

COMBINATION_PRODUCT

Regen Matrix-PRP-XLHA

Single intra-articular injection at Day 0

DEVICE

Hylan G-F 20

Single intra-articular injection at Day 0

DRUG

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