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

NCT05727371 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-02-10

No results posted yet for this 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).

Conditions

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

Sponsors & Collaborators

  • RegenLab France SAS

    lead INDUSTRY

Principal Investigators

  • Paul Ornetti, MD · Centre Hospitalier Universitaire Dijon

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-21
Primary Completion
2026-02-28
Completion
2026-08-30

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05727371 on ClinicalTrials.gov