NCT05727371

Brief 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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
4mo left

Started Aug 2023

Longer than P75 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

13 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Aug 2023Aug 2026

First Submitted

Initial submission to the registry

January 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 14, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

August 21, 2023

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Expected
Last Updated

February 10, 2026

Status Verified

February 1, 2026

Enrollment Period

2.5 years

First QC Date

January 9, 2023

Last Update Submit

February 6, 2026

Conditions

Knee Osteoarthritis

Keywords

platelet-rich plasmacross-linked hyaluronic acidknee osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Variation in the osteoarthritis related pain

    It will be assessed by the mean difference in the WOMAC A score on a 100-mm VAS overtime

    6 months (Day 0 - Month 6)

Secondary Outcomes (9)

  • Variation in the overall osteoarthritis related pain

    M1 and M3 (Day 0-Month 1; Day 0 - Month 3)

  • Variation of joint stiffness after the first awakening and later in the day

    Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)

  • Variation of joint function during daily activity

    Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)

  • Variation in the osteoarthritis related symptoms

    Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)

  • Variation of patient's quality of life

    Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)

  • +4 more secondary outcomes

Study Arms (3)

RegenMatrix-PRP-XLHA

EXPERIMENTAL

Patients randomized in this group will receive a single injection of a combination of platelet-rich plasma plus cross-linked hyaluronic acid, prepared with the medical device RegenMatrix.

Combination Product: Regen Matrix-PRP-XLHA

Hylan G-F 20

ACTIVE COMPARATOR

Patients randomized in this group will receive a single injection of cross-linked hyaluronic acid Hylan G-F 20 (Synvisc-One®).

Device: Hylan G-F 20

Placebo

PLACEBO COMPARATOR

Patients randomized in this group will receive a single injection of saline solution (0.9% NaCl)

Drug: Placebo

Interventions

Regen Matrix-PRP-XLHACOMBINATION_PRODUCT

Single intra-articular injection at Day 0

RegenMatrix-PRP-XLHA
Hylan G-F 20DEVICE

Single intra-articular injection at Day 0

Hylan G-F 20
PlaceboDRUG

Single intra-articular injection at Day 0

Placebo

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Hopital Le Bocage Chru

Dijon, DE, 21079, France

Location

Centre Hospitalier Sud-Francilien

Corbeil-Essonnes, France

Location

CHU Henri Mondor APHP

Créteil, France

Location

Centre Hospitalier Départemental Vendée

La Roche-sur-Yon, France

Location

CHU Limoges

Limoges, France

Location

Centre Hospitalier Lyon Sud

Lyon, France

Location

Hopital Lapeyronie

Montpellier, 34295, France

Location

CHU Nantes Hôtel - Dieu

Nantes, France

Location

Ch de Narbonne

Narbonne, France

Location

Hôpital Lariboisière

Paris, France

Location

Hôpital Saint-Antoine

Paris, France

Location

Hopital Maison Blanche

Reims, 51092, France

Location

Clinique Medipole Garonne, Radiologie Interventionnelle 45 Rue Gironis

Toulouse, 31100, France

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Paul Ornetti, MD

    Centre Hospitalier Universitaire Dijon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

February 14, 2023

Study Start

August 21, 2023

Primary Completion

February 28, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

February 10, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(13)