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

Knee Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05727371
• Other study ID #: 2022-A01514-39
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2023
• Est. completion date: August 21, 2025

Study information

• Verified date: August 2023
• Source: Regen Lab SA
• Contact: Bruno Boezennec, MD
• Phone: +33 (0) 642 93 92 00
• Email: bboezennec[@]regenlab.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

In this multicenter, randomized, double-blind, three-arm study, the investigator propose to evaluate the safety and efficacy at Day0, Month1, Month3 and Month6 of a single intra-articular injection of a combination RM-PRP-XLHA (experimental treatment: combination of cross-linked HA and PRP obtained with the RegenMatrix medical device) against Hylan G-F 20 (reference treatment) and placebo for the treatment of moderate to severe knee osteoarthritis.

The symptomatic benefit will be evaluated in terms of pain reduction and improvement of patient's quality of life. The functional benefit of the treatment will also be evaluated, on a reduced number of participants, by a gait analysis, performed only in the coordinating centre.

The medical device RegenMatrix is an adaptation of the medical device Cellular Matrix (certified since 2013,CE2797). It differs from the latter only for by presence of cross-linked HA instead of linear HA, and is therefore particularly suitable for the treatment of moderate to severe knee osteoarthritis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: August 21, 2025
• Est. primary completion date: February 21, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Country	Name	City	State
France	Hopital Le Bocage Chru	Dijon	DE
France	Hopital Lapeyronie	Montpellier
France	Clinique Medipole Garonne, Radiologie Interventionnelle 45 Rue Gironis	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
RegenLab France SAS

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Variation in the overall osteoarthritis related pain	It will be assessed by the mean difference in the WOMAC A score on a 100-mm VAS overtime	M1 and M3 (Day 0-Month 1; Day 0 - Month 3)
Secondary	Variation of joint stiffness after the first awakening and later in the day	It will be assessed by the mean difference in the WOMAC B score overtime	Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Secondary	Variation of joint function during daily activity	It will be assessed by the mean difference in the WOMAC C score overtime	Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Secondary	Variation in the osteoarthritis related symptoms	It will be assessed by the mean difference in the total WOMAC score Month 1, Month 3 and M6 (D0-M1; D0-M3; D0-M6)	Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Secondary	Variation of patient's quality of life	It will be assessed by the SF-12 questionnaire	Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Secondary	Pain, function, patient's general assessment	It will be assessed by the% of OMERACT-OARSI responders	Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Secondary	Assessment of the minimal meaningful change according to the patient's perception	The Minimal Clinically Important Improvement (MCII) will be assessed on the basis of the answers to the WOMAC questionnaire.	Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Secondary	Assessment of the highest level of symptom beyond which patients consider themselves well.	The Patient Acceptable Symptom State (PASS) will be assessed on the basis of the answers to the WOMAC questionnaire.	Month 1, Month 3 and Month 6 (D0-Month 1; Day 0-Month 3; Day 0-Month 6)
Secondary	Rescue medication	Consumption of level 1 and 2 painkillers, NSAIDs and corticosteroids	Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)