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

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Regen Matrix-PRP-XLHA
Hylan G-F 20
Placebo
Sponsored by
RegenLab France SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis focused on measuring platelet-rich plasma, cross-linked hyaluronic acid, knee osteoarthritis

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital Le Bocage ChruRecruiting
  • Hopital LapeyronieRecruiting
  • Clinique Medipole Garonne, Radiologie Interventionnelle 45 Rue GironisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

RegenMatrix-PRP-XLHA

Hylan G-F 20

Placebo

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
Variation of joint function during daily activity
It will be assessed by the mean difference in the WOMAC C score overtime
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)
Variation of patient's quality of life
It will be assessed by the SF-12 questionnaire
Pain, function, patient's general assessment
It will be assessed by the% of OMERACT-OARSI responders
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.
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.
Rescue medication
Consumption of level 1 and 2 painkillers, NSAIDs and corticosteroids

Full Information

First Posted
January 9, 2023
Last Updated
August 23, 2023
Sponsor
RegenLab France SAS
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1. Study Identification

Unique Protocol Identification Number
NCT05727371
Brief Title
Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2023 (Actual)
Primary Completion Date
February 21, 2025 (Anticipated)
Study Completion Date
August 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RegenLab France SAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
platelet-rich plasma, cross-linked hyaluronic acid, knee osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RegenMatrix-PRP-XLHA
Arm Type
Experimental
Arm Description
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.
Arm Title
Hylan G-F 20
Arm Type
Active Comparator
Arm Description
Patients randomized in this group will receive a single injection of cross-linked hyaluronic acid Hylan G-F 20 (Synvisc-One®).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients randomized in this group will receive a single injection of saline solution (0.9% NaCl)
Intervention Type
Combination Product
Intervention Name(s)
Regen Matrix-PRP-XLHA
Intervention Description
Single intra-articular injection at Day 0
Intervention Type
Device
Intervention Name(s)
Hylan G-F 20
Intervention Description
Single intra-articular injection at Day 0
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single intra-articular injection at Day 0
Primary Outcome Measure Information:
Title
Variation in the osteoarthritis related pain
Description
It will be assessed by the mean difference in the WOMAC A score on a 100-mm VAS overtime
Time Frame
6 months (Day 0 - Month 6)
Secondary Outcome Measure Information:
Title
Variation in the overall osteoarthritis related pain
Description
It will be assessed by the mean difference in the WOMAC A score on a 100-mm VAS overtime
Time Frame
M1 and M3 (Day 0-Month 1; Day 0 - Month 3)
Title
Variation of joint stiffness after the first awakening and later in the day
Description
It will be assessed by the mean difference in the WOMAC B score overtime
Time Frame
Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Title
Variation of joint function during daily activity
Description
It will be assessed by the mean difference in the WOMAC C score overtime
Time Frame
Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Title
Variation in the osteoarthritis related symptoms
Description
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)
Time Frame
Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Title
Variation of patient's quality of life
Description
It will be assessed by the SF-12 questionnaire
Time Frame
Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Title
Pain, function, patient's general assessment
Description
It will be assessed by the% of OMERACT-OARSI responders
Time Frame
Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Title
Assessment of the minimal meaningful change according to the patient's perception
Description
The Minimal Clinically Important Improvement (MCII) will be assessed on the basis of the answers to the WOMAC questionnaire.
Time Frame
Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)
Title
Assessment of the highest level of symptom beyond which patients consider themselves well.
Description
The Patient Acceptable Symptom State (PASS) will be assessed on the basis of the answers to the WOMAC questionnaire.
Time Frame
Month 1, Month 3 and Month 6 (D0-Month 1; Day 0-Month 3; Day 0-Month 6)
Title
Rescue medication
Description
Consumption of level 1 and 2 painkillers, NSAIDs and corticosteroids
Time Frame
Month 1, Month 3 and Month 6 (Day 0-Month 1; Day 0-Month 3; Day 0-Month 6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno Boezennec, MD
Phone
+33 (0) 642 93 92 00
Email
bboezennec@regenlab.com
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Laperchia, PhD
Phone
+41 (0)21 864 03 52
Email
claperchia@regenlab.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Ornetti, MD
Organizational Affiliation
Centre Hospitalier Universitaire Dijon
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital Le Bocage Chru
City
Dijon
State/Province
DE
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valerie Orsini
Phone
03 80 29 58 85
Email
valerie.orsini@chu-dijon.fr
First Name & Middle Initial & Last Name & Degree
Paul ORNETTI, Pr.
Facility Name
Hopital Lapeyronie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odile Sechoy Balussou
Phone
04 67 35 51 91
Email
contrat-externe@chu-montpellier.fr
First Name & Middle Initial & Last Name & Degree
Yves-Marie PERS, Dr
Facility Name
Clinique Medipole Garonne, Radiologie Interventionnelle 45 Rue Gironis
City
Toulouse
ZIP/Postal Code
31100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Culine
Phone
06 28 93 57 27
Email
l.culine@medipole.com
First Name & Middle Initial & Last Name & Degree
Philippe Adam, Dr.

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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