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Comparative Evaluation of A-CP HA Kit, Hyaluronic Acid and Placebo for the Treatment of Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT03201614
Recruitment Status : Recruiting
First Posted : June 28, 2017
Last Update Posted : September 17, 2019
Sponsor:
Information provided by (Responsible Party):
Regen Lab SA

Brief Summary:

Hyaluronic acid (HA) is a major component of synovial fluid, to which it confers viscosity and elasticity. It has been shown that the rheological properties of the synovial fluid decrease in patients with osteoarthritis. Intra-articular injections of hyaluronic acid represents a commonly used therapeutic option to relieve osteoarthritic symptoms, by exerting a mechanical action on cartilaginous structures of the joints, thus leading to reduced pain and improved joint function.

Platelet-rich Plasma is an autologous product prepared from the patient's own blood. Potential benefits of platelet-rich plasma for the treatment of cartilage defects have been suggested by many in vitro and animal studies. There are an increasing number of clinical studies assessing the benefits of platelet rich plasma in the treatment of osteoarthritis, showing that platelet rich plasma improves symptoms with no serious adverse events reported.

On the basis of the above, HA and platelet-rich plasma have the potential to provide added benefits in osteoarthritis symptoms when combined, in particular in patients who have had previous intra-articular HA treatment but who are still experiencing pain. Preliminary evidence to this effect was presented at the 2014 Annual Congress of the French Rheumatology Society by a group of French investigators. Renevier and Marc enrolled patients who had not experienced adequate symptom relief from previous intra-articular HA treatment and treated them with HA plus platelet-rich plasma prepared using A-CP HA Kit. Of the 71 patients treated, approximately 90% were classified as responders based on the OMERACT-OARSI criteria.

The A-CP HA Kit allows for the preparation of a homogenous solution of platelet-rich plasma and HA, intended to be injected intra-articularly for the treatment of pain in osteoarthritis. In patients who had previous intra-articular HA treatment but who are still experiencing pain, treatment with HA plus platelet rich plasma could provide a safe and reproducible option before surgery.


Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: A-CP HA Kit Device: ArthroVisc 40 Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Evaluation of the Performance and Safety of A-CP HA Kit, for the Preparation of a Combination of Platelet Rich Plasma and Hyaluronic Acid, Versus Hyaluronic Acid Alone and Placebo in Patients With Knee Osteoarthritis
Actual Study Start Date : May 22, 2018
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: A-CP HA
Patients randomized in this group will be treated with a combination of platelet-rich plasma plus hyaluronic acid prepared with A-CP HA Kit.
Device: A-CP HA Kit
Patients randomized in this group will receive two injections of platelet-rich plasma/hyaluronic acid prepared with the A-CP HA Kit at Day 0 and Month 2

Active Comparator: ArthroVisc 40
Patients randomized in this group will be treated with hyaluronic acid only (ArthroVisc 40); hyaluronic acid is the same as the one contained in the A-CP HA Kit.
Device: ArthroVisc 40
Patients randomized in this group will receive two injections of hyaluronic acid only (ArthroVisc 40) at Day 0 and Month 2

Placebo Comparator: Placebo
Patients randomized in this group will be treated with a saline solution.
Drug: Placebo
Patients randomized in this group will receive two injections of a saline placebo at Day 0 and Month 2




Primary Outcome Measures :
  1. Variation in overall OA-related symptoms [ Time Frame: 6 Months ]
    It will be assessed by the mean difference in total WOMAC score on a 100-mm VAS between baseline and Month 6

  2. Variation in pain at walking (WOMAC A1 score) [ Time Frame: 6 Months ]
    II t will be assessed by the mean difference on a 100-mm VAS between baseline (D0) and Month 6


Secondary Outcome Measures :
  1. Variation in overall OA-related symptoms, between baseline (D0) and Month 1 (D30), Month 2, Month 3, Month 4, and Month 12 [ Time Frame: 12 Months ]
    It will be assessed by the mean difference in total WOMAC score on a 100-mm VAS between baseline (D0) and Month 1, Month 2, Month 3, Month 4, and month 12.

  2. Variation in pain at walking (WOMAC A1 score), between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, and Month 12 [ Time Frame: 12 Months ]
    It will be assessed by the mean difference in WOMAC A1 score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, and Month 12

  3. Variation of general pain, between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12 [ Time Frame: 12 Months ]
    It will be assessed by the mean difference in total WOMAC A score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

  4. Variation of joint stiffness, between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12 [ Time Frame: 12 Months ]
    It will be assessed by the mean difference in total WOMAC B score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

  5. Variation of joint function, between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12 [ Time Frame: 12 Months ]
    It will be assessed by the mean difference in total WOMAC C score on a 100-mm VAS between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

  6. % of OMERACT-OARSI responders [ Time Frame: 12 Months ]
    It will be assessed at Month 1, Month 2, Mont 3, Month 4, Month 6, and Month 12

  7. Patient's global assessment on a 7-point scale [ Time Frame: 12 Months ]
    It will be assessed at Month 1, Month 2, Mont 3, Month 4, Month 6, and Month 12

  8. Patient's global assessment on a 7-point scale at Month 1 (D30), Month 2, Mont 3, Month 4, Month 6, and Month 12 Clinician's global assessment on a 7-point scale [ Time Frame: 12 Months ]
    It will be assessed at Month 1, Month 2, Mont 3, Month 4, Month 6, and Month 12

  9. Variation of the patient's quality of life [ Time Frame: 12 months ]
    It will be assessed by the variation in the SF-36 questionnaire, between baseline (D0) and Month 1 (Day 30), Month 2, Month 3, Month 4, Month 6 and Month 12

  10. Rescue medication [ Time Frame: 12 Months ]
    Comparison of the use of rescue medication between the three groups of treatment at baseline, Month 1, Month 2, Month 3, Month 4, Month 6 and Month 12



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Osteoarthritis grade 2-3 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°)
  • Knee Pain level of at least 5 on the 0-10-point WOMAC A subscale
  • Bilateral osteoarthritis provided that the contralateral knee has a pain no more than 3 on the 0-10 point scale, and not requiring systemic analgesic treatment except paracetamol until the maximum dose of 4g per day

Exclusion Criteria:

  • Grade <2 or >3 OA according to the Kellgren and Lawrence grading scale
  • Bilateral osteoarthritis provided that the contralateral knee has a pain more than 3 on the 0-10 point scale and requiring systemic analgesic treatment or paracetamol more than 4g per day
  • Viscosupplementation in the treatment site in the past 3 months
  • Corticosteroid injection in the treatment site in the previous 3 months
  • Systematic use of corticosteroid (except those that are inhaled) within 3 months
  • History of allergy to hyaluronic acid
  • Rheumatological disorders
  • Clinical evidence of local inflammation such as redness or heat of the joint
  • Current or medical history of autoimmune disease
  • Surgery or arthroscopy surgery in the affected knee in the past 3 months
  • Local infection in the affected knee
  • Hematologic or clotting disorders (thrombocytopenia) or blood coagulation (deficit-blood dyscrasia)
  • Anaemia (Haemoglobin < 10g/dl)
  • Platelet count below 150/mmc
  • Anticoagulant treatment
  • Viral disease (hepatitis, herpes, varicella, zona, etc.)
  • Renal failure or hemodialysis
  • Acute infection
  • Immunosuppressive states
  • Malignant disease
  • Recent fever (within previous 2 weeks) or serious disorders (liver disease, active gastroduodenal ulcer, digestive hemorrhage, etc.)
  • Pregnancy or breastfeeding or planning pregnancy during the course of the study
  • Immunosuppressants within the past 6 weeks or ongoing
  • Uncontrolled diabetes
  • Participation in another clinical study in the past 3 months
  • Ongoing participation in another OA clinical study
  • Fracture, skeletal dysplasia, congenital or acquired deformity that affects the knee
  • Hemoglobin A1C > 8% within 8 weeks prior to the study treatment
  • Have been given the diagnosis of fibromyalagia, neuropathic pain syndrome, or depression
  • Refusal to sign or inability to give Informed Consent
  • Inability to understand or comply with the requirements of the study
  • Any other reason which may interfere with the proper conduct of the study, in the investigator's opinion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201614


Contacts
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Contact: Sheryl Berkowitz 347-744-1255 sberkowitz@regenlab.com

Locations
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United States, California
Bert Mandelbaum, MD Recruiting
Santa Monica, California, United States, 90404
Sponsors and Collaborators
Regen Lab SA
Investigators
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Principal Investigator: Bert Mandelbaum, MD Santa Monica Orthopaedic & Sports Medicine Group
Principal Investigator: Nicholas Sgaglione, MD Northwell Health
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Responsible Party: Regen Lab SA
ClinicalTrials.gov Identifier: NCT03201614    
Other Study ID Numbers: RL 04
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Regen Lab SA:
platelet-rich plasma, hyaluronic acid, knee osteroarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases