Recruiting

A-CP HA Kit vs. Hyaluronic Acid

Sponsor:

Regen Lab SA

Code:

NCT03201614

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

A-CP HA Kit

ArthroVisc 40

Placebo

Study Details

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.

Conditions

Knee Osteoarthritis

Study ID

NCT03201614

Start date

May 22, 2018

Status verified date

Dec, 2020

Completion date

Apr, 2022

Anticipated

Primary completion date

Apr, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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 3 on the 0-10-point WOMAC A subscale
  • Bilateral osteoarthritis provided that the contralateral knee has a pain no more than 2 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 2 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

Study Design

Enrollment

290 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

placebo comparator: Placebo

Patients randomized in this group will be treated with a saline solution.

Interventions

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

ArthroVisc 40

Patients randomized in this group will receive two injections of hyaluronic acid only (ArthroVisc 40) at Day 0 and Month 2

Placebo

Patients randomized in this group will receive two injections of a saline placebo at Day 0 and Month 2

Primary outcome measure

  • Variation in overall OA-related symptoms [ Time Frame: 6 Months ]
  • Variation in pain at walking (WOMAC A1 score) [ Time Frame: 6 Months ]

Central Contacts and Locations

Central contacts

Valerie De Fourmestraux, PhD

+41(0)21 864 01 18vdefourmestraux@regenlab.com

Locations

Bert Mandelbaum, MD

Recruiting

Santa Monica, California, United States, 90404

More Information

Sponsor

Regen Lab SA

Last update posted

Dec 21, 2020

Last verified

Dec, 2020

Keywords

  • platelet-rich plasma, hyaluronic acid, knee osteroarthritis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Regen Lab SA on 2020-12-21.