A Study to Compare A-CP HA Kit, Hyaluronic Acid and Placebo To Treatment Knee Osteoarthritis

Overview

About this study

The purpose of this study is to determine if a treatment based on the combination of platelet rich plasma and HA obtained with the A-CP HA Kit is statistically superior to a saline placebo or HA alone in terms of Improvement of OA-related symptoms between baseline(D0) and Month 6, and reduction of pain at walking between baseline (D0) and Month 6.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Shane Shapiro, M.D.

Open for enrollment

Contact information:

Jennifer Arthurs APRN

(904) 956-3200

Arthurs.Jennifer@mayo.edu

More information

Publications

Publications are currently not available