Hyaluronic Acid/Platelet-Rich Plasma Study

Condition: Osteoarthritis

Eligibility

Key Inclusion Criteria

  • Between 50-80 years old
  • Osteoarthritis grade 2-3 according to the Kellgren and Lawrence grading scale
  • Knee pain level of at least 5 on the 0-10-point WOMAC A subscale

Key Exclusion Criteria

  • OA Grade less than 2 or greater than 3 according to the Kellgren and Lawrence grading scale
  • Bilateral osteoarthritis provided that the less affected knee has a pain more than 3 on the 0-10-point scale
  • Corticosteroid injection in the treatment site within the past 3 months

Full Study Name

Comparative Evaluation of the Performance and Safety of A-CP HA Kit for the Reparation of a Combination of Platelet-Rich Plasma and Hyaluronic Acid, Versus Hyaluronic Acid alone and Placebo in Patients with Knee Osteoarthritis (IRB no. 44497)

Summary

This study focuses on individuals between 50 and 80 years old who suffer from moderate osteoarthritis (OA) in the knee, have at least moderate knee pain level, and have only slight osteoarthritis in the less severe arthritic knee. The purpose of the study is to determine whether an experimental treatment based on the combination of autologous platelet rich plasma (use of one's own blood) and hyaluronic acid (HA- a major component of synovial fluid in the knee), when using the A-CP HA kit injected into the knee, might improve the patient's osteoarthritis-related symptoms and reduce pain better than HA alone or a placebo (inactive substance).


Principal Investigator

Bert Mandelbaum, MD

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