The ReNu Study

Condition: Osteoarthritis

Eligibility

Key Inclusion Criteria

  • Patients with moderate knee osteoarthritis 
  • Radiographic findings consistent with osteoarthritis as documented by Kellgren-Lawrence radiographic classification (Grade 2 or 3) 
  • At least 18 years old

Key Exclusion Criteria

  • Pain medication (including aspirin and ibuprofen) less than 15 days before injection
  • Receiving pain medication other than acetaminophen for conditions unrelated to osteoarthritis of the index knee
  • Regular use of anticoagulants

Full Study Name

An Investigation of ReNu Knee Injection: Monitoring the Response of Knee Function and Pain in Patients With Osteoarthritis (IRB no. 44402)

Summary

This study focuses on patients with moderate osteoarthritis. The purpose of the study is to evaluate the safety and effectiveness of the ReNu injection. ReNu is a human tissue allograft (tissue transplanted from one person to another) composed of amniotic fluid cells and amniotic membrane, both from the same donor. The treatment attempts to improve the internal environment of the arthritic knee with the goal of reducing pain and improving function.

Researchers will compare the effects of ReNu or Monovisc injection against the effects of a placebo (inactive substance) on moderate osteoarthritis. Participants will be randomly assigned to receive ReNu, Monovisc or placebo. ReNu is registered for clinical use with the U.S. Food and Drug Administration (FDA), but it has not been approved by the FDA. Monovisc injection is approved by the FDA to treat pain in osteoarthritis of the knee.

Phase
Phase IV


Principal Investigator

Bert Mandelbaum, MD

Contact