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Organogenesis Knee OA

Title A Phase 3 Prospective, Multicenter, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Amniotic Suspension Allograft (ASA) in Patients with Osteoarthritis of the Knee
Therapeutic Area Osteoarthritis
Principal Investigator Steven Vlad
Min Age 18 Years
Gender All
Contact Sarah Pilgrim
617-636-5727
arthritisresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04636229

Overview

The purpose of this clinical research study is to learn more about the use of the study drug, amnion suspension allograft (written as ‘ASA’ in this form), for the potential treatment of osteoarthritis (OA) of the knee. The ASA injection is being studied to see if it improves the knee pain and function in people with knee OA

Study Details

Inclusion Criteria

  • Knee pain due to knee osteoarthritis
  • Failed to adequately respond to at least 2 osteoarthritis therapies

Exclusion Criteria

  • Corticosteroid injection within last three 3 months
  • Knee surgery within last 12 months
  • Acute knee trauma within last 3 months

Study Requirements

This study involves up to 13 visits to Tufts Medical Center. Each visit will take approximately 1 – 3 hours to complete. During the study, there will be 6 blood draws and about 148 ml (10 tablespoons) of blood will be collected. You will be asked to fill out questionnaires, complete two X-rays, and have physical examinations.