An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2 mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

The purpose of this study is to determine the dose effect of a single injectable acellular amniotic membrane derived allograft for the treatment of knee osteoarthritis and to confirm whether the use of 2 mL of the same amniotic injection offers a statistically significant advantage over the 1 mL injection when compared to a placebo.

Key facts

Study ID

NCT04612023

Run by

Illinois Center for Orthopaedic Research and Education

People needed

90

Starts

2020-11-18

Expected to finish

2022-07-02

Last updated by the study team

2021-02-15

Who can join

Age: 21 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patient is a candidate for non-surgical intervention of the knee
• Patient must be between the ages of 21 and 80 years old
• Patient must have a diagnosis of osteoarthritis (OA) of the knee defined as grade 1 to 3 on the Kellgren-Lawrence grading scale

You may not qualify if…

• Patient has a diagnosis of osteoarthritis with a Kellgren-Lawrence grade of 4
• Patient has a BMI greater than 40 kg/m2, active infection at the injection site, symptomatic OA of the contralateral knee or of either hip that is not responsive to acetaminophen (Tylenol) and requires other therapy
• Patient has rheumatoid arthritis, psoriatic arthritis or diagnosis with any other disorder that is the primary source of their knee pain
• Patient has an autoimmune disease or known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
• Patient has any of the following treatments to the target knee within 12 weeks prior to screening
• Intra-articular hyaluronic acid (HA) injection
• Steroid or platelet rich plasma (PRP) injection
• Use of any investigational drug, device, or biologic
• Patient had or is planning to have major surgery or arthroscopy in the target knee within 26 weeks of treatment
• Patient has a history of partial or total knee arthroplasty
• Patient has undergone immunotherapy or chemotherapy in the last 5 years, prior radiation at the site, or is currently taking a narcotic medication for any reason
• Patient is pregnant or plans to become pregnant within 365 days of treatment
• Patient has any significant medical condition that would interfere with protocol evaluation and participation
• Patient is a recipient of worker's compensation
• Patient is a current prisoner

Where it is running

• ICORE — Westmont, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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