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

Phase 2

• Conditions: Osteoarthritis, Knee
• Interventions: Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)

• Registration Number: NCT04612023
• Lead Sponsor: Illinois Center for Orthopaedic Research and Education

Brief Summary

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.

Detailed Description

It is a prospective, double blinded, Randomized Controlled Trial study. Data will be prospectively collected of all injectable acellular amniotic membrane derived allograft knee performed at our institute (1 vs 2 mL).

90 subjects will be enrolled in the study. Subjects will be randomized 1:1:1 in treatment arms.

It compares the dose affect of an amniotic membrane allograft between a 1 mL dose and a 2 mL dose when compared to a placebo of sterile saline in the treatment of osteoarthritis of the knee. This will be offered as a free pain management alternative to patients who meet the inclusion criteria. The results will be determined by validated patient-reported outcome tools (KOOS, VAS, and WOMAC questionnaires) and physical examinations taken before the injection, one month after the injection, three months after the injection, six months after the injection, and one year after the injection. There will be a phone call 24 hours after the injection for every patient participating in the study regarding any potential adverse events.

Study Timeline

• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-10-27
• Study First Posted: 2020-11-02
• Study Start: 2020-11-18
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-10
• Last Update Posted: 2021-02-15
• Primary Completion: 2022-04-02
• Study Completion: 2022-07-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 mL NyDYN Injection	Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)	30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection.
2 mL NuDYN Injection	Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)	30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection.
Placebo of Sterile Saline	Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)	30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline.

Primary Outcome Measures

Name	Time	Method
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires	1 year	Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

Secondary Outcome Measures

Name	Time	Method
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires	30, 90, 180, 365 days	Change from baseline Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

Trial Locations

Locations (1)

ICORE; 🇺🇸 Westmont, Illinois, United States