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

A Prospective, Double-Blinded, Randomized Controlled Trial of an Amniotic Membrane Allograft Injection Comparing Two Doses (1 mL and 2mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the Knee

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.

Study Overview

• Status: Unknown
• Conditions: Osteoarthritis, Knee
• Intervention / Treatment: Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)

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 Type: Interventional
• Enrollment (Anticipated): 90
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Eyal Ginesin, MD; Phone Number: 6309292249; Email: eginesin@ibji.com
• Study Contact Backup: Name: Ronak M Patel, MD; Phone Number: 6309292249; Email: rpatel@ibji.com

Study Locations

• United States
  • Illinois
    • Westmont, Illinois, United States, 60559
      • Recruiting
      • ICORE
      • Contact: Eyal Ginesin, MD; Phone Number: 6309292249; Email: eginesin@ibji.com
      • Contact: Ronak M Patel, MD; Phone Number: 630-929-2249; Email: rpatel@ibji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: 1 mL NyDYN Injection; 30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection.	Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN); Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).
ACTIVE_COMPARATOR: 2 mL NuDYN Injection; 30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection.	Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN); Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).
PLACEBO_COMPARATOR: Placebo of Sterile Saline; 30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline.	Other: Acellular Amniotic Membrane Derived Allograft Injection (NuDYN); Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires	Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	1 year
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).	1 year
Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires	Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires	Change from baseline Knee injury and Osteoarthritis Outcome Score (KOOS)- assess five outcomes: pain, symptoms, activities of daily living, sport and recreation function, and knee-related quality of life. It is a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.	30, 90, 180, 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires	Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)- assess the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints. it is a 0 (worst)-96 scale (best).	30, 90, 180, 365 days
Exploratory Endpoint using Validated patient-reported outcome tools questionnaires	Change from baseline Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.	30, 90, 180, 365 days

Collaborators and Investigators

• Sponsor: Illinois Center for Orthopaedic Research and Education
• Investigators: Study Chair: Nikil Chari, Research Assistant; Study Chair: Jacob Barnhart, Research Assistant

Publications and helpful links

General Publications

• Riboh JC, Saltzman BM, Yanke AB, Cole BJ. Human Amniotic Membrane-Derived Products in Sports Medicine: Basic Science, Early Results, and Potential Clinical Applications. Am J Sports Med. 2016 Sep;44(9):2425-34. doi: 10.1177/0363546515612750. Epub 2015 Nov 19.
• Vines JB, Aliprantis AO, Gomoll AH, Farr J. Cryopreserved Amniotic Suspension for the Treatment of Knee Osteoarthritis. J Knee Surg. 2016 Aug;29(6):443-50. doi: 10.1055/s-0035-1569481. Epub 2015 Dec 18.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 18, 2020
• Primary Completion (ANTICIPATED): April 2, 2022
• Study Completion (ANTICIPATED): July 2, 2022

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 27, 2020
• First Posted (ACTUAL): November 2, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 10, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: osteoarthritis; knee; amniotic membrane; amniotic fluid; amniotic allograft
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: 8212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No