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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04612023
• Other study ID #: 8212
• Status: Recruiting
• Phase: Phase 2
• Start date: November 18, 2020
• Est. completion date: July 2, 2022

Study information

• Verified date: February 2021
• Source: Illinois Center for Orthopaedic Research and Education
• Contact: Eyal Ginesin, MD
• Phone: 6309292249
• Email: eginesin[@]ibji.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: July 2, 2022
• Est. primary completion date: April 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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).

Locations

Country	Name	City	State
United States	ICORE	Westmont	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Illinois Center for Orthopaedic Research and Education

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. Review. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	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	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
Secondary	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
Secondary	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