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

NCT04612023 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: 8212
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Keywords

osteoarthritis; amniotic fluid; amniotic allograft; knee; amniotic membrane

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

  30, 90, 180, 365 days

• Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

  30, 90, 180, 365 days

• Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

  30, 90, 180, 365 days

Study Arms (3)

1 mL NyDYN Injection

ACTIVE COMPARATOR

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)

2 mL NuDYN Injection

ACTIVE COMPARATOR

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)

Placebo of Sterile Saline

PLACEBO COMPARATOR

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)

Interventions

Acellular Amniotic Membrane Derived Allograft Injection (NuDYN) OTHER

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).

1 mL NyDYN Injection; 2 mL NuDYN Injection; Placebo of Sterile Saline

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Illinois Center for Orthopaedic Research and Education: lead

Study Sites (1)

ICORE

Westmont, Illinois, 60559, United States

RECRUITING

Related 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.

  PMID: 26585668 BACKGROUND

• 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.

  PMID: 26683979 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Nikil Chari

  Research Assistant

  STUDY CHAIR

• Jacob Barnhart

  Research Assistant

  STUDY CHAIR

Central Study Contacts

Eyal Ginesin, MD

CONTACT

6309292249; eginesin@ibji.com

Ronak M Patel, MD

CONTACT

6309292249; rpatel@ibji.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Assistants not part of the study used a randomizer generating software to randomly assign a patient a dose. The randomly assigned dose was put in a sealed envelope labeled with the corresponding number and was recorded. Prior to the injection, a medical assistant not involved in the study retrieves the envelope to determine the dose, prepares the injection, then seals the syringe in black tape before giving it to the research staff who then performs the injection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Surgeon / Fellow Researcher

Model Details: Data will be prospectively collected on all injectable acellular amniotic membrane derived allograft knee performed at our institute. (FDA regulated - HCT/P regulation) Inclusion criteria will be all patients age between 21 and 80 years with a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. Methods for collecting data will be through validated patient-reported outcome tools that the patient will complete pre-injection and at specified time intervals after injection: 30 days, 90 days, 180 days and 365 days. Patient will receive a phone call 24 hours after the injection to monitor any immediate potential adverse events.

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 2, 2020
• Study Start: November 18, 2020
• Primary Completion: April 2, 2022
• Study Completion: July 2, 2022
• Last Updated: February 15, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)