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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

Primary Purpose

Osteoarthritis, Knee

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring osteoarthritis, amniotic fluid, amniotic allograft, knee, amniotic membrane

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

ICORERecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1 mL NyDYN Injection

2 mL NuDYN Injection

Placebo of Sterile Saline

Arm Description

30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection.

30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection.

30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline.

Outcomes

Primary Outcome Measures

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.

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).

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.

Secondary Outcome Measures

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.

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).

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.

Full Information

NCT ID

NCT04612023

First Posted

October 27, 2020

Last Updated

February 10, 2021

Sponsor

Illinois Center for Orthopaedic Research and Education

1. Study Identification

Unique Protocol Identification Number

NCT04612023

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2021

Overall Recruitment Status

Unknown status

Study Start Date

November 18, 2020 (Actual)

Primary Completion Date

April 2, 2022 (Anticipated)

Study Completion Date

July 2, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Illinois Center for Orthopaedic Research and Education

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

Keywords

osteoarthritis, amniotic fluid, amniotic allograft, knee, amniotic membrane

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

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.

Masking

ParticipantCare ProviderInvestigator

Masking Description

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.

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1 mL NyDYN Injection

Arm Type

Active Comparator

Arm Description

30 patients (out of 90) will be blind to and randomly assigned to a 1 mL NyDYN injection.

Arm Title

2 mL NuDYN Injection

Arm Type

Active Comparator

Arm Description

30 patients (out of 90) will be blind to and randomly assigned to a 2 mL NyDYN injection.

Arm Title

Placebo of Sterile Saline

Arm Type

Placebo Comparator

Arm Description

30 patients (out of 90) will be blind to and randomly assigned to a 2 mL dose of sterile saline.

Intervention Type

Other

Intervention Name(s)

Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)

Intervention Description

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).

Primary Outcome Measure Information:

Title

Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires

Description

Time Frame

1 year

Title

Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires

Description

Time Frame

1 year

Title

Primary Efficacy Endpoints using Validated patient-reported outcome tools questionnaires

Description

Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

Description

Time Frame

30, 90, 180, 365 days

Title

Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

Description

Time Frame

30, 90, 180, 365 days

Title

Exploratory Endpoint using Validated patient-reported outcome tools questionnaires

Description

Change from baseline Visual Analogue Scale (VAS)- assess pain, It is a 0-100 scale. A higher score indicates greater pain intensity.

Time Frame

30, 90, 180, 365 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eyal Ginesin, MD

Phone

6309292249

eginesin@ibji.com

First Name & Middle Initial & Last Name or Official Title & Degree

Ronak M Patel, MD

Phone

6309292249

rpatel@ibji.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nikil Chari

Organizational Affiliation

Research Assistant

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Jacob Barnhart

Organizational Affiliation

Research Assistant

Official's Role

Study Chair

Facility Information:

Facility Name

ICORE

City

Westmont

State/Province

Illinois

ZIP/Postal Code

60559

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ronak M Patel, MD

Phone

630-929-2249

rpatel@ibji.com

First Name & Middle Initial & Last Name & Degree

Eyal Ginesin, MD

Phone

6309292249

eginesin@ibji.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

26585668

Citation

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.

Results Reference

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PubMed Identifier

26683979

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.

Results Reference

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Learn more about this trial

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

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