Back to results

Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Amniotic Fluid

Saline Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject is 30 years or older.
Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale.
Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study.
Subject must have a VAS pain scale greater than 30.

Exclusion Criteria:

Subject has active infection at the injection site.
Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain.
BMI greater than 45 kg/m2
Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
Subject has had major surgery or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment.
Subject is pregnant or plans to become pregnant within 180 days of treatment.
Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
Subject has a history of immunosuppressive or chemotherapy in the last 5 years
Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV
Subject has had prior radiation at the site
Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
New diagnosis of gout in the past 6 month
Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale.
Subject has a diagnosis of Osteonecrosis of the knee.
Subject has had a total knee replacement.

Sites / Locations

Central Research Associates, Inc
Southeastern Center for Clinical Trials
Weil Foot, Ankle and Orthopedic Institute
Hinsdale Orthopaedic Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

4mL amniotic fluid

4mL2x amniotic fluid

4mL Saline Placebo

Arm Description

Amniotic Fluid: 4mL dose of amniotic fluid

Amniotic Fluid: 4mL 2x dose of amniotic fluid

Normal Saline

Outcomes

Primary Outcome Measures

Reduction in Pain

The proportion of subjects who experience at least 20% improvement over baseline in Visual Analog Scale for Pain at 3 months in the Lyophilized amniotic fluid Injectable versus placebo-treated group.

Secondary Outcome Measures

Range of Motion

subjects who experience a level of improvement in function as assessed by range of motion at 3 months

Knee Injury and Osteoarthritis Outcome Score

measurement to assess the patient's opinion about their knee and associated problems by looking at pain, functions of daily living, function in sports and recreation, knee related quality of life and other symptoms

SF-12 Health Health Survey

patient-reported survey assessing patient health

Activity of Daily Living Questionnaire

Changes in the subject's physical activity level

Full Information

NCT ID

NCT03074526

First Posted

January 27, 2017

Last Updated

November 12, 2020

Sponsor

MiMedx Group, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03074526

Brief Title

Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis

Official Title

Prospective, Double Blinded Randomized Multi-Center Controlled Trial Evaluating the 2 Different Doses of Lyophilized Amniotic Fluid Compared to a Saline Placebo Injection in the Treatment of Subjects With Osteoarthritic (OA) Knee Pain

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

January 23, 2017 (Actual)

Primary Completion Date

April 25, 2018 (Actual)

Study Completion Date

April 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MiMedx Group, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

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

To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee.

Detailed Description

Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x). The estimated enrollment period is 6 months. Each subject will receive 1 injection and be evaluated for efficacy and safety during a 6 month observation period. The study is expected to be completed within 12 months, inclusive of enrollment and follow-up for all subjects.

6. Conditions and Keywords

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

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x).

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

156 (Actual)

8. Arms, Groups, and Interventions

Arm Title

4mL amniotic fluid

Arm Type

Active Comparator

Arm Description

Amniotic Fluid: 4mL dose of amniotic fluid

Arm Title

4mL2x amniotic fluid

Arm Type

Active Comparator

Arm Description

Amniotic Fluid: 4mL 2x dose of amniotic fluid

Arm Title

4mL Saline Placebo

Arm Type

Placebo Comparator

Arm Description

Normal Saline

Intervention Type

Other

Intervention Name(s)

Amniotic Fluid

Intervention Description

Amniotic Fluid

Intervention Type

Other

Intervention Name(s)

Saline Placebo

Intervention Description

Saline Placebo

Primary Outcome Measure Information:

Title

Reduction in Pain

Description

The proportion of subjects who experience at least 20% improvement over baseline in Visual Analog Scale for Pain at 3 months in the Lyophilized amniotic fluid Injectable versus placebo-treated group.

Time Frame

3 month

Secondary Outcome Measure Information:

Title

Range of Motion

Description

subjects who experience a level of improvement in function as assessed by range of motion at 3 months

Time Frame

3 months

Title

Knee Injury and Osteoarthritis Outcome Score

Description

Time Frame

4weeks, 6weeks, 3 months, 16 weeks, 6 months

Title

SF-12 Health Health Survey

Description

patient-reported survey assessing patient health

Time Frame

4weeks, 6weeks, 3 months, 16 weeks, 6 months

Title

Activity of Daily Living Questionnaire

Description

Changes in the subject's physical activity level

Time Frame

4weeks, 6weeks, 3 months, 16 weeks, 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject is 30 years or older. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 1 to 3 on the Kellgren Lawrence grading scale. Subject is willing and able provide informed consent and participate in all procedures and follow-up evaluations necessary to complete the study. Subject must have a VAS pain scale greater than 30. Exclusion Criteria: Subject has active infection at the injection site. Subject has rheumatoid arthritis, psoriatic arthritis, or have been diagnosed with any other auto-immune disorders that could be the cause of their knee pain. BMI greater than 45 kg/m2 Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 12 weeks prior to screening. Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 12 weeks prior to screening. Subject has had major surgery or arthroscopy in the target knee within 26 weeks of treatment or plans to have surgery in the target knee within 180 days of treatment. Subject is pregnant or plans to become pregnant within 180 days of treatment. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation. Subject has a history of immunosuppressive or chemotherapy in the last 5 years Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndromes (AIDS) or HIV Subject has had prior radiation at the site Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin) New diagnosis of gout in the past 6 month Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale. Subject has a diagnosis of Osteonecrosis of the knee. Subject has had a total knee replacement.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Mason, MD

Organizational Affiliation

Chief Medical Officer

Official's Role

Study Director

Facility Information:

Facility Name

Central Research Associates, Inc

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

Southeastern Center for Clinical Trials

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30033

Country

United States

Facility Name

Weil Foot, Ankle and Orthopedic Institute

City

Des Plaines

State/Province

Illinois

ZIP/Postal Code

60016

Country

United States

Facility Name

Hinsdale Orthopaedic Associates

City

Hinsdale

State/Province

Illinois

ZIP/Postal Code

60521

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis

We'll reach out to this number within 24 hrs