Evaluation of Amniotic Fluid Product in Knee Osteoarthritis

Protocol for the Clinical Evaluation Amniotic Fluid (AF) Product in Knee Osteoarthritis

A study evaluating Amniotic Fluid compared to a Saline Placebo Injection in the treatment of subjects with osteoarthritic (OA) knee pain

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Other: Amniotic Fluid 4.0ml dose; Other: Amniotic Fluid 2.0ml dose; Other: Placebo Control

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Central Research Associates, Inc
  • Illinois
    • Des Plaines, Illinois, United States, 60016
      • Weil Foot, Ankle and Orthopedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Subject has active infection at the injection site.
2. 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.
3. BMI greater than 45 kg/m2
4. Subject has received an intra-articular hyaluronic acid (HA) injection for the treatment of OA of the target knee within 3 months prior to screening.
5. Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 3 months prior to screening.
6. Subject has had major surgery, arthroplasty 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.
7. Subject is pregnant or plans to become pregnant within 180 days of treatment.
8. Subject has used an investigational drug, device or biologic within 12 weeks prior to treatment.
9. Subject has any significant medical condition that, in the opinion of the Investigator, would interfere with protocol evaluation and participation.
10. Subject has a history of immunosuppressive or chemotherapy in the last 5 years
11. Subject has autoimmune disease or a known history of having Acquired Immunodeficiency Syndrome (AIDS) or HIV
12. Subject has had prior radiation at the site
13. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
14. Diagnosis of gout in the past 6 month
15. Subject has a diagnosis of osteoarthritis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: AF 4.0; Amniotic Fluid 4.0ml dose	Other: Amniotic Fluid 4.0ml dose; Injection of Amniotic Fluid
Experimental: AF 2.0; Amniotic Fluid 2.0ml dose	Other: Amniotic Fluid 2.0ml dose; Injection of Amniotic Fluid
Placebo Comparator: Placebo; Saline Placebo Control	Other: Placebo Control; Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reduction in Pain	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Range of Motion	3 month
Knee injury and Osteoarthritis Outcome Score (KOOS)	3 month
WOMAC	3 month
Kellgren-Lawrence grade of OA	6 months

Collaborators and Investigators

• Sponsor: MiMedx Group, Inc.
• Investigators: Study Director: Donald Fetterolf, MD, MiMedx Group, Inc.

Study record dates

Study Major Dates

• Study Start: April 1, 2016
• Primary Completion (Actual): April 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: May 6, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 11, 2016

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 25, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: OA, Osteoarthritis, Knee
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: OFORT001

Plan for Individual participant data (IPD)

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