Evaluation of Amniotic Fluid Product in Knee Osteoarthritis

NCT02768155 | Completed DMC

• 1 other identifier: OFORT001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Osteoarthritis of the Knee

Keywords

OA, Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Reduction in Pain

  3 months

Secondary Outcomes (4)

• Range of Motion

  3 month

• Knee injury and Osteoarthritis Outcome Score (KOOS)

  3 month

• WOMAC

  3 month

• Kellgren-Lawrence grade of OA

  6 months

Study Arms (3)

AF 4.0

EXPERIMENTAL

Amniotic Fluid 4.0ml dose

Other: Amniotic Fluid 4.0ml dose

AF 2.0

EXPERIMENTAL

Amniotic Fluid 2.0ml dose

Other: Amniotic Fluid 2.0ml dose

Placebo

PLACEBO COMPARATOR

Saline Placebo Control

Other: Placebo Control

Interventions

Amniotic Fluid 4.0ml dose OTHER

Injection of Amniotic Fluid

AF 4.0

Amniotic Fluid 2.0ml dose OTHER

Injection of Amniotic Fluid

AF 2.0

Placebo Control OTHER

Normal Saline

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 3 months prior to screening.
• 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.
• 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.
• 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 Syndrome (AIDS) or HIV
• Subject has had prior radiation at the site
• Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
• Diagnosis of gout in the past 6 month
• Subject has a diagnosis of osteoarthritis

Sponsors & Collaborators

• MiMedx Group, Inc.: lead

Study Sites (2)

Central Research Associates, Inc

Birmingham, Alabama, 35205, United States

Location

Weil Foot, Ankle and Orthopedic Institute

Des Plaines, Illinois, 60016, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Donald Fetterolf, MD

  MiMedx Group, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 11, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: July 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)