Overview

This trial is active, not recruiting.

Condition osteoarthritis of the knee
Treatments amniotic fluid 4.0ml dose, amniotic fluid 2.0ml dose, placebo control
Sponsor MiMedx Group, Inc.
Start date April 2016
End date April 2017
Trial size 60 participants
Trial identifier NCT02768155, OFORT001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Amniotic Fluid 4.0ml dose
amniotic fluid 4.0ml dose
Injection of Amniotic Fluid
(Experimental)
Amniotic Fluid 2.0ml dose
amniotic fluid 2.0ml dose
Injection of Amniotic Fluid
(Placebo Comparator)
Saline Placebo Control
placebo control
Normal Saline

Primary Outcomes

Measure
Reduction in Pain
time frame: 3 months

Secondary Outcomes

Measure
Range of Motion
time frame: 3 month
Knee injury and Osteoarthritis Outcome Score (KOOS)
time frame: 3 month
WOMAC
time frame: 3 month
Kellgren-Lawrence grade of OA
time frame: 12 months

Eligibility Criteria

Male or female participants at least 30 years old.

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

Additional Information

Official title Protocol for the Clinical Evaluation Amniotic Fluid (AF) Product in Knee Osteoarthritis
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by MiMedx Group, Inc..