Evaluation of Amniotic Fluid Product in Knee Osteoarthritis
NCT ID: NCT02768155
Last Updated: 2017-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2016-04-30
2017-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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AF 4.0
Amniotic Fluid 4.0ml dose
Amniotic Fluid 4.0ml dose
Injection of Amniotic Fluid
AF 2.0
Amniotic Fluid 2.0ml dose
Amniotic Fluid 2.0ml dose
Injection of Amniotic Fluid
Placebo
Saline Placebo Control
Placebo Control
Normal Saline
Interventions
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Amniotic Fluid 4.0ml dose
Injection of Amniotic Fluid
Amniotic Fluid 2.0ml dose
Injection of Amniotic Fluid
Placebo Control
Normal Saline
Eligibility Criteria
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Inclusion Criteria
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
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
30 Years
ALL
No
Sponsors
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MiMedx Group, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Donald Fetterolf, MD
Role: STUDY_DIRECTOR
MiMedx Group, Inc.
Locations
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Central Research Associates, Inc
Birmingham, Alabama, United States
Weil Foot, Ankle and Orthopedic Institute
Des Plaines, Illinois, United States
Countries
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Other Identifiers
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OFORT001
Identifier Type: -
Identifier Source: org_study_id