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Evaluation of Amniotic Fluid Product in Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02768155
Recruitment Status : Completed
First Posted : May 11, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
MiMedx Group, Inc.

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

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Other: Amniotic Fluid 4.0ml dose Other: Amniotic Fluid 2.0ml dose Other: Placebo Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Protocol for the Clinical Evaluation Amniotic Fluid (AF) Product in Knee Osteoarthritis
Study Start Date : April 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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




Primary Outcome Measures :
  1. Reduction in Pain [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. Range of Motion [ Time Frame: 3 month ]
  2. Knee injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: 3 month ]
  3. WOMAC [ Time Frame: 3 month ]
  4. Kellgren-Lawrence grade of OA [ Time Frame: 6 months ]


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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02768155


Locations
United States, Alabama
Central Research Associates, Inc
Birmingham, Alabama, United States, 35205
United States, Illinois
Weil Foot, Ankle and Orthopedic Institute
Des Plaines, Illinois, United States, 60016
Sponsors and Collaborators
MiMedx Group, Inc.
Investigators
Study Director: Donald Fetterolf, MD MiMedx Group, Inc.

Responsible Party: MiMedx Group, Inc.
ClinicalTrials.gov Identifier: NCT02768155     History of Changes
Other Study ID Numbers: OFORT001
First Posted: May 11, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MiMedx Group, Inc.:
OA, Osteoarthritis, Knee

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases