Protocol for the Clinical Evaluation of Lyophilized Amniotic Fluid in the Treatment of Knee Osteoarthritis

Completed · Not applicable · Has a placebo group

Conditions studied: Osteoarthritis, Knee

In brief

To evaluate the efficacy of Lyophilized amniotic fluid as compared to the Saline Injection, placebo control in the treatment of moderate osteoarthritis of the knee.

Key facts

Study ID

NCT03074526

Run by

MiMedx Group, Inc.

People needed

156

Starts

2017-01-23

Expected to finish

2018-04-25

Last updated by the study team

2020-11-13

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

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.
• Subject must have a VAS pain scale greater than 30.

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 12 weeks prior to screening.
• Subject has received a steroid or platelet rich plasma (PRP) injection for the treatment of OA of the target knee within 12 weeks prior to screening.
• Subject has had major surgery 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 Syndromes (AIDS) or HIV
• Subject has had prior radiation at the site
• Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
• New diagnosis of gout in the past 6 month
• Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale.
• Subject has a diagnosis of Osteonecrosis of the knee.
• Subject has had a total knee replacement.

Where it is running

• Central Research Associates, Inc — Birmingham, Alabama, United States
• Southeastern Center for Clinical Trials — Atlanta, Georgia, United States
• Weil Foot, Ankle and Orthopedic Institute — Des Plaines, Illinois, United States
• Hinsdale Orthopaedic Associates — Hinsdale, Illinois, United States

Full record on ClinicalTrials.gov

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