Evaluation of Amniotic Fluid Product in Knee Osteoarthritis

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

Official Title
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Protocol for the Clinical Evaluation Amniotic Fluid (AF) Product in Knee Osteoarthritis

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Other: Amniotic Fluid 4.0ml dose
* Other: Amniotic Fluid 2.0ml dose
* Other: Placebo Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AF 4.0<br>Amniotic Fluid 4.0ml dose | Other: Amniotic Fluid 4.0ml dose<br>* Injection of Amniotic Fluid<br>|
| Experimental: AF 2.0<br>Amniotic Fluid 2.0ml dose | Other: Amniotic Fluid 2.0ml dose<br>* Injection of Amniotic Fluid<br>|
| Placebo Comparator: Placebo<br>Saline Placebo Control | Other: Placebo Control<br>* Normal Saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Pain |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion |  | 3 month | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) |  | 3 month | 
| WOMAC |  | 3 month | 
| Kellgren-Lawrence grade of OA |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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OA, Osteoarthritis, Knee