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

Study Overview
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Brief Summary
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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.

Detailed Description
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Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x). The estimated enrollment period is 6 months. Each subject will receive 1 injection and be evaluated for efficacy and safety during a 6 month observation period. The study is expected to be completed within 12 months, inclusive of enrollment and follow-up for all subjects.

Official Title
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Prospective, Double Blinded Randomized Multi-Center Controlled Trial Evaluating the 2 Different Doses of Lyophilized Amniotic Fluid Compared to a Saline Placebo Injection in the Treatment of Subjects With Osteoarthritic (OA) Knee Pain

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Other: Amniotic Fluid
* Other: Saline Placebo


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

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
Interventional Model Description: Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x).
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4mL amniotic fluid<br>Amniotic Fluid: 4mL dose of amniotic fluid | Other: Amniotic Fluid<br>* Amniotic Fluid<br>|
| Active Comparator: 4mL2x amniotic fluid<br>Amniotic Fluid: 4mL 2x dose of amniotic fluid | Other: Amniotic Fluid<br>* Amniotic Fluid<br>|
| Placebo Comparator: 4mL Saline Placebo<br>Normal Saline | Other: Saline Placebo<br>* Saline Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in Pain | The proportion of subjects who experience at least 20% improvement over baseline in Visual Analog Scale for Pain at 3 months in the Lyophilized amniotic fluid Injectable versus placebo-treated group. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of Motion | subjects who experience a level of improvement in function as assessed by range of motion at 3 months | 3 months | 
| Knee Injury and Osteoarthritis Outcome Score | measurement to assess the patient's opinion about their knee and associated problems by looking at pain, functions of daily living, function in sports and recreation, knee related quality of life and other symptoms | 4weeks, 6weeks, 3 months, 16 weeks, 6 months | 
| SF-12 Health Health Survey | patient-reported survey assessing patient health | 4weeks, 6weeks, 3 months, 16 weeks, 6 months | 
| Activity of Daily Living Questionnaire | Changes in the subject's physical activity level | 4weeks, 6weeks, 3 months, 16 weeks, 6 months |