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

Not Applicable

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Other: Saline Placebo; Other: Amniotic Fluid

• Registration Number: NCT03074526
• Lead Sponsor: MiMedx Group, Inc.

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-23
• Study First Submitted: 2017-01-27
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-08
• Primary Completion: 2018-04-25
• Study Completion: 2018-04-25
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 156

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

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 12 weeks 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 12 weeks prior to screening.
6. 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.
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 Syndromes (AIDS) or HIV
12. Subject has had prior radiation at the site
13. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
14. New diagnosis of gout in the past 6 month
15. Subject has a diagnosis of osteoarthritis (OA) defined as Grade 4 on the Kellgren Lawrence grading scale.
16. Subject has a diagnosis of Osteonecrosis of the knee.
17. Subject has had a total knee replacement.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4mL Saline Placebo	Saline Placebo	Normal Saline
4mL amniotic fluid	Amniotic Fluid	Amniotic Fluid: 4mL dose of amniotic fluid
4mL2x amniotic fluid	Amniotic Fluid	Amniotic Fluid: 4mL 2x dose of amniotic fluid

Primary Outcome Measures

Name	Time	Method
Reduction in Pain	3 month	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.

Secondary Outcome Measures

Name	Time	Method
Range of Motion	3 months	subjects who experience a level of improvement in function as assessed by range of motion at 3 months
Knee Injury and Osteoarthritis Outcome Score	4weeks, 6weeks, 3 months, 16 weeks, 6 months	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
SF-12 Health Health Survey	4weeks, 6weeks, 3 months, 16 weeks, 6 months	patient-reported survey assessing patient health
Activity of Daily Living Questionnaire	4weeks, 6weeks, 3 months, 16 weeks, 6 months	Changes in the subject's physical activity level

Trial Locations

Locations (4)

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