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

NCT ID: NCT03074526

Last Updated: 2020-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-23

Study Completion Date

2018-04-25

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.

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Approximately 180 subjects will be enrolled in one of three dose arms ( 4ml, Saline Placebo and 4ml 2x).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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4mL amniotic fluid

Amniotic Fluid: 4mL dose of amniotic fluid

Group Type ACTIVE_COMPARATOR

Amniotic Fluid

Intervention Type OTHER

Amniotic Fluid

4mL2x amniotic fluid

Amniotic Fluid: 4mL 2x dose of amniotic fluid

Group Type ACTIVE_COMPARATOR

Amniotic Fluid

Intervention Type OTHER

Amniotic Fluid

4mL Saline Placebo

Normal Saline

Group Type PLACEBO_COMPARATOR

Saline Placebo

Intervention Type OTHER

Saline Placebo

Interventions

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Amniotic Fluid

Amniotic Fluid

Intervention Type OTHER

Saline Placebo

Saline Placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MiMedx Group, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Mason, MD

Role: STUDY_DIRECTOR

Chief Medical Officer

Locations

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Central Research Associates, Inc

Birmingham, Alabama, United States

Site Status

Southeastern Center for Clinical Trials

Atlanta, Georgia, United States

Site Status

Weil Foot, Ankle and Orthopedic Institute

Des Plaines, Illinois, United States

Site Status

Hinsdale Orthopaedic Associates

Hinsdale, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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OFORT003

Identifier Type: -

Identifier Source: org_study_id