Evaluation of Amniotic Fluid Product in Knee Osteoarthritis

MiMedx

Status: Completed

Conditions: Osteoarthritis of the Knee

Treatments: Other: Amniotic Fluid 2.0ml dose; Other: Amniotic Fluid 4.0ml dose; Other: Placebo Control

Study type: Interventional

Funder types: Industry

Identifiers

NCT02768155

OFORT001

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

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.

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 3 months 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 3 months prior to screening.
6. 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.
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 Syndrome (AIDS) or HIV
12. Subject has had prior radiation at the site
13. Subject is currently taking anticoagulant therapy (excluding Plavix or Aspirin)
14. Diagnosis of gout in the past 6 month
15. Subject has a diagnosis of osteoarthritis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 3 patient groups, including a placebo group

AF 4.0

Experimental group

Description:

Amniotic Fluid 4.0ml dose

Treatment:

Other: Amniotic Fluid 4.0ml dose

AF 2.0

Experimental group

Description:

Amniotic Fluid 2.0ml dose

Treatment:

Other: Amniotic Fluid 2.0ml dose

Placebo

Placebo Comparator group

Description:

Saline Placebo Control

Treatment:

Other: Placebo Control