Evaluation of Amniotic Fluid Product in Knee Osteoarthritis

Osteoarthritis of the Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768155
• Other study ID #: OFORT001
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: October 25, 2017
• Start date: April 2016
• Est. completion date: July 2017

Study information

• Verified date: October 2017
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Other:
• Amniotic Fluid 4.0ml dose
Injection of Amniotic Fluid
• Amniotic Fluid 2.0ml dose
Injection of Amniotic Fluid
• Placebo Control
Normal Saline

Locations

Country	Name	City	State
United States	Central Research Associates, Inc	Birmingham	Alabama
United States	Weil Foot, Ankle and Orthopedic Institute	Des Plaines	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in Pain		3 months
Secondary	Range of Motion		3 month
Secondary	Knee injury and Osteoarthritis Outcome Score (KOOS)		3 month
Secondary	WOMAC		3 month
Secondary	Kellgren-Lawrence grade of OA		6 months