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

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03074526
• Other study ID #: OFORT003
• Status: Completed
• Phase: N/A
• Start date: January 23, 2017
• Est. completion date: April 25, 2018

Study information

• Verified date: November 2020
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: April 25, 2018
• Est. primary completion date: April 25, 2018
• 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.

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.

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Amniotic Fluid
Amniotic Fluid
• Saline Placebo
Saline Placebo

Locations

Country	Name	City	State
United States	Southeastern Center for Clinical Trials	Atlanta	Georgia
United States	Central Research Associates, Inc	Birmingham	Alabama
United States	Weil Foot, Ankle and Orthopedic Institute	Des Plaines	Illinois
United States	Hinsdale Orthopaedic Associates	Hinsdale	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	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	Range of Motion	subjects who experience a level of improvement in function as assessed by range of motion at 3 months	3 months
Secondary	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
Secondary	SF-12 Health Health Survey	patient-reported survey assessing patient health	4weeks, 6weeks, 3 months, 16 weeks, 6 months
Secondary	Activity of Daily Living Questionnaire	Changes in the subject's physical activity level	4weeks, 6weeks, 3 months, 16 weeks, 6 months