Principal Investigator: David Petron
Keywords: Phase I/II , Amniotic Fluid , Biologics , Osteoarthritis Department: Orthopedic Surgery Operations
IRB Number: 00128491
Specialty: Sports Medicine, Orthopaedic Surgery
Sub Specialties:
Recruitment Status: Not yet recruiting

Contact Information

Zach Olsen

Brief Summary

Primary Objectives:

  • To determine the safety of using processed Amniotic Fluid (pAF) in patients with osteoarthritis
  • To determine the need for repeat intra-articular injection

Secondary Objectives:

  • To determine the pain level following the injection of AF relative to corticosteroids
  • To evaluate functional outcomes

Inclusion Criteria

1. Age: 18-75 years of age (Adult)

2. Sexes: All

3. Confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings consistent with Kellgren-Lawrence stage 2-3 disease

4. Patient's who have failed conservative treatment (e.g. steroid, activity modification, therapy, etc.) within 3 months. 

5. Unilateral or bilateral chronic joint pain >4 months

6. Must be able to ambulate (not wheelchair bound)

7. Patient reported a typical pain of at least 4 out of 10 during the past week using VAS numeric pain scale (0-10)

Exclusion Criteria

1. Subjects who have had a previous injection (i.e. steroid, platelet rich plasma, or other) within the last 3 months

2. BMI >40 as defined by NIH Clinical Guidelines Body Mass Index

3. Concurrent participation in another investigational trial involving systemic administration of agents (within the previous 30 days) or plans to participate in any other allogeneic stem cell therapy trial during the 12 month follow-up period

4. Clinical suspicion of infection at injection site

5. Any surgeries within 4 weeks, other than diagnostic surgery

6. Insulin or self-reported non-insulin dependent diabetic evident of HgA1c ≥8% among known diabetics

7. Unable to consent to an English Language Consent Form

8. Frank mechanical issues (i.e. locking of the knee)

9. Workman’s Compensation cases

10. Rheumatoid arthritis

11. Patients with a known allergy to local anesthetics or components of the study drug (pAF or steroid injection

12. Patients with vascular claudication or neurologic disorders affecting the index lower limb

13. Patients with inflammatory arthropathies or connective tissue disorders

14. Patients with known  alcohol or drug abuse or dependence, recreational use of illicit drug or prescription medications, or have used medical marijuana within 7 days of study enrollment

15. Patients with history of active cancer/malignancy within 2 years of screening, apart from adequately treated basal cell or squamous cell carcinoma of the skin not associated with the target knee

16. Women who are nursing or pregnant

17. Patients of childbearing potential who are unwilling to use adequate contraception for 90 days after study drug injection