A Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) Vs. Sterile Amniotic Fluid for Osteoarthritis

Who is this study for? Patients with osteoarthritis
What treatments are being studied? Amniotic Fluid Injection
Status: Completed
Location: See location...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY

This is a Phase I/II Randomized Double-Blinded Standard of Care (Corticosteroid) vs. Sterile Amniotic Fluid for Osteoarthritis

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Patients who are between the ages of 18-70 years

• A confirmed diagnosis of knee osteoarthritis based on clinical and radiographic findings consistent with Kellgren-Lawrence Stage 2-3 disease

• Patients who have failed conservative treatment (e.g. steroid, activity modification, therapy, etc.) within 3 months

• Unilateral or bilateral chronic knee joint pain \>4 months

• Patients who are able to ambulate (i.e. not wheelchair bound)

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

• Patients who are of childbearing potential must agree to use adequate contraception for 90 days after study drug injection

Locations
United States
Utah
University of Utah Orthopedic Center
Salt Lake City
Time Frame
Start Date: 2021-07-08
Completion Date: 2025-01-31
Participants
Target number of participants: 60
Treatments
Experimental: Amniotic Fluid Injection
Amniotic Fluid Injection, 3ml, one time dose.
Active_comparator: Standard of Care Steroid Injection
Corticosteroids, 3ml, one time dose.
Related Therapeutic Areas
Sponsors
Leads: University of Utah

This content was sourced from clinicaltrials.gov

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