PRP Injections for Osteoarthritis (PRP-KOBE Trial)

Palo Alto (17 mi)

Overseen byAnthony Luke, MD, MPH

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of California, San Francisco

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This is a randomized, double-blind, placebo-controlled phase 2 study with a secondary crossover phase at the end of the initial trial to ensure all subjects receive one PRP injection. The goal is to identify what proteins change in the blood following repeated intraarticular knee PRP injections in patients with knee osteoarthritis. The objective is to determine the protein changes resulting from a single autologous PRP injection (5 mL) in comparison to a normal saline control. About 60 subjects will take part in this study by two age groups at UCSF into the following arms: Arm A: PRP injection; Arm B: normal saline injection control. The study aims to demonstrate what benefits PRP has on knee osteoarthritis and methods to best achieve biologic effects. Subjects with a diagnosis of knee osteoarthritis ages 18-45 and 46-70 years old presenting to a University Based sports medicine clinic will be screened for potential eligibility. Subjects who meet all qualifying requirements will be recruited from UCSF's orthopedic and primary care clinics. Subjects will be on study for up to 26 weeks Screening: up to 14 days Treatment: injection of PRP or normal saline; subjects can cross over at week 12 to a PRP if originally in the control injection group Follow-up: 2 weeks post-baseline injection, 12 weeks postbaseline, (14 weeks if crossover patient), 26 weeks.

Eligibility Criteria

This trial is for individuals aged 18-70 with knee osteoarthritis, seeking treatment at a University Based sports medicine clinic. Participants will be divided into two age groups and must meet all qualifying requirements to join.

Inclusion Criteria

My knee has been graded between 1 to 3 for arthritis severity.

Exclusion Criteria

I have a condition that affects my blood's ability to clot.

I have had septic arthritis in the past.

I do not have any severe illnesses that prevent me from doing aerobic exercises.

I have had knee injection therapy for osteoarthritis in the last 6 months.

I have arthritis in other major joints of my legs that affects my daily activities.

I had knee surgery for arthritis or cartilage issues less than a year ago.

I have an autoimmune disorder, a weakened immune system, or a current or past cancer.

Treatment Details

The study tests the effects of Platelet-Rich Plasma (PRP) injections versus saline injections in treating knee osteoarthritis. It's randomized and double-blind, meaning neither the researchers nor participants know who gets PRP or placebo until after the study.

2Treatment groups

Experimental Treatment

Group I: Platelet-rich plasma (PRP)Experimental Treatment2 Interventions

A vacutainer vial containing 50 mL of peripheral blood will be processed immediately to create PRP using a previously optimized two-step centrifugation protocol viii. First, the whole blood will be centrifuged at 500 x g for 8 minutes at 4°C. The plasma will be collected above the buffy coat using a sterile pipette, placed into a separate sterile tube, and centrifuged a second time at 700 x g for 17 minutes at 12° C. The top 70% will be collected as the PPP and the bottom 30% will be resuspended as the PRP. PPP will be aliquoted into cryovials for storage at -80 °C. Approximately 6 mL of PRP will be produced from each 50 mL vial of whole blood. Five mL will be allocated for administration to patients and the remaining one mL will be aliquoted into cryovials for storage at -80 °C. The syringe containing PRP will be covered with Aluminum foil, such that the investigator cannot tell what fluid is to be injected.

Group II: Control saline injection (wait-list control)Experimental Treatment2 Interventions

A placebo injection of 6 mL of 0.9% saline will be prepared by the unblinded research assistant in an adjacent room. The syringed will be prepared in a 10 mL syringe and covered with Aluminum foil, such that the investigator performing the injection cannot tell if there is PRP or saline to be injected.