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Biological

PRP Injections for Osteoarthritis (PRP-KOBE Trial)

Phase 2

Waitlist Available

Led By Anthony Luke, MD, MPH

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Grade 1-3 KL score will be recruited

Be older than 18 years old

Must not have

Patient with platelet disorders, bleeding disorder

History of septic arthritis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks, 12 weeks and 26 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effects of platelet-rich plasma (PRP) injections on knee osteoarthritis. The study will involve 60 subjects in two age groups who will receive either a

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include pain at injection site, swelling, stiffness, or bleeding due to needle insertion. Since it uses patients' own blood for PRP, allergic reactions are less likely.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had septic arthritis in the past.

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

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

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks, 12 weeks and 26 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks, 12 weeks and 26 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks, 12 weeks and 26 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Identify Protein Changes in Platelet Rich Plasma (PRP)

Secondary study objectives

To determine the Intra-individual change in specific proteins in the peripheral blood

Other study objectives

Change in Visual Analog Pain Scores

Changes in Knee Injury and Osteoarthritis Outcome Scores (KOOS scores)

Examine Differences by Age

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 8Eligibility criteria met