Randomized Phase 2 Study of Platelet Rich Plasma Injections for Knee Osteoarthritis in Adults Aged 18 to 70 Exploring Protein Changes and Treatment Effects in Younger and Older Patients

What this Trial Is About

Researchers are evaluating the effects of platelet-rich plasma PRP injections on patients with knee osteoarthritis, focusing on how proteins in the blood change after treatment. This randomized, double-blind, placebo-controlled phase 2 trial includes a secondary crossover phase to ensure all participants receive at least one PRP injection. The study compares the protein changes caused by a single 5 mL PRP injection versus a saline placebo in two age groups 18-45 years and 46-70 years. Participants will be randomly assigned to receive either a PRP injection or a normal saline injection as a control. The PRP is prepared from 50 mL of the participants blood using a centrifuge, producing about 6 mL of PRP, of which 5 mL is injected into the knee. The study includes a crossover option at week 12 for participants initially receiving placebo to receive a PRP injection. The treatment phase lasts up to 26 weeks, with injections administered under blinded conditions to both participants and investigators. During the study, participants will undergo several in-person visits at baseline, weeks 2, 12, and for some, week 14, with additional remote visits at weeks 26, 52, and 104. Assessments include blood and synovial fluid collections, questionnaires, functional tests such as walking, sitting, standing, and stair climbing, and use of an activity monitor. Participants may also engage in physical therapy. Researchers will measure protein changes in blood samples at 2 and 12 weeks, and monitor symptoms and medication use via diaries. The primary outcome is the identification of protein changes two weeks after PRP injection.

Platelet Rich Plasma Injections In Young And Old Human Subjects