Platelet-rich plasma injections for knee osteoarthritis in younger and older adults
Study of Platelet Rich Plasma (PRP) Injections With Symptomatic Knee Osteoarthritis for Biomarker Exploration in Young and Old Human Subjects
This trial will test whether a single 5 mL platelet-rich plasma (PRP) knee injection changes blood and joint protein markers compared with a saline injection in adults aged 18–70 with knee osteoarthritis.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | University of California, San Francisco Academic / other |
| Drugs / interventions | Chemotherapy, prednisone |
| Locations | 1 site (San Francisco, California) |
| Trial ID | NCT06451120 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled phase 2 trial at UCSF will compare a single 5 mL autologous PRP intraarticular knee injection to a normal saline control in about 60 adults stratified into two age cohorts (18–45 and 46–70). Participants will have baseline, week 2, and week 12 in-person visits for blood and synovial fluid biomarker sampling, an optional 14-week visit for some participants, and remote follow-ups through week 104. A secondary crossover at the end of the initial blinded period ensures all participants receive one PRP injection, and the first 20 sample batches will be unblinded for assay validation. The primary goal is to identify immediate and delayed protein changes in blood and synovial fluid to better understand PRP’s biological effects in degenerative knee disease.
Who should consider this trial
Good fit: Adults 18–70 years old with symptomatic unilateral knee osteoarthritis (KL grade 1–3) for at least 3 months, who speak English and can attend in-person visits and physical therapy, are the intended participants.
Not a fit: Patients who recently received intraarticular knee injections (within 6 months), have multiple symptomatic lower-extremity joints, recent knee surgery (<1 year), total knee replacement or hardware in the knee, platelet disorders, or other exclusion criteria are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the study could reveal protein changes that help predict who responds to PRP and guide better use of PRP for knee osteoarthritis.
How similar studies have performed: Prior clinical studies of PRP for knee osteoarthritis have shown mixed symptom benefits, and direct biomarker comparisons against saline are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. Grade 1-3 KL score will be recruited; 2. Symptoms of knee osteoarthritis for at least 3 months before presentation in one knee; 3. Have symptomatic complaints from osteoarthritis pain in no other joint affecting the hips, ankles or unaffected knee; 4. Will be able to attend and perform physical therapy. 5. English-speaking Exclusion Criteria 1\. Patients will be excluded if: 1. Received injection therapy for knee osteoarthritis in the past 6 months 2. Have signs of concomitant osteoarthritis of 1 or more other major joints of the lower extremities that impair their daily activity level 3. History of septic arthritis 4. Have underwent a previous knee surgery specifically for osteoarthritis or osteochondral defects less than 1 year before randomization (i.e. autograft or allograft surgery 5. High tibial osteotomy, partial knee replacement, patellar resurfacing), total knee replacement or existing surgical hardware in the knee 6. Patient with platelet disorders, bleeding disorder 7. Patient with rheumatologic disease, automimmune disorder, immunocompromised status, active history of cancer 8. Patient taking Chemotherapy, need for regular prednisone or antiinflammatory used 9. Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study. 10. Uncontrolled illness, physical disability, or other contraindication to aerobic exercise training including, but not limited to: i. Acute myocardial Infarction (within 5 days of any planned study procedure); ii. Unstable angina; iii. Uncontrolled arrhythmia causing symptoms or hemodynamic compromise; iv. Recurrent syncope; v. Active endocarditis; vi. Acute myocarditis or pericarditis; vii. Symptomatic severe aortic stenosis; viii. Uncontrolled heart failure; ix. Acute (within 3 months) pulmonary embolus or pulmonary infarction; x. Thrombosis of lower extremities; xi. Suspected dissecting aneurysm; xii. Uncontrolled asthma; xiii. Pulmonary edema; xiv. Room air desaturation at rest ≤85%; xv. Respiratory failure; xvi. Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (ie infection, renal failure, thyrotoxicosis); and xvii. Mental impairment leading to inability to cooperate.
Where this trial is running
San Francisco, California
- University of California — San Francisco, California, United States (Recruiting)
Study contacts
- Principal investigator: Anthony Luke, MD, MPH — University of California, San Francisco
- Study coordinator: Anthony Luke, MD, MPH
- Email: anthony.luke@ucsf.edu
- Phone: 415.502.4548
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.