Osteoarthritis Clinical Trial
— PRP-KOBEOfficial title:
Study of Platelet Rich Plasma (PRP) Injections With Symptomatic Knee Osteoarthritis for Biomarker Exploration in Young and Old Human Subjects
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.
Status | Not yet recruiting |
Enrollment | 60 |
Est. completion date | December 18, 2025 |
Est. primary completion date | December 18, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco |
United States,
Kenfield SA, Van Blarigan EL, Panchal N, Bang A, Zhang L, Graff RE, Chen YH, Ryan CJ, Luke A, Newton RU, Tenggara I, Schultz B, Wang E, Lavaki E, Zuniga K, Pinto N, Borno H, Aggarwal R, Friedlander T, Koshkin VS, Harzstark A, Small E, Chan JM. Feasibility, safety, and acceptability of a remotely monitored exercise pilot CHAMP: A Clinical trial of High-intensity Aerobic and resistance exercise for Metastatic castrate-resistant Prostate cancer. Cancer Med. 2021 Nov;10(22):8058-8070. doi: 10.1002/cam4.4324. Epub 2021 Oct 12. — View Citation
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Van Blarigan EL, Chan JM, Sanchez A, Zhang L, Winters-Stone K, Liu V, Macaire G, Panchal N, Graff RE, Tenggara I, Luke A, Simko JP, Cooperberg MR, Carroll PR, Kenfield SA. Protocol for a 4-arm randomized controlled trial testing remotely delivered exercise-only, diet-only, and exercise + diet interventions among men with prostate cancer treated with radical prostatectomy (Prostate 8-II). Contemp Clin Trials. 2023 Feb;125:107079. doi: 10.1016/j.cct.2023.107079. Epub 2023 Jan 5. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | To determine the Protein Changes in the synovial vluid | Using proteomic analysis of the synovial fluid at the knee, compare the protein alterations caused by an autologous PRP dose (5 mL) to the normal saline control. For proteomic analysis of synovial fluid, the samples will undergo quantitative mass spectrometry, with higher numbers indicating more proteins and lower numbers meaning less proteins. | 2 weeks and 12 weeks | |
Other | Examine Differences by Age | Protein alterations in blood and synovial fluid following knee injections. For each arm, investigator will compare groups of young people (18-45 years old) and older people (46-70 years old) independently. | 2 weeks and 12 weeks | |
Other | Change in Visual Analog Pain Scores | Pain will be measured using the Visual Analog Pain Scores, the score ranges from 0-10, zero indicating no pain and 10 being the worst pain ever. | 2 weeks, 12 weeks and 26 weeks | |
Other | Changes in Knee Injury and Osteoarthritis Outcome Scores (KOOS scores) | Knee Injury and Osteoarthritis Outcome Scores (KOOS scores), the score ranges from 0-100, with 0 representing extreme knee problems and 100 representing no knee problems. | 2 weeks, 12 weeks and 26 weeks | |
Primary | Identify Protein Changes in Platelet Rich Plasma (PRP) | The protein changes from a single autologous PRP injection (5 mL) vs normal saline control, using proteomic analysis of' venous blood samples. For proteomic analysis of Platelet poor plasma (PPP) and PRP, the samples will undergo quantitative mass spectrometry, with higher numbers indicating more proteins and lower numbers meaning less proteins. | 2 weeks | |
Secondary | To determine the Intra-individual change in specific proteins in the peripheral blood | Changes in specific proteins in the blood will be different (e.g., higher or lower) after the 5 mL PRP injection compared to a normal saline control using proteomic analysis. PPP and PRP samples will undergo quantitative mass spectrometry, with higher numbers indicating more proteins and lower numbers meaning less proteins. | 12 weeks |
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