PRP-KOBE
Study of Platelet Rich Plasma (PRP) Injections With Symptomatic Knee Osteoarthritis for Biomarker Exploration in Young and Old Human Subjects
Sponsor study identifier
interventional
60
1 country
1
Study Start
June 1, 2024
Actual (reported)Primary Completion
February 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 30, 2024
Actual (reported)June 1, 2024
Actual (reported)June 11, 2024
Actual (reported)February 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
February 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
To determine the Intra-individual change in specific proteins in the peripheral blood
12 weeks
To determine the Protein Changes in the synovial vluid
2 weeks and 12 weeks
Examine Differences by Age
2 weeks and 12 weeks
Change in Visual Analog Pain Scores
2 weeks, 12 weeks and 26 weeks
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.
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.
Bloods will be drawn prior to the PRP injection, and repeated at 2 weeks, 12 weeks, possibly 14 weeks for crossover patients follow up visits. Under aseptic technique with a surgical drape/curtain in place to block the study subject's view of the knee. Syringes will be covered with aluminum foil and subjects will have a cover over their eyes, so that neither subjects nor the clinical investigator will know if the injection delivered is PRP injection or a normal saline injection
University of California
San Francisco, California, 94158, United States
Van Blarigan EL, Kenfield SA, Olshen A, Panchal N, Encabo K, Tenggara I, Graff RE, Bang AS, Shinohara K, Cooperberg MR, Carroll PR, Jones LW, Winters-Stone K, Luke A, Chan JM. Effect of a Home-based Walking Intervention on Cardiopulmonary Fitness and Quality of Life Among Men with Prostate Cancer on Active Surveillance: The Active Surveillance Exercise Randomized Controlled Trial. Eur Urol Oncol. 2024 Jun;7(3):519-526. doi: 10.1016/j.euo.2023.10.012. Epub 2023 Oct 29.
Schroer AB, Ventura PB, Sucharov J, Misra R, Chui MKK, Bieri G, Horowitz AM, Smith LK, Encabo K, Tenggara I, Couthouis J, Gross JD, Chan JM, Luke A, Villeda SA. Platelet factors attenuate inflammation and rescue cognition in ageing. Nature. 2023 Aug;620(7976):1071-1079. doi: 10.1038/s41586-023-06436-3. Epub 2023 Aug 16.
Anthony Luke, MD, MPH
University of California, San Francisco
First Submitted
May 30, 2024
First Posted
June 11, 2024
Study Start
June 1, 2024
Actual (reported)The Eppendorf Centrifuge is used to make the PRP. In our opinion, the centrifuge is a nonsignificant risk device. The centrifuge, sterile vials for blood collection and PRP injection syringes do not present a potential risk for serious health, safety or welfare of a subject. It is not needed to support or sustain human life. It is not of substantial importance in diagnosis, curing, mitigating or treating disease for the health, safety and welfare of the patients. There are no potential for serious risk to the health, safety or welfare of a subject.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Langlais CS, Chen YH, Van Blarigan EL, Chan JM, Ryan CJ, Zhang L, Borno HT, Newton RU, Luke A, Bang AS, Panchal N, Tenggara I, Schultz B, Lavaki E, Pinto N, Aggarwal R, Friedlander T, Koshkin VS, Harzstark AL, Small EJ, Kenfield SA. Quality of life for men with metastatic castrate-resistant prostate cancer participating in an aerobic and resistance exercise pilot intervention. Urol Oncol. 2023 Mar;41(3):146.e1-146.e11. doi: 10.1016/j.urolonc.2022.11.016. Epub 2022 Dec 15.
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.
Tangtiphaiboontana J, Figoni AM, Luke A, Zhang AL, Feeley BT, Ma CB. The effects of nonsteroidal anti-inflammatory medications after rotator cuff surgery: a randomized, double-blind, placebo-controlled trial. J Shoulder Elbow Surg. 2021 Sep;30(9):1990-1997. doi: 10.1016/j.jse.2021.05.018. Epub 2021 Jun 24.
Lazaro RM, Souza RB, Luke AC. Patellar mobility and lower limb kinematics during functional activities in individuals with and without patellar tendinopathy. Knee. 2021 Jun;30:241-248. doi: 10.1016/j.knee.2021.04.002. Epub 2021 May 3.
Krabak BJ, Roberts WO, Tenforde AS, Ackerman KE, Adami PE, Baggish AL, Barrack M, Cianca J, Davis I, D'Hemecourt P, Fredericson M, Goldman JT, Harrast MA, Heiderscheit BC, Hollander K, Kraus E, Luke A, Miller E, Moyer M, Rauh MJ, Toresdahl BG, Wasfy MM. Youth running consensus statement: minimising risk of injury and illness in youth runners. Br J Sports Med. 2021 Mar;55(6):305-318. doi: 10.1136/bjsports-2020-102518. Epub 2020 Oct 29.
Lau BC, Motamedi D, Luke A. Use of Pocket-Sized Ultrasound Device in the Diagnosis of Shoulder Pathology. Clin J Sport Med. 2020 Jan;30(1):20-24. doi: 10.1097/JSM.0000000000000577.
Mah CD, Sparks AJ, Samaan MA, Souza RB, Luke A. Sleep restriction impairs maximal jump performance and joint coordination in elite athletes. J Sports Sci. 2019 Sep;37(17):1981-1988. doi: 10.1080/02640414.2019.1612504. Epub 2019 May 24.
Primary Completion
February 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
February 16, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
September 8, 2026
Record last verified: 2026-09
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