Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems

Обзор

The investigators would like to study the differences in the quality of Platelet Rich Plasma (PRP) between two different machines in those with knee osteoarthritis. Knee osteoarthritis means your cartilage has been worn down, and it affects your knee joint. Both machines, the APEX Biologix XCELL PRP System and the Emcyte PurePRP Supraphysiologic Concentrating System, are FDA approved, commercially available, and makes PRP. The investigators will check if the platelets in the PRP have different amounts or work differently. The investigators will also assess participants symptoms after the injection and compare the two different preparation systems.

Вмешательства

• Биопрепарат Platelet Rich Plasma
  The Platelet Rich Plasma (PRP) participants will receive in this study will be made by Emcyte PurePRP Supraphysiologic Concentrating System or the APEX Biologix XCELL PRP System.
• Устройство Emcyte PurePRP Supraphysiologic Concentrating System
  Platelet Rich Plasma (PRP) will be made by the Emcyte PurePRP Supraphysiologic Concentrating System.
• Устройство APEX Biologix XCELL PRP System
  Platelet Rich Plasma (PRP) will be made by APEX Biologix XCELL PRP System.

Первичные конечные точки

• Cellular composition and quantity using Horiba Cell counter [Срок оценки: Day 1]

Вторичные конечные точки (5)

• Platelet Activation [Срок оценки: Day 1]
• Patient Reported Outcomes: Western Ontario and McMaster Universities Arthritis Index (WOMAC) [Срок оценки: Enrollment to 6 months.]
• Patient Reported Outcome: Short Form-12 Health Survey [Срок оценки: Enrollment to 6 months]
• Activity Monitor & PRP Characteristics [Срок оценки: Enrollment to 6 months]
• Patient Reported Outcomes: Visual Analog Scale [Срок оценки: Enrollment to 6 months]

Критерии участия

Критерии включения

• Kellgren-Lawrence (KL) Grade 1-3 knee osteoarthritis
• Symptoms of knee osteoarthritis for at least 3 months before presentation in one knee
• Will be able to attend and perform physical therapy

Критерии исключения

• Received injection therapy for knee osteoarthritis in the past 6 months
• Have severe arthritis diagnosed in ≥1 major joint by radiology criteria
• History of septic arthritis
• Underwent knee surgery for osteoarthritis or osteochondral defects within 1 year before randomization (e.g., autograft or allograft surgery)
• Have had high tibial osteotomy, partial knee replacement, patellar resurfacing, total knee replacement, or have existing surgical hardware in the knee
• Received a platelet-rich plasma injection elsewhere in the body within the past 3 months
• Have a platelet disorder or bleeding disorder
• Have a rheumatologic disease, autoimmune disorder, immunocompromised status, or active history of cancer
• Are taking chemotherapy, require regular prednisone, or require regular anti-inflammatory use
• Are pregnant, breastfeeding, or unwilling to practice birth control during the study
• If both knees have osteoarthritis and the other knee has KL score equal to or greater than 2.
• Have uncontrolled illness, physical disability, or other contraindication to aerobic exercise training

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of California San Francisco — San Francisco

Публикации

• Elgaddal N, Weeks JD. Yoga Among Adults Age 18 and Older: United States, 2022. NCHS Data Brief. 2024 Jun;(501):10.15620/cdc/156474. doi: 10.15620/cdc/156474. PMID 39147377
• Lana JFSD, Purita J, Paulus C, Huber SC, Rodrigues BL, Rodrigues AA, Santana MH, Madureira JL Jr, Malheiros Luzo AC, Belangero WD, Annichino-Bizzacchi JM. Contributions for classification of platelet rich plasma - proposal of a new classification: MARSPILL. Regen Med. 2017 Jul;12(5):565-574. doi: 10.2217/rme-2017-0042. Epub 2017 Jul 31. PMID 28758836
• Deshpande BR, Katz JN, Solomon DH, Yelin EH, Hunter DJ, Messier SP, Suter LG, Losina E. Number of Persons With Symptomatic Knee Osteoarthritis in the US: Impact of Race and Ethnicity, Age, Sex, and Obesity. Arthritis Care Res (Hoboken). 2016 Dec;68(12):1743-1750. doi: 10.1002/acr.22897. Epub 2016 Nov 3. PMID 27014966
• Leifer VP, Katz JN, Losina E. The burden of OA-health services and economics. Osteoarthritis Cartilage. 2022 Jan;30(1):10-16. doi: 10.1016/j.joca.2021.05.007. Epub 2021 May 20. PMID 34023527
• Zhao X, Shah D, Gandhi K, Wei W, Dwibedi N, Webster L, Sambamoorthi U. Clinical, humanistic, and economic burden of osteoarthritis among noninstitutionalized adults in the United States. Osteoarthritis Cartilage. 2019 Nov;27(11):1618-1626. doi: 10.1016/j.joca.2019.07.002. Epub 2019 Jul 9. PMID 31299387
• Jawanda H, Khan ZA, Warrier AA, Acuna AJ, Allahabadi S, Kaplan DJ, Ritz E, Jackson GR, Mameri ES, Batra A, Dornan G, Westrick J, Verma NN, Chahla J. Platelet-Rich Plasma, Bone Marrow Aspirate Concentrate, and Hyaluronic Acid Injections Outperform Corticosteroids in Pain and Function Scores at a Minimum of 6 Months as Intra-Articular Injections for Knee Osteoarthritis: A Systematic Review and Netwo PMID 38331363
• Dai WL, Zhou AG, Zhang H, Zhang J. Efficacy of Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Meta-analysis of Randomized Controlled Trials. Arthroscopy. 2017 Mar;33(3):659-670.e1. doi: 10.1016/j.arthro.2016.09.024. Epub 2016 Dec 22. PMID 28012636
• Moussa M, Lajeunesse D, Hilal G, El Atat O, Haykal G, Serhal R, Chalhoub A, Khalil C, Alaaeddine N. Platelet rich plasma (PRP) induces chondroprotection via increasing autophagy, anti-inflammatory markers, and decreasing apoptosis in human osteoarthritic cartilage. Exp Cell Res. 2017 Mar 1;352(1):146-156. doi: 10.1016/j.yexcr.2017.02.012. Epub 2017 Feb 13. PMID 28202394

Идентификаторы

NCT: NCT07491367 · 25-45033

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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