Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-05 @ 8:14 AM
Study NCT ID:
NCT07491367
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-24
First Post:
2026-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-02-25', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cellular composition and quantity using Horiba Cell counter', 'timeFrame': 'Day 1', 'description': 'Compare cellular composition and quantifying PRP products between EmCyte PurePRP versus APEX Biologix XCELL PRP manufacturing systems using a Horiba Cell counter.'}], 'secondaryOutcomes': [{'measure': 'Platelet Activation', 'timeFrame': 'Day 1', 'description': 'Compare platelet activation state, aggregation capacity, and transcriptome between PRP manufacturing systems.'}, {'measure': 'Patient Reported Outcomes: Western Ontario and McMaster Universities Arthritis Index (WOMAC)', 'timeFrame': 'Enrollment to 6 months.', 'description': 'Link PRP characteristics to change from baseline in Pain, Stiffness, and Physical Function at 6 months as assessed by Western Ontario and McMaster Universities Arthritis Index (WOMAC).'}, {'measure': 'Patient Reported Outcome: Short Form-12 Health Survey', 'timeFrame': 'Enrollment to 6 months', 'description': 'Link PRP characteristics to change from baseline in health and ability to complete usual activities at 6 months as assessed by Short Form-12 Health Survey, a health quality of life survey.'}, {'measure': 'Activity Monitor & PRP Characteristics', 'timeFrame': 'Enrollment to 6 months', 'description': 'Link PRP count and characteristics to change from baseline activity to 6 months as assessed by activity sensors.'}, {'measure': 'Patient Reported Outcomes: Visual Analog Scale', 'timeFrame': 'Enrollment to 6 months', 'description': 'Link PRP characteristics to change from baseline in Pain at 6 months as assessed by Visual Analog Scale (VAS).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Knee Osteoarthristis', 'Cartilage Damage', 'Platelet Rich Plasma', 'Platelet Rich Plasma Injection']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Elgaddal N, Kramarow EA, Weeks JD, et al. Arthritis in adults age 18+: United States, 2022. NCHS Data Brief. 2024;(497).'}, {'pmid': '28758836', 'type': 'BACKGROUND', 'citation': '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': '27014966', 'type': 'BACKGROUND', 'citation': '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': '34023527', 'type': 'BACKGROUND', 'citation': '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': '31299387', 'type': 'BACKGROUND', 'citation': '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': '38331363', 'type': 'BACKGROUND', 'citation': '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 Network Meta-analysis. Arthroscopy. 2024 May;40(5):1623-1636.e1. doi: 10.1016/j.arthro.2024.01.037. Epub 2024 Feb 7.'}, {'pmid': '28012636', 'type': 'BACKGROUND', 'citation': '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': '28202394', 'type': 'BACKGROUND', 'citation': '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': '24192391', 'type': 'BACKGROUND', 'citation': 'Sundman EA, Cole BJ, Karas V, Della Valle C, Tetreault MW, Mohammed HO, Fortier LA. The anti-inflammatory and matrix restorative mechanisms of platelet-rich plasma in osteoarthritis. Am J Sports Med. 2014 Jan;42(1):35-41. doi: 10.1177/0363546513507766. Epub 2013 Nov 5.'}, {'pmid': '19216642', 'type': 'BACKGROUND', 'citation': 'Mishra A, Tummala P, King A, Lee B, Kraus M, Tse V, Jacobs CR. Buffered platelet-rich plasma enhances mesenchymal stem cell proliferation and chondrogenic differentiation. Tissue Eng Part C Methods. 2009 Sep;15(3):431-5. doi: 10.1089/ten.tec.2008.0534.'}, {'pmid': '28352802', 'type': 'BACKGROUND', 'citation': 'Pavlovic V, Ciric M, Jovanovic V, Stojanovic P. Platelet Rich Plasma: a short overview of certain bioactive components. Open Med (Wars). 2016 Aug 12;11(1):242-247. doi: 10.1515/med-2016-0048. eCollection 2016.'}, {'pmid': '36982439', 'type': 'BACKGROUND', 'citation': 'Beitia M, Delgado D, Mercader J, Sanchez P, Lopez de Dicastillo L, Sanchez M. Action of Platelet-Rich Plasma on In Vitro Cellular Bioactivity: More than Platelets. Int J Mol Sci. 2023 Mar 10;24(6):5367. doi: 10.3390/ijms24065367.'}, {'pmid': '36675025', 'type': 'BACKGROUND', 'citation': 'Mariani E, Pulsatelli L, Cattini L, Dolzani P, Assirelli E, Cenacchi A, Di Martino A, Arciola CR, Filardo G. Pure Platelet and Leukocyte-Platelet-Rich Plasma for Regenerative Medicine in Orthopedics-Time- and Preparation-Dependent Release of Growth Factors and Effects on Synovial Fibroblasts: A Comparative Analysis. Int J Mol Sci. 2023 Jan 12;24(2):1512. doi: 10.3390/ijms24021512.'}, {'pmid': '29337592', 'type': 'BACKGROUND', 'citation': "Oudelaar BW, Peerbooms JC, Huis In 't Veld R, Vochteloo AJH. Concentrations of Blood Components in Commercial Platelet-Rich Plasma Separation Systems: A Review of the Literature. Am J Sports Med. 2019 Feb;47(2):479-487. doi: 10.1177/0363546517746112. Epub 2018 Jan 16."}, {'pmid': '38513880', 'type': 'BACKGROUND', 'citation': 'Berrigan WA, Bailowitz Z, Park A, Reddy A, Liu R, Lansdown D. A Greater Platelet Dose May Yield Better Clinical Outcomes for Platelet-Rich Plasma in the Treatment of Knee Osteoarthritis: A Systematic Review. Arthroscopy. 2025 Mar;41(3):809-817.e2. doi: 10.1016/j.arthro.2024.03.018. Epub 2024 Mar 19.'}, {'pmid': '39331322', 'type': 'BACKGROUND', 'citation': 'Berrigan W, Tao F, Kopcow J, Park AL, Allen I, Tahir P, Reddy A, Bailowitz Z. The Effect of Platelet Dose on Outcomes after Platelet Rich Plasma Injections for Musculoskeletal Conditions: A Systematic Review and Meta-Analysis. Curr Rev Musculoskelet Med. 2024 Dec;17(12):570-588. doi: 10.1007/s12178-024-09922-x. Epub 2024 Sep 27.'}, {'pmid': '39134218', 'type': 'BACKGROUND', 'citation': 'Lee CH, Lee CY, You HL, Wu YT, Chen DP. The growth factor content as an indicator of platelet counts in platelet-rich plasma. Clin Chim Acta. 2025 Jan 1;564:119901. doi: 10.1016/j.cca.2024.119901. Epub 2024 Aug 10.'}, {'pmid': '31034242', 'type': 'BACKGROUND', 'citation': 'Ziegler CG, Van Sloun R, Gonzalez S, Whitney KE, DePhillipo NN, Kennedy MI, Dornan GJ, Evans TA, Huard J, LaPrade RF. Characterization of Growth Factors, Cytokines, and Chemokines in Bone Marrow Concentrate and Platelet-Rich Plasma: A Prospective Analysis. Am J Sports Med. 2019 Jul;47(9):2174-2187. doi: 10.1177/0363546519832003. Epub 2019 Apr 29.'}, {'pmid': '35103547', 'type': 'BACKGROUND', 'citation': 'Di Martino A, Boffa A, Andriolo L, Romandini I, Altamura SA, Cenacchi A, Roverini V, Zaffagnini S, Filardo G. Leukocyte-Rich versus Leukocyte-Poor Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Trial. Am J Sports Med. 2022 Mar;50(3):609-617. doi: 10.1177/03635465211064303. Epub 2022 Feb 1.'}, {'pmid': '32398285', 'type': 'BACKGROUND', 'citation': 'Safiri S, Kolahi AA, Smith E, Hill C, Bettampadi D, Mansournia MA, Hoy D, Ashrafi-Asgarabad A, Sepidarkish M, Almasi-Hashiani A, Collins G, Kaufman J, Qorbani M, Moradi-Lakeh M, Woolf AD, Guillemin F, March L, Cross M. Global, regional and national burden of osteoarthritis 1990-2017: a systematic analysis of the Global Burden of Disease Study 2017. Ann Rheum Dis. 2020 Jun;79(6):819-828. doi: 10.1136/annrheumdis-2019-216515. Epub 2020 May 12.'}, {'pmid': '36270110', 'type': 'BACKGROUND', 'citation': 'Li AK, Stavrakis AI, Photopoulos C. Platelet-rich plasma use for hip and knee osteoarthritis in the United States. Knee. 2022 Dec;39:239-246. doi: 10.1016/j.knee.2022.06.006. Epub 2022 Oct 18.'}, {'pmid': '38961773', 'type': 'BACKGROUND', 'citation': 'Kon E, de Girolamo L, Laver L, Andriolo L, Andia I, Bastos R, Beaufils P, Biant L, Boe B, Boffa A, Cugat R, Di Martino A, Erggelet C, Iosifidis M, Kocaoglu B, Magalon J, Marinescu R, Nehrer S, Niemeyer P, Ostojic M, Piontek T, Sanchez M, Sas K, Skarpas G, Tischer T, Vonk L, Filardo G. Platelet-rich plasma injections for the management of knee osteoarthritis: The ESSKA-ICRS consensus. Recommendations using the RAND/UCLA appropriateness method for different clinical scenarios. Knee Surg Sports Traumatol Arthrosc. 2024 Nov;32(11):2938-2949. doi: 10.1002/ksa.12320. Epub 2024 Jul 4.'}, {'pmid': '38295392', 'type': 'BACKGROUND', 'citation': 'Dubin J, Leucht P, Murray M, Pezold R; Staff of the American Academy of Orthopaedic Surgeons on Behalf of the Platelet-Rich Plasma (PRP) for Knee Osteoarthritis Technology Overview Workgroup and Contributors. American Academy of Orthopaedic Surgeons Technology Overview Summary: Platelet-Rich Plasma (PRP) for Knee Osteoarthritis. J Am Acad Orthop Surg. 2024 Apr 1;32(7):296-301. doi: 10.5435/JAAOS-D-23-00957. Epub 2024 Jan 30.'}, {'pmid': '38436492', 'type': 'BACKGROUND', 'citation': 'Laver L, Filardo G, Sanchez M, Magalon J, Tischer T, Abat F, Bastos R, Cugat R, Iosifidis M, Kocaoglu B, Kon E, Marinescu R, Ostojic M, Beaufils P, de Girolamo L; ESSKA-ORBIT Group. The use of injectable orthobiologics for knee osteoarthritis: A European ESSKA-ORBIT consensus. Part 1-Blood-derived products (platelet-rich plasma). Knee Surg Sports Traumatol Arthrosc. 2024 Apr;32(4):783-797. doi: 10.1002/ksa.12077. Epub 2024 Mar 4.'}, {'pmid': '33155867', 'type': 'BACKGROUND', 'citation': 'Magalon J, Brandin T, Francois P, Degioanni C, De Maria L, Grimaud F, Veran J, Dignat-George F, Sabatier F. Technical and biological review of authorized medical devices for platelets-rich plasma preparation in the field of regenerative medicine. Platelets. 2021 Feb 17;32(2):200-208. doi: 10.1080/09537104.2020.1832653. Epub 2020 Nov 6.'}, {'pmid': '24725317', 'type': 'BACKGROUND', 'citation': 'Magalon J, Bausset O, Serratrice N, Giraudo L, Aboudou H, Veran J, Magalon G, Dignat-Georges F, Sabatier F. Characterization and comparison of 5 platelet-rich plasma preparations in a single-donor model. Arthroscopy. 2014 May;30(5):629-38. doi: 10.1016/j.arthro.2014.02.020.'}, {'pmid': '26473014', 'type': 'BACKGROUND', 'citation': 'Oh JH, Kim W, Park KU, Roh YH. Comparison of the Cellular Composition and Cytokine-Release Kinetics of Various Platelet-Rich Plasma Preparations. Am J Sports Med. 2015 Dec;43(12):3062-70. doi: 10.1177/0363546515608481. Epub 2015 Oct 15.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kellgren-Lawrence (KL) Grade 1-3 knee osteoarthritis\n* Symptoms of knee osteoarthritis for at least 3 months before presentation in one knee\n* Will be able to attend and perform physical therapy\n\nExclusion Criteria:\n\n* Received injection therapy for knee osteoarthritis in the past 6 months\n* Have severe arthritis diagnosed in ≥1 major joint by radiology criteria\n* History of septic arthritis\n* Underwent knee surgery for osteoarthritis or osteochondral defects within 1 year before randomization (e.g., autograft or allograft surgery)\n* Have had high tibial osteotomy, partial knee replacement, patellar resurfacing, total knee replacement, or have existing surgical hardware in the knee\n* Received a platelet-rich plasma injection elsewhere in the body within the past 3 months\n* Have a platelet disorder or bleeding disorder\n* Have a rheumatologic disease, autoimmune disorder, immunocompromised status, or active history of cancer\n* Are taking chemotherapy, require regular prednisone, or require regular anti-inflammatory use\n* Are pregnant, breastfeeding, or unwilling to practice birth control during the study\n* If both knees have osteoarthritis and the other knee has KL score equal to or greater than 2.\n* Have uncontrolled illness, physical disability, or other contraindication to aerobic exercise training'}, 'identificationModule': {'nctId': 'NCT07491367', 'acronym': 'PRP-PEPC', 'briefTitle': 'Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems', 'orgStudyIdInfo': {'id': '25-45033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'APEX Biologix XCELL PRP System', 'description': 'Participants in this group will receive Platelet Rich Plasma made by the APEX Biologix XCELL PRP System.', 'interventionNames': ['Biological: Platelet Rich Plasma', 'Device: APEX Biologix XCELL PRP System']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Emcyte PurePRP Supraphysiologic Concentrating System', 'description': 'Participants in this group will receive Platelet Rich Plasma made by Emcyte PurePRP Supraphysiologic Concentrating System.', 'interventionNames': ['Biological: Platelet Rich Plasma', 'Device: Emcyte PurePRP Supraphysiologic Concentrating System']}], 'interventions': [{'name': 'Platelet Rich Plasma', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['APEX Biologix XCELL PRP System', 'Emcyte PurePRP Supraphysiologic Concentrating System']}, {'name': 'Emcyte PurePRP Supraphysiologic Concentrating System', 'type': 'DEVICE', 'description': 'Platelet Rich Plasma (PRP) will be made by the Emcyte PurePRP Supraphysiologic Concentrating System.', 'armGroupLabels': ['Emcyte PurePRP Supraphysiologic Concentrating System']}, {'name': 'APEX Biologix XCELL PRP System', 'type': 'DEVICE', 'description': 'Platelet Rich Plasma (PRP) will be made by APEX Biologix XCELL PRP System.', 'armGroupLabels': ['APEX Biologix XCELL PRP System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Jocelyn Carpio', 'role': 'CONTACT', 'email': 'Jocelyn.carpio@ucsf.edu', 'phone': '415-502-4548'}, {'name': 'Anthony Luke, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Jocelyn Carpio', 'role': 'CONTACT', 'email': 'Jocelyn.carpio@ucsf.edu', 'phone': '415-502-4548'}], 'overallOfficials': [{'name': 'Anthony Luke, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}