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

NCT07491367 | Not Yet Recruiting Phase 4 FDA Drug FDA Device

• 1 other identifier: 25-45033
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Knee Osteoarthristis; Cartilage Damage; Platelet Rich Plasma; Platelet Rich Plasma Injection

Outcome Measures

Primary Outcomes (1)

• Cellular composition and quantity using Horiba Cell counter

  Compare cellular composition and quantifying PRP products between EmCyte PurePRP versus APEX Biologix XCELL PRP manufacturing systems using a Horiba Cell counter.

  Day 1

Secondary Outcomes (5)

• Platelet Activation

  Day 1

• Patient Reported Outcomes: Western Ontario and McMaster Universities Arthritis Index (WOMAC)

  Enrollment to 6 months.

• Patient Reported Outcome: Short Form-12 Health Survey

  Enrollment to 6 months

• Activity Monitor & PRP Characteristics

  Enrollment to 6 months

• Patient Reported Outcomes: Visual Analog Scale

  Enrollment to 6 months

Study Arms (2)

APEX Biologix XCELL PRP System

ACTIVE COMPARATOR

Participants in this group will receive Platelet Rich Plasma made by the APEX Biologix XCELL PRP System.

Biological: Platelet Rich Plasma; Device: APEX Biologix XCELL PRP System

Emcyte PurePRP Supraphysiologic Concentrating System

ACTIVE COMPARATOR

Participants in this group will receive Platelet Rich Plasma made by Emcyte PurePRP Supraphysiologic Concentrating System.

Biological: Platelet Rich Plasma; Device: Emcyte PurePRP Supraphysiologic Concentrating System

Interventions

Platelet Rich Plasma BIOLOGICAL

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.

APEX Biologix XCELL PRP System; Emcyte PurePRP Supraphysiologic Concentrating System

Emcyte PurePRP Supraphysiologic Concentrating System DEVICE

Platelet Rich Plasma (PRP) will be made by the Emcyte PurePRP Supraphysiologic Concentrating System.

Emcyte PurePRP Supraphysiologic Concentrating System

APEX Biologix XCELL PRP System DEVICE

Platelet Rich Plasma (PRP) will be made by APEX Biologix XCELL PRP System.

APEX Biologix XCELL PRP System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California San Francisco

San Francisco, California, 94158, United States

Location

Related Publications (27)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 38331363 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 24192391 BACKGROUND

• 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: 19216642 BACKGROUND

• 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: 28352802 BACKGROUND

• 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: 36982439 BACKGROUND

• 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: 36675025 BACKGROUND

• 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: 29337592 BACKGROUND

• 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: 38513880 BACKGROUND

• 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: 39331322 BACKGROUND

• 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: 39134218 BACKGROUND

• 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: 31034242 BACKGROUND

• 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: 35103547 BACKGROUND

• 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: 32398285 BACKGROUND

• 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: 36270110 BACKGROUND

• 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: 38961773 BACKGROUND

• 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: 38295392 BACKGROUND

• 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: 38436492 BACKGROUND

• 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: 33155867 BACKGROUND

• 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: 24725317 BACKGROUND

• 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.

  PMID: 26473014 BACKGROUND

Study Officials

• Anthony Luke, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jocelyn Carpio

CONTACT

415-502-4548; Jocelyn.carpio@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 24, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 9, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)