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NCT Number: NCT07491367

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of California San Francisco

San Francisco, California, 94158, United States

Location contact

Anthony Luke, MD

PRINCIPAL_INVESTIGATOR

Jocelyn Carpio

CONTACT

[email protected]

415-502-4548

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Emcyte PurePRP Supraphysiologic Concentrating System

Device

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

APEX Biologix XCELL PRP System

Device

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

Primary outcomes

  1. Cellular composition and quantity using Horiba Cell counter

    Time frame: Day 1

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

Secondary outcomes

  1. Platelet Activation

    Time frame: Day 1

    Compare platelet activation state, aggregation capacity, and transcriptome between PRP manufacturing systems.

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

    Time frame: Enrollment to 6 months.

    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).

  3. Patient Reported Outcome: Short Form-12 Health Survey

    Time frame: Enrollment to 6 months

    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.

  4. Activity Monitor & PRP Characteristics

    Time frame: Enrollment to 6 months

    Link PRP count and characteristics to change from baseline activity to 6 months as assessed by activity sensors.

  5. Patient Reported Outcomes: Visual Analog Scale

    Time frame: Enrollment to 6 months

    Link PRP characteristics to change from baseline in Pain at 6 months as assessed by Visual Analog Scale (VAS).

Study contacts

Contact information is provided by the study sponsor or research team.

Jocelyn Carpio

CONTACT

[email protected]

415-502-4548

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Acronym: PRP-PEPC

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Mar 24, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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