Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems (PRP-PEPC)

March 18, 2026 updated by: University of California, San Francisco
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94158
        • University of California San Francisco
        • Contact:
        • Principal Investigator:
          • Anthony Luke, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: APEX Biologix XCELL PRP System
Participants in this group will receive Platelet Rich Plasma made by the APEX Biologix XCELL PRP System.
Biological: 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.
Device: APEX Biologix XCELL PRP System
Platelet Rich Plasma (PRP) will be made by APEX Biologix XCELL PRP System.
Active Comparator: Emcyte PurePRP Supraphysiologic Concentrating System
Participants in this group will receive Platelet Rich Plasma made by Emcyte PurePRP Supraphysiologic Concentrating System.
Biological: 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.
Device: Emcyte PurePRP Supraphysiologic Concentrating System
Platelet Rich Plasma (PRP) will be made by the Emcyte PurePRP Supraphysiologic Concentrating System.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Platelet Activation
Time Frame: Day 1
Compare platelet activation state, aggregation capacity, and transcriptome between PRP manufacturing systems.
Day 1
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).
Enrollment to 6 months.
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.
Enrollment to 6 months
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.
Enrollment to 6 months
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).
Enrollment to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Anthony Luke, MD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

September 1, 2028

Study Registration Dates

First Submitted

February 25, 2026

First Submitted That Met QC Criteria

March 18, 2026

First Posted (Actual)

March 24, 2026

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 25-45033

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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