Pilot Exploration of Platelet Characterization of Platelet Rich Plasma Created by Two Different Systems
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Platelet Rich Plasma
Biological/VaccineThe 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
DevicePlatelet Rich Plasma (PRP) will be made by the Emcyte PurePRP Supraphysiologic Concentrating System.
APEX Biologix XCELL PRP System
DevicePlatelet Rich Plasma (PRP) will be made by APEX Biologix XCELL PRP System.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: APEX Biologix XCELL PRP SystemActive comparator 2 interventions
Group B: Emcyte PurePRP Supraphysiologic Concentrating SystemActive comparator 2 interventions
Trial outcomes
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.
Time frame
Day 1Secondary outcomes
1
Platelet Activation
Compare platelet activation state, aggregation capacity, and transcriptome between PRP manufacturing systems.
Time frame
Day 12
Patient Reported Outcomes: Western Ontario and McMaster Universities Arthritis Index (WOMAC)
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).
Time frame
Enrollment to 6 months.3
Patient Reported Outcome: Short Form-12 Health Survey
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.
Time frame
Enrollment to 6 months4
Activity Monitor & PRP Characteristics
Link PRP count and characteristics to change from baseline activity to 6 months as assessed by activity sensors.
Time frame
Enrollment to 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov