Cartilage Damage, Knee Osteoarthristis, Platelet Rich Plasma, Platelet Rich Plasma Injection
Conditions
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.
Interventions
BIOLOGICALPlatelet 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.
DEVICEEmcyte PurePRP Supraphysiologic Concentrating System
Platelet Rich Plasma (PRP) will be made by the Emcyte PurePRP Supraphysiologic Concentrating System.
DEVICEAPEX Biologix XCELL PRP System
Platelet Rich Plasma (PRP) will be made by APEX Biologix XCELL PRP System.
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cellular composition and quantity using Horiba Cell counter | 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
| Measure | Time frame | Description |
|---|---|---|
| Platelet Activation | Day 1 | Compare platelet activation state, aggregation capacity, and transcriptome between PRP manufacturing systems. |
| Patient Reported Outcomes: Western Ontario and McMaster Universities Arthritis Index (WOMAC) | 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). |
| Patient Reported Outcome: Short Form-12 Health Survey | 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. |
| Activity Monitor & PRP Characteristics | Enrollment to 6 months | Link PRP count and characteristics to change from baseline activity to 6 months as assessed by activity sensors. |
| Patient Reported Outcomes: Visual Analog Scale | Enrollment to 6 months | Link PRP characteristics to change from baseline in Pain at 6 months as assessed by Visual Analog Scale (VAS). |
Countries
United States
Contacts
CONTACTJoel Kopcow
PRINCIPAL_INVESTIGATORAnthony Luke, MD
University of California, San Francisco
Outcome results
None listed