Pilot Synovial Fluid Molecular/Stem Cell Response to PRP in Knee Osteoarthritis: Clinical & Imaging Outcome Correlation

In this study 18 subjects with mild to moderate symptomatic knee osteoarthritis will be
recruited per an IRB approved protocol with explicit inclusion and exclusion criteria.
Subjects who are enrolled and meet all criteria will be blinded and randomized (2:1) to
receive Platelet Rich Plasma or normal saline "control". Prior to the intervention, a
synovial fluid aspiration will occur. At follow up number one (approximately 10 days from
baseline) a repeat aspiration will occur and a differential analysis of the molecular and
biochemical effects will be undertaken; this data will serve as the primary outcome
measures. This data will be correlated to clinical and imaging outcome measures which will
be secondary outcome measures completed at baseline and intermittently throughout the study.
The duration of the study is one year.

Inclusion Criteria:

1. Early/Mild to Moderate Stage knee osteoarthritis (KOA), as determined by
Kellgren-Lawrence Grade 2 to 3 on PA standing radiograph within the past three
months;

- A prospective subject who has a diagnosis of non-end stage KOA (i.e., a
potential study candidate) and expresses interest in participating but has no
XRAY within the specified time-period will be sent for a fresh XRAY. This XRAY
will be read by a radiologist & be paid for by the study.

2. >=40 years of age;

3. Average 100-point VAS score of >50, on average, within the past 3 months*, with KOA
felt to be the primary contributor to pain.

- Alternate 10-point scales with pain scores averaging >5 may be considered if the
prospective subject also completes a VAS with score >50 at screening.

4. Exam consistent with KOA being primary etiology of pain;

5. No signs of inflammatory arthropathy in medical record, history or physical
examination;

6. A >3 millimeter intra-articular (IA) effusion present on ultrasound evaluation.

7. [If a chronic liver or renal disease patient, evidence of stable disease over/within
the past six months, else exclusion.]

8. Veteran receiving care at McGuire VAMC.

Exclusion Criteria:

1. Morbid obesity (BMI >40);

2. Poorly controlled diabetes (hemoglobin A1C > 7.5 or fasting blood glucose of >200) in
last 6 months;

3. Ipsilateral knee surgery, trauma within last 6 months, or corticosteroid injection
within 3 months.

4. 4. History of inflammatory arthropathy (RA, SLE or crystalline arthritis of the
knee)**;

5. Any rheumatoid arthritis or gout diagnosis is exclusionary.

6. Current infection of the affected joint or any other uncontrolled or untreated active
infection.

7. Moderate to severe anemia (hemoglobin < 11 g/dl) or thrombocytopenia (platelet count
< 100,000); Hemoglobin >17 g/dl or <11 g/dl and/or platelet counts >500,000 or
<100,000 platelets/μl.

- [CBC obtained within 6 months will be required, even if obtained at initial
screening visit.]

8. Individuals on dialysis, with liver failure, or uncontrolled renal or liver disease
are excluded.

- In those with chronic renal or liver disease, documentation of stable disease
within the most recent 6 months will be required.

9. Individuals on a therapeutic anticoagulant (e.g., Warfarin, Dabigatran, Enoxaparin)
and those with a history of coagulopathy are excluded.

- Per standard clinical practice, subjects on anti-platelet therapy are not
excluded.

10. Pregnancy or breast-feeding;

- Female subjects of child-bearing potential must have a negative pregnancy screen
prior to enrollment.

- Female subjects of child-bearing potential must confirm they are not actively
breast-feeding prior to enrollment.

11. Current illicit drug abuse / active alcohol abuse (i.e, Current substance abuse);

12. Uncontrolled psychiatric disorder;

13. Lack of transportation (i.e., to get to/from appointments at VAMC) and/or willingness
to attend study appointments (screening/consent, Intervention, Day10-follow-up,
Month-6 follow-up, and then visits over-the-phone / in-person / or via Telehealth for
Month-3 and Month-12;

14. Advanced or currently active cancer.

15. Blood disorders (such as Sickle Cell Anemia, TTP, others)

16. Vulnerable populations: Individuals incapable of making informed decisions will not
be enrolled, nor will those under some form of incarceration.