Autologous Platelet-Rich Plasma Therapy in the Treatment of Pyoderma Gangrenosum

Inclusion Criteria:

1. Have given written informed consent before participating in any study-specificactivity.

2. Have a clinical diagnosis of classic PG as determined by the principal investigatorbased on results from clinical, histological, and laboratory assessments.

3. Have at least 2 PG ulcer characterized by 'item a' AND 3/5 features in 'item b' OR 2/5 features in 'item b' with support from one of the conditions listed in c. a.Stable or increasing size within 2 months preceding screening by patient report ordocumentation. b. Features such as violaceous border, undermining, cribriformscarring, pustules, peristomal location. c. Identifiable secondary systemiccondition, such as IBD, arthritis, MGUS, noncancerous hematologic disease,streptococcal carriage, levamisole-tainted cocaine, Bruton's agammaglobulinemia.

4. Have at least two PG target ulcers that have an area = 2 cm2 and = 200 cm2 atscreening.

5. Age at least 18 years at screening.

6. A negative pregnancy test (for females of childbearing potential) at both screeningand at Day 0.

7. PARACELSUS Score for pyoderma gangrenosum of 10 or greater.

Exclusion Criteria:

1. Any condition (e.g., psychiatric illness, severe alcoholism, or drug abuse) orsituation that may compromise the ability of the subject to give written informedconsent, may put the subject at significant risk, may jeopardize the subject'ssafety after treatment, may confound the study results, or may interferesignificantly with the subject's participation in the study.

2. History of malignancy within 2 years of screening other than carcinoma in situ ofthe cervix or adequately treated, non-metastatic, squamous, or basal cell carcinomaof the skin.

3. History of seropositivity for HIV antibody; active or carrier status of hepatitis B [surface antigen (HBsAg) positive, or core antibody (anti-HBc) positive withnegative surface antibody]; active hepatitis C (i.e., not treated or not clearedspontaneously, as confirmed by HCV PCR).

4. Patients with hemodynamic instability, bleeding disorders, and/or plateletdysfunction syndrome.

5. A complete blood count will be performed for each participant at the beginning ofthe study and those with serum hemoglobin concentration <11 g/ dL or hematocrit <34%or platelet count<1, 00000/ml will be excluded from the study.

6. Patients with uncontrolled secondary systemic disease in the opinion of theinvestigator.

7. Systemic infection or active local infection requiring oral antibiotics within 2weeks of Day 0.

8. History of the following treatments:

9. Patients taking anticoagulant medication.

10. Changes (addition, discontinuation, or changes in dose) in immunosuppressivemedication (including cyclosporine, azathioprine, methotrexate, mycophenolatemofetil, apremilast, dapsone, or corticosteroids) and biologics (Anti-TNF orother biologic therapies) within 2 months of Day 0.

11. Systemic corticosteroids > 20 mg per day (prednisone or prednisone equivalent)within 8 weeks of Day 0 or change in dose within 4 weeks of Day 0. Steroids maybe tapered (although not increased above the Day 0 dose) during the trial asdetermined by the principal investigator.

12. Intralesional corticosteroids within 8 weeks of day 0; topical immunomodulatorsare also not permitted.

13. Systemic antibiotics within 2 weeks of Day 0.

14. Hyperbaric treatment within 4 weeks of Day 0.

15. Investigational drug or investigational device within 4 weeks of Day 0.

16. Other treatments not described above should be maintained at a stable dose andfrequency throughout the study as best as possible.

17. Major, general surgery within 3 months of screening, or anticipated general surgeryduring the study period.

18. Pregnancy plans to become pregnant during the study, delivery within 3 months ofscreening, or breastfeeding.

19. If previous use of cyclosporine or systemic corticosteroids, failure to have anystabilization/response is exclusionary. This potentially indicates the disease isnot PG.