CellMist™ Autologous Cells to Treat Deep Second-Degree Burns

Exclusion Criteria

• •1. Is pregnant or does not agree to use acceptable contraception methods for the duration of their participation in the clinical trial (latter applies to women and men of child bearing potential);
• •2. Is breast feeding;
• •3. Has a pre-existing local and/or systemic bacterial infection that requires antibiotic treatment for more than 2 days prior to study treatment;
• •4. Demonstrates an anesthesia risk that (as determined by the Principal Investigator) prohibits treatment
• •5. Body Mass Index (BMI) ≥ 39;
• •6. The burn(s) at the target treatment area(s) results from chemical, electrical or radiation exposure;
• •7. Has full thickness (III°) burns TBSA ≥ 20%
• •8. Has comorbidities and/or medications and/or health status that (as determined by the Principal Investigator) could result in poor cell isolation and/or poor wound healing (e.g., uncontrolled and/or significant diabetes (≥8% HbA1c by medical record), peripheral vascular disease, active malignancy or treatment (other than surgery) of malignancy within the past 3 months, autoimmune disease, renal failure (glomerular filtration rate \<60mL/minute) and/or systemic steroid usage);
• •9. Known hypersensitivities to trypsin, collagenase, or GentLyase (dispase);
• •10. Has a medical condition that would make life expectancy \< 12 months;
• •11. Is currently participating in another prospective investigational clinical trial;
• •12. Does not agree to abstain from enrolling in any other study for the duration of this study;
• •13. Gram staining of SkinGun™ cell suspension output shows excessive microbial bioburden (≥ 200 microbial particles/field)