Safety of Extracellular Vesicles for Burn Wounds

Inclusion Criteria:

1. Eighteen years of age or older with deep second degree thermal burn wounds

2. Index burn injury within the prior 72 hours

3. Subjects must understand and be willing and able to give written informed consent

4. Subjects must agree to have blood draws performed per protocol

5. Subjects must be accessible for wound treatment and assessment visits

6. Males and females must agree to use an acceptable method of contraception.Exceptions will be females of non-childbearing age and monogamous males who arepartners of females of non-childbearing age. Acceptable methods of birth controlinclude; history of sterilization, oral contraceptives, depo-progesteroneinjections, a barrier contraceptive such as a condom with or without spermicidecream or gel, diaphragms or cervical cap with or without spermicide cream or gel, oran intrauterine device (IUD).

7. Maximum index wound size at screening limited to single or multiple wounds (in adefined anatomical area) cumulatively ≤ 600 cm2. Minimum wound size at screening: 30cm2. Other wounds may be present that are treated separately from this protocolsubject to the maximum TBSA exclusion criteria listed below.

Exclusion Criteria:

1. Solely first degree or solely third degree burns

2. Cumulative burn area ≥ 20% TBSA (20% TBSA corresponds to 3700 cm2 in a 70 kg, 175 cmsubject)

3. Burns that occur over a previous scar

4. Chemical, radiation, or electrical burns

5. Subjects with superficial second degree burn who are expected to heal within 2 weekswith standard therapy

6. Evidence of active infection at the wound site

7. Evidence of significant wound healing prior to treatment

8. Burn wounds requiring surgery (other than debridement), or skin grafting

9. Wound exclusively located in the area of fingers, toes, face, or perineum

10. Wound that extends > 50% across one or more joints

11. Have any requirement for the use of systemic steroids or immunosuppressivemedications

12. Subjects allergic to human albumin, streptomycin, or penicillin

13. Be a pregnant female or nursing mother

14. Subjects who are known or found to be HIV positive

15. History of alcohol or substance abuse requiring treatment within the past 12 months.

16. Severe medical conditions

17. Malignancy (other than non-melanoma skin cancer) not in remission or inremission less than 5 years

18. Life expectancy less than two years

19. Severe cardiopulmonary disease restricting ambulation to the clinical facility

20. WBC <3 or > 20 x109/L, Hgb < 9g/dL, platelet count 100x109/L or less, serumcreatinine > 1.5 times the upper normal limit, AST or ALT > 2.4 times upper normallimit

21. Known history of coagulopathy

22. Subjects who have a reasonable likelihood of being a recipient of tissue or organtransplantation

23. History of poor compliance, unreliability