MSC EVs in Dystrophic Epidermolysis Bullosa

Inclusion Criteria:

1. Subjects must be 6 months or older at screening.

2. Subjects who have a confirmed diagnosis of DEB based on electron microscopy,immunomapping, or genetic testing. Subjects with severe DEB (e.g., RDEB patientswith absent Col VII/no anchoring fibrils) and milder forms of DEB (e.g., RDEBpatients with reduced Col VII and/or anchoring fibril levels) are eligible.

3. Presence for at least four weeks of two 10 - 50 cm2 wounds (unroofed EB erosions) atleast 4 inches apart that can be considered similar enough in size, wound locationand expected healing characteristics to be a matched pair. Neither index wound mayhave been treated with any local (topical, subcutaneous, etc) or systemictherapeutic other than standard of care treatments described in this protocol (i.e.local or systemic antimicrobials to control infection, topical anesthetic and oralanalgesics if required) in the past 3 months prior to screening.

4. Females of childbearing potential must have a negative urine or serum pregnancy testat screening and agree to continue use of an acceptable form of birth controlthroughout the duration of the study. Acceptable forms of birth control includeoral, implant, injectable, and transdermal contraceptives; an intrauterine device;or other forms considered acceptable by the investigator. A female subject iseligible to participate if she is not pregnant, is not a woman or childbearingpotential (WOCBP), or is a WOCBP who agrees to follow the contraceptive guidanceabove.

5. Post-pubertal males who agree to use an acceptable method of contraception for theduration of the study.

6. Subjects 18 years of age and older must be capable of giving signed informedconsent, which includes compliance with the requirements and restrictions listed inthe informed consent form (ICF) and in this protocol. Subjects under the age of 18years must be capable of giving assent (if age-appropriate), and/or they must have aguardian capable of providing consent.

7. Willing to comply with the protocol requirements.

Note: Reference to Appendix 3 can be located in the protocol

Exclusion Criteria:

1. Concomitant treatment at the time of screening or at any time during the study ofeither study wound (control or AGLE-102 treated) with local or systemic therapyother than standard of care treatments described in this protocol (i.e. local orsystemic antimicrobials to control infection, topical anesthetic and oral analgesicsif required). Concomitant treatment of non-study wounds with local therapy duringthe study is acceptable. Systemic treatment of RDEB wounds (except as noted forstandard of care) during the study is not acceptable. Subjects unwilling to abstainfrom prohibited concomitant treatment of study wounds (treated or control) and/orsystemic treatment of RDEB wounds during the study period are excluded.

2. Either study wound located within 6 inches of wounds treated concurrently with anyother local therapy.

3. Clinical evidence of systemic infection.

4. History of bone marrow transplantation.

5. Diagnosed clinically significant autoimmune disease

6. Wound that extends across the fingers, toes, pubic or perineum region are excludedfrom being index wounds.

7. The subject has clinical evidence of an active infection at the wound site.

8. Current malignancy (including skin cancer), a life expectancy of < 2 years, orsevere cardiopulmonary disease that restricts ambulation to the clinical facility.

9. History of coagulopathy.

10. Chronic use of systemic steroids or immunosuppressive agents.

11. Allergy to human albumin, streptomycin, or penicillin.

12. The subject is likely to be a recipient of tissue or organ transplantation.

13. Current history of alcohol or substance abuse or has a history of alcohol orsubstance abuse that required treatment within the previous 12 months.

14. History of poor compliance or unreliability.

15. Females who are pregnant, nursing, or planning a pregnancy during theirparticipation in the study.

16. Concurrent participation in another investigational drug, biologic or device studythat could confound study data.