Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Female/male patients, aged 20-65 years old
Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2 but no more than 100 cm2, with a minimum width of 3 cm and with an approximate thickness of 0.010~0.012 inches. The graft cannot be harvested from a site from which a skin graft was previously obtained.
If the primary wound is a result of a thermal or chemical burn, the total body surface area of the said wound must be less than 15%.
Females of childbearing potential must have a documented negative serum pregnancy test done at the screening visit, which is within 2 weeks prior the DSW creation and the treatment
Both male and female patients must agree to use highly effective contraceptives from signing informed consent to 30 days after the last dose administration.
Willing to comply with the study protocol and to sign the Informed Consent Form

Exclusion Criteria:

Female patients who are pregnant or lactating or planning a pregnancy and any male patient whose partner (wife) planning a pregnancy from signing informed consent to 30 days after the last dose administration.
Clinically significant disease or condition that may compromise graft take and/or donor site healing (e.g. the presence of a bleeding disorder, capillary fragility, venous or arterial disorder directly affecting the donor site to be treated, known or suspected systemic malignancies, human immunodeficiency virus infection, renal or liver disease, uncontrolled diabetes mellitus, thrombocytopenia, vasculitis, poor nutritional status).

Patients who are currently receiving or have received the following treatments within 4 weeks prior to study entry are excluded from the study:

systemic or inhaled corticosteroids or immunosuppressant agents; or
therapeutic doses of anticoagulants (e.g. Coumadin, Heparin, low molecular weight Heparin) for pre-existing medical conditions, for whom a dose interruption from Screening through the end of the study period is contraindicated.
Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
Hematologic disease, malignancy or hypo-immunity.
History of HIV or congenital immunodeficiency.
History of alcoholism or drug abuse.
Have used any tobacco product within 1 week prior to Day 0.
Patients previously treated with any cell-based product, including autologous tissue at the treatment site.
Received an investigational drug, device or biological/bioactive treatment within 30 days prior to Screening Visit.
Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the trial treatment.
History of sensitivity to bovine or porcine origin materials, or human serum albumin.
DSWs located in the face, over joints, lower legs or the buttocks
Any of the following hematologic abnormalities: (Hemoglobin < 10.0 g/dL, ANC < 1,500/μL, platelets < 75,000 /μL)
Any of the following serum chemistry abnormalities: (Total bilirubin > 1.5 × ULN, AST or ALT > 3 × ULN, gamma-GT > 2.5 x ULN, Alk-P > 2.5 x ULN, serum albumin < 2.7 g/dL, creatinine >1.5 x ULN, any other ≥ Grade 2 laboratory abnormality (based on CTCAE) at baseline (other than those listed above)
DSWs in area with active skin infection or with skin condition that is considered highly susceptible to infection judged by the investigator