ACCS (Amnion-derived Cellular Cytokine Solution) Versus Standard Care In Treating Partial Thickness Burns

A Phase I/II multi-center clinical trial will be performed in 99 adults with
partial-thickness burns. Two similar partial-thickness burn areas in a single patient will
be selected. One burn will be randomly assigned to receive either test drug (ACCS) or normal
saline in one of three treatment regimens.

The three treatment arms will be:

1. ACCS 0.01 mL/cm2 every 7th day vs. normal saline 0.01 mL/cm2 every 7th day;

2. ACCS 0.01 mL/cm2 every 4th day vs. normal saline 0.01 mL/cm2 every 4th day; and

3. ACCS 0.01 mL/cm2 every other day vs. normal saline 0.01 mL/cm2 every other day.

Two different preclinical studies of partial-thickness burns on guinea pigs have
demonstrated accelerated epithelialization with topical treatment with ACCS. Similarly,
preclinical studies in Yorkshire pigs have demonstrated more rapid maturity of
epithelialization and better quality healing of partial-thickness skin graft donor sites
with ACCS treatment.

In the preclinical studies, ACCS given in a dose of 0.01 mL/cm2 wound area appeared to
saturate the wound adequately without excess and simultaneously improve healing. In
preclinical toxicity studies, the dose of 0.01 mL/cm2 was shown to be safe.

Inclusion Criteria:

- A signed IRB (Institutional Review Board)- approved Informed Consent Form;

- 18 - 65 years of age;

- Two (2) similar, non-contiguous, partial-thickness burn wounds between 50 cm2 and 250
cm2 in area with blisters removed in a Total Body Surface Area(TBSA) burn of less
than or equal to 40% TBSA;

- Burns must be thermal burns of flame or scald etiology;

- Patient must present to the burn center within 8 hours of injury;

- Normal creatinine and bilirubin levels;

- If capable of bearing children, patient must be using a medically accepted means of
birth control and have a negative serum pregnancy test;

- Willing to participate in the clinical study and comply with the requirements of the
trial.

Exclusion Criteria:

- The two (2) chosen wounds must not be full-thickness (extending through the dermis
into the subcutaneous tissue);

- Thermal burn from chemical, electrical or radiation causes;

- Neither the study wound nor the comparator wound can be < 50 cm2 or >250 cm2 in size
and cannot be on the face or hands;

- Patients with significant pulmonary injury, i.e., smoke inhalation injury requiring
ventilator support;

- Patients with diabetes;

- Patients with any immune deficiency including current treatment with corticosteroid
medication, chemotherapeutic agents, anti-viral therapy, or concurrent radiation
therapy within 30 days of signing the informed consent;

- Abnormal bilirubin, liver function studies (i.e., Alanine transaminase (ALT);
Aspartate transaminase (AST)> 2.0 times normal);

- Abnormal serum creatinine, receiving hemodialysis or peritoneal dialysis;

- Active cancer or a history of cancer in the 5 years prior to signing the informed
consent form (history of basal cell carcinoma is allowed);

- Psychiatric condition or substance abuse which in the Investigator's opinion may pose
a threat to patient compliance;

- History of non-compliance with treatment or clinical visit attendance.

- Patients whose burns were previously treated with anything other than ice, cold water
or dry dressing.

- Participation in an investigational trial within 30 days of study entry.