Using Autologous Platelet Rich Plasma (PRP) Gel to Treat Deep 2nd and 3rd Degree Burns

The goal of this study is to demonstrate the safety of the application of autologous platelet
rich plasma (PRP) gel following excision and autologous skin grafting of acute deep 2nd and
3rd degree burns. This treatment is intended to stimulate rapid healing and improve the
outcome of standard of care treatments for burns common to active duty military personnel,
and more broadly for treatment of all acute burns. The care is specific to excision and split
thickness skin grafting in the context of this burn study. The study will enroll 42 patients
receiving surgical management of acute 2nd and 3rd degree burns requiring excision and skin
grafting. The patient's total body surface area burn injury should not exceed 20%. The study
will be conducted for 12 months. This study will provide further information for the
development of enhanced treatment of wound-deployable cellular therapy for advanced trauma
care of burned warriors.

Inclusion Criteria:

- Written informed consent obtained either the subject or the subject's legally
acceptable representative prior to screening activities

- Male or female age ≥ 18 and ≤ 86 years of age

- Total burn wound measuring ≤ 20% TBSA to include a deep partial thickness/full
thickness area requiring surgical excision and autologous split thickness skin grafts

- Hemoglobin HbA1c ≤7.5% (for patients with pre-existing diabetes mellitus)

- Able and willing to comply with the procedures required by the protocol. Patients may
be managed as either inpatient or outpatient.

- If a female of childbearing potential, the subject must have a negative serum
pregnancy test at screening

- All participants, male and female, must use acceptable method(s) of birth control for
the duration of the study

- Female subjects must be of non-childbearing potential (defined as postmenopausal for
at least 1 year or surgically sterile [bilateral tubal ligation, bilateral
oophorectomy or hysterectomy]) or must be using adequate contraception (practicing one
of the following methods of birth control):

- Total abstinence from sexual intercourse (minimum of one complete menstrual cycle
before study entry),

- A partner who is physically unable to impregnate the subject (e.g., vasectomized)

- Contraceptives (oral, parenteral, or transdermal) for 3 consecutive months prior to
the patient's cell concentrate administration,

- Intrauterine device (IUD)or,

- Double-barrier method (condoms, sponge, diaphragm, or vaginal ring with spermicidal
jellies or cream)

Exclusion Criteria:

- Conductive electrical burns and chemical burns

- Digits, head, genitalia, palms of hands, soles of feet, and face are excluded as test
sites

- Burns that pose a risk to digits or limbs

- Test area with infection as determined clinically by the investigator prior to surgery

- Venous or arterial vascular disorder directly affecting a designated test area

- Known immune deficiency disorder, either congenital or acquired

- Chronically malnourished as determined clinically by the investigator prior to surgery
(Investigators are responsible for determining subjects are chronically malnourished
during the screening process. Investigators should take into consideration the
following parameters: medical history and physical appearance, the subject's body mass
index, and any significant laboratory findings)

- Severe respiratory problems or concurrent head trauma at hospital admission, including
inhalation injury requiring ventilatory support

- Any chronic condition requiring the use of systemic corticosteroids 30 days prior to
study entry and anytime during the course of the study

- Any other acute or chronic concurrent medical condition(s) that in the investigator's
opinion are a contraindication to skin grafting and study participation or limit the
participant's life expectancy to < 6 months

- Known or suspected hypersensitivity to bovine protein

- Concurrent participation in another clinical trial in which an investigational agent
is used. (Subjects must not have been enrolled in another clinical trial within 30
days of enrolling in this trial)

- Females who are pregnant or nursing or intend to become pregnant during the duration
of the study

- Burn wounds that occur over joints

- Patients with the following abnormal laboratory test levels:

- Stage 4 or greater chronic kidney disease (eGFR < 30 mL/min)

- Hemoglobin < 10 g/dL

- Thrombocytopenia < 100,000 platelets/µL

- Serum albumin level <2.5 g/dL or > 30 g/dL at time of screening