Safety and Feasibility of ADRCs Treatment To Patients With Thermal Wounds

The RELIEF Trial is a prospective, open-label, parallel group, usual care controlled,
multi-center randomized (2:1, active: usual care alone) safety and feasibility study
targeting thermal burns. Subjects will have at least one deep partial or full thickness burn
wounds of > 250 cm2 that is to be autografted with a split thickness meshed skin graft
(STSG). Subjects randomized to ADRCs will undergo small volume fat harvest (100 to 150 mL)
performed at initiation of general anesthesia for scheduled burn surgery followed by
intravenous delivery of ADRCs within 4 hours following surgery. The lipoaspirate will be
processed in the Celution® System to isolate and concentrate ADRCs.

Following informed consent and initial screening assessments, eligible subjects will undergo
pre-operative testing. On the procedure day, subjects will be randomized to ADRCs (with usual
care) or usual care alone. Low volume lipoharvest will only be performed on subjects
randomized to ADRCs in order to obtain 100-150 mL lipoaspirate, which will then be
transferred to the Celution® System for processing to isolate and concentrate ADRCs for
same-day administration. All treatment will be delivered in a total volume of 10 mL which
will be delivered by slow intravenous administration into a peripheral vein.

Following surgery, subjects will be evaluated at first dressing change, day 10 (±2) (only if
wound dressing change planned) and weeks 2 (±3 days), 3 (±3 days), 4 (±3 days), 8 (±7 days),
12 (±14 days), 26 (±14 days), and 52(±21 days).

The 1st 5 subjects enrolled in active treatment will be observed for adverse events over a 7
day period. If no SAEs occur during that period, for that individual subject, the next
subject enrolled in active treatment may be entered with the same 7 day observation period.
The safety results of the first 5 subjects will be reviewed by the DMC and their evaluation
will be used in conjunction with the clinical data collected to date, and if appropriate, to
potentially remove the staggering approach to the study. Enrollment after the first 5
subjects may continue only after the DMC has completed its safety review and recommends
continuation.

Inclusion Criteria:

- Males or females age ≥ 18 to ≤ 65

- BMI > 20 kg/m2

- Burn TBSA 20% - 50%

- At least one deep partial thickness and/or full thickness thermal burn ≥ 250 cm2 on
the arms, legs, back, abdomen or chest that is anticipated to be covered with
autologous meshed STSG meshed and that has not been treated previously with a biologic
dressing such as Alloderm® or Integra®

- Ability to safely undergo tissue harvest that is anticipated to yield >150mL of
adipose tissue at a site that is free from infection

- Donor site availability for skin graft harvest

- Able to provide written informed consent signed by either the patient or their legally
authorized representative

- Women and men of child-bearing potential agreeing to use contraception during the
study. Acceptable methods include surgical sterility, IUDs, hormonal contraception or
double barrier methods

Exclusion Criteria:

- Subjects with burns > 3rd degree (i.e. involvement of deeper tissues, such as muscle,
tendons, or bone)

- Subjects with electrical or chemical burns

- Subjects with significant inhalation injuries necessitating intubation and mechanical
ventilation or requiring > 50% FI02 on a continuous basis to maintain oxygenation (02
sat > 90%)

- In the opinion of treating physician, patient not expected to survive beyond 30 days

- Pre-existing condition requiring current use of immunosuppressive medication or
systemic steroids

- Pregnant or lactating status. Pregnancy as determined by a positive pregnancy test at
screening or baseline

- Known history of HIV infection, or active Hepatitis B or active Hepatitis C infection

- Cancer requiring chemotherapy or radiation within previous 6 months or resection
within the last 5 years (other than basal cell carcinoma)

- Known chronic renal failure (serum creatinine > 2 mg/dL) or chronic liver disease

- Pre-existing medical conditions that would interfere with wound healing (i.e.diabetic
patients with Hemoglobin A1c test result ≥8%, malignancy, autoimmune disease)

- Subjects with psychiatric conditions that are anticipated to result in protocol
noncompliance

- Chronic illicit drug or alcohol abuse that is anticipated to interfere with patient
compliance with the protocol

- Participation in another clinical trial within 60 days of the screening visit