Clinical trial NCT02169362: Applying Platelet Rich Plasma (PRP) Gel to Acute Deep Partial Thickness Thermal Injuries
Official title: Phase I, Double-Blind, Randomized, Controlled Study to Demonstrate the Safety of Applying Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™) to Acute Deep Partial Thickness Thermal Injuries
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Deep Partial Thickness Thermal Burns
Keywords: Burns
Thermal burns
Second degree burns
Partial thickness burns
Deep partial thickness burns
Acute burns
Burn wounds
Lead sponsor: Arteriocyte, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Department of Health and Human Services
First posted: 2014-06-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 86
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will examine the safety of using a concentration of proteins from a patient's own blood, referred to as platelet rich plasma or (PRP) and applying it to a second degree burn wound.

Detailed description: The objective of this trial is to demonstrate the safety of applying autologous PRP gel (Magellan® Bio-Bandage™) to acute deep partial thickness thermal burns in the first days after burn injury.

The Magellan® Bio-Bandage™ Burn Wound Care Kit is intended for the preparation and application of an autologous biological covering to deep partial thickness burn wounds to delay or minimize skin grafting requirements.

Eligibility criteria: Inclusion Criteria:

* Informed consent will be obtained prior to study participation
* Male or female age ≥ 18 years of age or ≤ 86 years of age
* Total burn wound measuring ≤ 25% TBSA
* Burn wound area to be treated must be a deep partial thickness wound
* Burn wound area to be treated must be ≤72 cm2 and surrounded by a perimeter of healthy skin
* Able and willing to comply with the procedures required by the protocol. Subjects 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 subjects, 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 subject'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, friction or chemical burns
* Burns to the digits, head, genitalia, palms of hands, soles of feet, and face that are the only possible sites for treatment (subjects with burns elsewhere in addition to these sites may be enrolled in the study)
* Burns that pose a risk to digits or limbs
* Subjects who have gone into hemorrhagic shock following burn injury
* Subject was medically treated for insulin-dependent or non-insulin-dependent diabetes mellitus prior to burn injury per subject medical history
* 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. (Investigators are responsible for determining if 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 ventilator support
* Any chronic condition requiring the use of systemic corticosteroids 30 days prior to study entry and anytime during the course of the study
* Use of COX-1 and/or COX-2 inhibitors within 48 hours prior to treatment. Subjects must refrain from use of NSAIDs for five days after Visit 2.
* Any other acute or chronic concurrent medical condition(s) that, in the investigator's opinion, are a contraindication to study participation or limit the subject's life expectancy to \< 6 months
* Known or suspected hypersensitivity to Recothrom®
* 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
* Known allergies to silver, adhesive products or silicone.
* Subjects 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
* Liver function\*:
* AST- Males and Females, \>2.5 ULN
* ALT- Males and Females, \>2.5 ULN
* Alkaline Phosphatase- Males and Females: \>2.0 ULN
* Total bilirubin- Males and Females \>2.0 ULN

Primary outcomes:
measure: Safety as measured by Adverse Events
timeFrame: Days 1 -365
Secondary outcomes:
measure: Delay or minimization of skin grafting requirements following burn injury
timeFrame: Change will be assessed up to 35 Days
measure: Improved wound healing trajectory as compared to standard of care
timeFrame: Change will be assessed up to 365 Days
measure: Increased rate of wound closure as compared to standard of care
timeFrame: Change will be assessed up to 365 Days
measure: Reduced scarring, pain and pruritus
timeFrame: Change will be assessed up to 365 Days
measure: Improved Skin-Healing Quality
timeFrame: Change will be assessed up to 365 Days
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Burn Center
state: Arizona
city: Sacramento
country: United States
facility: University of California, Davis Medica Center
state: California
city: Washington
country: United States
facility: MedStar Health Research Institute
state: District of Columbia
city: Tampa
country: United States
facility: Tampa General Hospital/University of South Florida
state: Florida
city: Las Vegas
country: United States
facility: University Medical Center Southern Nevada, Lions Regional Burn Center
state: Nevada
city: Chapel Hill
country: United States
facility: Jaycee Burn Center at University of North Carolina
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Memphis
country: United States
facility: Firefighters' Regional Burn Center
state: Tennessee
Study officials:
affiliation: Arteriocyte, Inc.
name: Brian Barnes, PhD
role: STUDY_DIRECTOR
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