Clinical trial NCT00886470: ST266 Versus Standard Care In Treating Partial Thickness Burns
Official title: Phase I/II Randomized Blinded Safety, Dose-determining Efficacy Trial Comparing Amnion-derived Cellular Cytokine Solution in 3 Different Regimens With Standard Care 0.9% Sodium Chloride in the Topical Treatment of Partial-thickness Burns
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Burns
Keywords: cytokines
pain
scarring
vascularity
Lead sponsor: Noveome Biotherapeutics, formerly Stemnion
Sponsor class: INDUSTRY
First posted: 2009-04-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this protocol is to perform a safety and dose-determination efficacy clinical trial in patients having a degree of partial-thickness burn wounds. The trial will be a prospectively randomized and double-blind trial of ST266 compared with standardized care using 0.9% NaCl (normal saline) solution in the same three treatment regimens.

Detailed description: 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 ST266 or normal saline in one of three treatment regimens.

The three treatment arms will be:

1. ST266 0.01 mL/cm2 every 7th day vs. normal saline 0.01 mL/cm2 every 7th day;
2. ST266 0.01 mL/cm2 every 4th day vs. normal saline 0.01 mL/cm2 every 4th day; and
3. ST266 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 ST266. 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 ST266 treatment.

In the preclinical studies, ST266 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The primary endpoint will be the percentage of each wound that has epithelialized during the 21-day treatment period comparing the ST266-treated wound with the saline-treated wound.
timeFrame: 21 days
Secondary outcomes:
measure: The number of totally epithelialized (100%) wounds in the ST266-treated wounds versus the number in the normal saline-treated wounds
timeFrame: 21 days
measure: The percentage conversion to full-thickness wounds in the ST266-treated wounds versus the conversion in the normal saline-treated wounds
timeFrame: 21 days
measure: Quality of healing, including pruritis, and scar hypertrophy, and reduction in pain in the ST266-treated wounds as compared to saline-treated wounds
timeFrame: 21 days
measure: Quality of healing as assessed by hemoxylin and eosin staining of the punch biopsy taken on Day 21 in the ST266-treated wounds as compared to saline-treated wounds
timeFrame: 21 days
measure: Assessment of change in arterial circulation using a laser Doppler from baseline to Day 21 in the ST266-treated wounds as compared to saline-treated wounds
timeFrame: 21 days
measure: Determination of levels of 6 cytokines present in blood prior to treatment (baseline) and within one-hour of the first treatment for the initial 12 patients
timeFrame: 21 days
measure: The primary safety endpoint will be the incidence of adverse events post-treatment.
timeFrame: 12 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama Dept. of Surgery
state: Alabama
city: Los Angeles
country: United States
facility: LAC - USC Medical Center
state: California
city: Gainesville
country: United States
facility: Shands Burn Center at the University of Florida
state: Florida
city: Tampa
country: United States
facility: University of South Florida / Tampa General Hospital
state: Florida
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Burn Center
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Columbia
country: United States
facility: University of Missouri Health Care
state: Missouri
city: Saint Louis
country: United States
facility: Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
state: Missouri
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Pittsburgh
country: United States
facility: Western Pennsylvania Hospital
state: Pennsylvania
city: Houston
country: United States
facility: John S. Dunn Sr. Burn Center
state: Texas
Study officials:
affiliation: Noveome Biotherapeutics, formerly Stemnion
name: David L Steed, MD
role: STUDY_DIRECTOR
References: