Study Stopped
This study was terminated early due to slow accrual of patients.
ST266 Versus Standard Care In Treating Partial Thickness Burns
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
1 other identifier
interventional
16
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2009
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2009
CompletedFirst Posted
Study publicly available on registry
April 23, 2009
CompletedStudy Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedMay 15, 2019
May 1, 2019
9 months
April 22, 2009
May 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
21 days
Secondary Outcomes (7)
The number of totally epithelialized (100%) wounds in the ST266-treated wounds versus the number in the normal saline-treated wounds
21 days
The percentage conversion to full-thickness wounds in the ST266-treated wounds versus the conversion in the normal saline-treated wounds
21 days
Quality of healing, including pruritis, and scar hypertrophy, and reduction in pain in the ST266-treated wounds as compared to saline-treated wounds
21 days
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
21 days
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
21 days
- +2 more secondary outcomes
Study Arms (3)
ST266 1
EXPERIMENTALTopical treatment every other day
ST266 2
EXPERIMENTALTopical treatment every 4th day
ST266 3
EXPERIMENTALTopical treatment every 7th day
Interventions
ST266 is a clear liquid containing more than 200 proteins, cytokines, and growth factors in solution. Patients will be treated for 21 days unless both wounds have healed prior to 21 days, at which time a punch biopsy of the epithelialized area of each wound will be performed. A study evaluation visit for assessment of the biopsy site will occur on day 28 or within 7 days of the punch biopsies, whichever occurs first. Six months after the punch biopsy, the patient will return to the burn center for a final examination and photographs of the study wounds.
Eligibility Criteria
You may qualify if:
- A signed IRB (Institutional Review Board)- approved Informed Consent Form;
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
University of South Alabama Dept. of Surgery
Mobile, Alabama, 36617, United States
LAC - USC Medical Center
Los Angeles, California, 90033, United States
Shands Burn Center at the University of Florida
Gainesville, Florida, 32610, United States
University of South Florida / Tampa General Hospital
Tampa, Florida, 33606, United States
Loyola University Medical Center
Maywood, Illinois, 60153, United States
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0284, United States
Johns Hopkins Burn Center
Baltimore, Maryland, 21224, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
University of Missouri Health Care
Columbia, Missouri, 65212, United States
Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
St Louis, Missouri, 63110, United States
University of Rochester
Rochester, New York, 14642, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224, United States
John S. Dunn Sr. Burn Center
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David L Steed, MD
Noveome Biotherapeutics, formerly Stemnion
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2009
First Posted
April 23, 2009
Study Start
June 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
May 15, 2019
Record last verified: 2019-05