Back to resultsST266 Versus Standard Care In Treating Partial Thickness Burns
Primary Purpose
Burns
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ST266
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring cytokines, pain, scarring, vascularity
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.
Sites / Locations
- University of South Alabama Dept. of Surgery
- LAC - USC Medical Center
- Shands Burn Center at the University of Florida
- University of South Florida / Tampa General Hospital
- Loyola University Medical Center
- University of Kentucky Chandler Medical Center
- Johns Hopkins Burn Center
- Brigham and Women's Hospital
- University of Missouri Health Care
- Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
- University of Rochester
- MetroHealth Medical Center
- Western Pennsylvania Hospital
- John S. Dunn Sr. Burn Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
ST266 1
ST266 2
ST266 3
Arm Description
Topical treatment every other day
Topical treatment every 4th day
Topical treatment every 7th day
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The number of totally epithelialized (100%) wounds in the ST266-treated wounds versus the number in the normal saline-treated wounds
The percentage conversion to full-thickness wounds in the ST266-treated wounds versus the conversion in the normal saline-treated wounds
Quality of healing, including pruritis, and scar hypertrophy, and reduction in pain in the ST266-treated wounds as compared to saline-treated wounds
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
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
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
The primary safety endpoint will be the incidence of adverse events post-treatment.
Full Information
NCT ID
NCT00886470
First Posted
April 22, 2009
Last Updated
May 9, 2019
Sponsor
Noveome Biotherapeutics, formerly Stemnion
1. Study Identification
Unique Protocol Identification Number
NCT00886470
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated early due to slow accrual of patients.
Study Start Date
June 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Noveome Biotherapeutics, formerly Stemnion
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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:
ST266 0.01 mL/cm2 every 7th day vs. normal saline 0.01 mL/cm2 every 7th day;
ST266 0.01 mL/cm2 every 4th day vs. normal saline 0.01 mL/cm2 every 4th day; and
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
cytokines, pain, scarring, vascularity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ST266 1
Arm Type
Experimental
Arm Description
Topical treatment every other day
Arm Title
ST266 2
Arm Type
Experimental
Arm Description
Topical treatment every 4th day
Arm Title
ST266 3
Arm Type
Experimental
Arm Description
Topical treatment every 7th day
Intervention Type
Biological
Intervention Name(s)
ST266
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Time Frame
21 days
Secondary Outcome Measure Information:
Title
The number of totally epithelialized (100%) wounds in the ST266-treated wounds versus the number in the normal saline-treated wounds
Time Frame
21 days
Title
The percentage conversion to full-thickness wounds in the ST266-treated wounds versus the conversion in the normal saline-treated wounds
Time Frame
21 days
Title
Quality of healing, including pruritis, and scar hypertrophy, and reduction in pain in the ST266-treated wounds as compared to saline-treated wounds
Time Frame
21 days
Title
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
Time Frame
21 days
Title
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
Time Frame
21 days
Title
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
Time Frame
21 days
Title
The primary safety endpoint will be the incidence of adverse events post-treatment.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David L Steed, MD
Organizational Affiliation
Noveome Biotherapeutics, formerly Stemnion
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama Dept. of Surgery
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
LAC - USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Shands Burn Center at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of South Florida / Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
University of Kentucky Chandler Medical Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0284
Country
United States
Facility Name
Johns Hopkins Burn Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21224
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Missouri Health Care
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Western Pennsylvania Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
John S. Dunn Sr. Burn Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
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ST266 Versus Standard Care In Treating Partial Thickness Burns
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