BurnsPhase 1/2NCT00886470
ST266 Versus Standard Care In Treating Partial Thickness Burns
A Phase 1/2 study testing ST266 in people with Burns, run by Noveome Biotherapeutics, formerly Stemnion at 14 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns
- What is being tested?
- ST266
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 14 sitesUnited States
- Study dates
- Jun 2009to Mar 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Johns Hopkins Burn Center
Baltimore, Maryland, 21224
Brigham and Women's Hospital
Boston, Massachusetts, 02115
MetroHealth Medical Center
Cleveland, Ohio, 44109
University of Missouri Health Care
Columbia, Missouri, 65212
Shands Burn Center at the University of Florida
Gainesville, Florida, 32610
John S. Dunn Sr. Burn Center
Houston, Texas, 77030
University of Kentucky Chandler Medical Center
Lexington, Kentucky, 40536-0284
LAC - USC Medical Center
Los Angeles, California, 90033
Loyola University Medical Center
Maywood, Illinois, 60153
University of South Alabama Dept. of Surgery
Mobile, Alabama, 36617
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
University of Rochester
Rochester, New York, 14642
Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
St Louis, Missouri, 63110
University of South Florida / Tampa General Hospital
Tampa, Florida, 33606
About this study
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
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.
Read the 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.
- Conditions
- Burns
- Being tested
- ST266
- Keywords
- cytokines, pain, scarring, vascularity
- Medical subject headings
- Burns, Pain, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ST266Biological
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.
| Study group | Role | What they receive |
|---|---|---|
| ST266 1 | Experimental | Topical treatment every other day Receives: Biological: ST266 |
| ST266 2 | Experimental | Topical treatment every 4th day Receives: Biological: ST266 |
| ST266 3 | Experimental | Topical treatment every 7th day Receives: Biological: ST266 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 21 days
The percentage conversion to full-thickness wounds in the ST266-treated wounds versus the conversion in the normal saline-treated wounds
Measured: 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
Measured: 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
Measured: 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
Measured: 21 days
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
Measured: 21 days
The primary safety endpoint will be the incidence of adverse events post-treatment.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: This study was terminated early due to slow accrual of patients.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Noveome Biotherapeutics, formerly Stemnion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David L Steed, MD, Study director, Noveome Biotherapeutics, formerly Stemnion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886470
- Sponsor's protocol ID
- ACCS-PT-09.001
- Status last verified
- May 2019
- First submitted
- 22 Apr 2009
- Last updated
- 15 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00886470
- Acronym / sponsor ID
- ACCS-PT-09.001
- Conditions
- Burns
- Keywords
- cytokines, pain, scarring, vascularity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early due to slow accrual of patients.
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Noveome Biotherapeutics, formerly StemnionIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 23 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ST266 1 | Experimental | Biological: ST266Topical treatment every other day |
| ST266 2 | Experimental | Biological: ST266Topical treatment every 4th day |
| ST266 3 | Experimental | Biological: ST266Topical treatment every 7th day |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ST266ST266 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. | Biological | ST266 1, ST266 2, ST266 3 |
Primary outcome
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
7 secondary outcomes
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
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
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
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
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
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
The primary safety endpoint will be the incidence of adverse events post-treatment.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: This study was terminated early due to slow accrual of patients.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David L Steed, MD study director
Noveome Biotherapeutics, formerly Stemnion
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ST266 in people with Burns, run by Noveome Biotherapeutics, formerly Stemnion at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: This study was terminated early due to slow accrual of patients.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.