- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00886470
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
Descripción general del estudio
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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Alabama
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Mobile, Alabama, Estados Unidos, 36617
- University of South Alabama Dept. of Surgery
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California
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Los Angeles, California, Estados Unidos, 90033
- LAC - USC Medical Center
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Florida
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Gainesville, Florida, Estados Unidos, 32610
- Shands Burn Center at the University of Florida
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Tampa, Florida, Estados Unidos, 33606
- University of South Florida / Tampa General Hospital
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Illinois
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Maywood, Illinois, Estados Unidos, 60153
- Loyola University Medical Center
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40536-0284
- University of Kentucky Chandler Medical Center
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Maryland
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Baltimore, Maryland, Estados Unidos, 21224
- Johns Hopkins Burn Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
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Missouri
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Columbia, Missouri, Estados Unidos, 65212
- University of Missouri Health Care
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Saint Louis, Missouri, Estados Unidos, 63110
- Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
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New York
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Rochester, New York, Estados Unidos, 14642
- University of Rochester
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Ohio
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Cleveland, Ohio, Estados Unidos, 44109
- MetroHealth Medical Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15224
- Western Pennsylvania Hospital
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Texas
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Houston, Texas, Estados Unidos, 77030
- John S. Dunn Sr. Burn Center
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: ST266 1
Topical treatment every other day
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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.
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Experimental: ST266 2
Topical treatment every 4th day
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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.
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Experimental: ST266 3
Topical treatment every 7th day
|
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
---|---|
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.
Periodo de tiempo: 21 days
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21 days
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
---|---|
The number of totally epithelialized (100%) wounds in the ST266-treated wounds versus the number in the normal saline-treated wounds
Periodo de tiempo: 21 days
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21 days
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The percentage conversion to full-thickness wounds in the ST266-treated wounds versus the conversion in the normal saline-treated wounds
Periodo de tiempo: 21 days
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21 days
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Quality of healing, including pruritis, and scar hypertrophy, and reduction in pain in the ST266-treated wounds as compared to saline-treated wounds
Periodo de tiempo: 21 days
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21 days
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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
Periodo de tiempo: 21 days
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21 days
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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
Periodo de tiempo: 21 days
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21 days
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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
Periodo de tiempo: 21 days
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21 days
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The primary safety endpoint will be the incidence of adverse events post-treatment.
Periodo de tiempo: 12 months
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12 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: David L Steed, MD, Noveome Biotherapeutics, formerly Stemnion
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- ACCS-PT-09.001
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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