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ST266 Versus Standard Care In Treating Partial Thickness Burns

9 de mayo de 2019 actualizado por: Noveome Biotherapeutics, formerly Stemnion

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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

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:

  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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

16

Fase

  • Fase 2
  • Fase 1

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Alabama
      • Mobile, Alabama, Estados Unidos, 36617
        • University of South Alabama Dept. of Surgery
    • California
      • Los Angeles, California, Estados Unidos, 90033
        • LAC - USC Medical Center
    • Florida
      • Gainesville, Florida, Estados Unidos, 32610
        • Shands Burn Center at the University of Florida
      • Tampa, Florida, Estados Unidos, 33606
        • University of South Florida / Tampa General Hospital
    • Illinois
      • Maywood, Illinois, Estados Unidos, 60153
        • Loyola University Medical Center
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40536-0284
        • University of Kentucky Chandler Medical Center
    • Maryland
      • Baltimore, Maryland, Estados Unidos, 21224
        • Johns Hopkins Burn Center
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Brigham and Women's Hospital
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65212
        • University of Missouri Health Care
      • Saint Louis, Missouri, Estados Unidos, 63110
        • Acute & Critical Care Surgery Barnes Jewish Hospital, Washington University Medical Center
    • New York
      • Rochester, New York, Estados Unidos, 14642
        • University of Rochester
    • Ohio
      • Cleveland, Ohio, Estados Unidos, 44109
        • MetroHealth Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15224
        • Western Pennsylvania Hospital
    • Texas
      • Houston, Texas, Estados Unidos, 77030
        • John S. Dunn Sr. Burn Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

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

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿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
Experimental: ST266 1
Topical treatment every other 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.
Experimental: ST266 2
Topical treatment every 4th 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.
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.

¿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
21 days

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
21 days
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
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
Periodo de tiempo: 21 days
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
Periodo de tiempo: 21 days
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
Periodo de tiempo: 21 days
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
Periodo de tiempo: 21 days
21 days
The primary safety endpoint will be the incidence of adverse events post-treatment.
Periodo de tiempo: 12 months
12 months

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Director de estudio: David L Steed, MD, Noveome Biotherapeutics, formerly Stemnion

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de junio de 2009

Finalización primaria (Actual)

1 de marzo de 2010

Finalización del estudio (Actual)

1 de marzo de 2010

Fechas de registro del estudio

Enviado por primera vez

22 de abril de 2009

Primero enviado que cumplió con los criterios de control de calidad

22 de abril de 2009

Publicado por primera vez (Estimar)

23 de abril de 2009

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de mayo de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

9 de mayo de 2019

Última verificación

1 de mayo de 2019

Más información

Términos relacionados con este estudio

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. .

Ensayos clínicos sobre ST266

3
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