Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

ST266 Versus Standard Care In Treating Partial Thickness Burns

9. Mai 2019 aktualisiert von: 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.

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

16

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: ST266 1
Topical treatment every other day
Biologisch: ST266
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
Biologisch: ST266
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
Biologisch: ST266
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
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.
Zeitfenster: 21 days
21 days

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
The number of totally epithelialized (100%) wounds in the ST266-treated wounds versus the number in the normal saline-treated wounds
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 21 days
21 days
The primary safety endpoint will be the incidence of adverse events post-treatment.
Zeitfenster: 12 months
12 months

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Noveome Biotherapeutics, formerly Stemnion

Ermittler

  • Studienleiter: David L Steed, MD, Noveome Biotherapeutics, formerly Stemnion

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2009

Primärer Abschluss (Tatsächlich)

1. März 2010

Studienabschluss (Tatsächlich)

1. März 2010

Studienanmeldedaten

Zuerst eingereicht

22. April 2009

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

22. April 2009

Zuerst gepostet (Schätzen)

23. April 2009

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

15. Mai 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

9. Mai 2019

Zuletzt verifiziert

1. Mai 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ACCS-PT-09.001

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren