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ST266 Versus Standard Care In Treating Partial Thickness Burns

9 maggio 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Terminato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Effettivo)

16

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ST266 1
Topical treatment every other day
Biologico: 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.
Sperimentale: ST266 2
Topical treatment every 4th day
Biologico: 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.
Sperimentale: ST266 3
Topical treatment every 7th day
Biologico: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Lasso di tempo
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.
Lasso di tempo: 21 days
21 days

Misure di risultato secondarie

Misura del risultato
Lasso di tempo
The number of totally epithelialized (100%) wounds in the ST266-treated wounds versus the number in the normal saline-treated wounds
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 21 days
21 days
The primary safety endpoint will be the incidence of adverse events post-treatment.
Lasso di tempo: 12 months
12 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Noveome Biotherapeutics, formerly Stemnion

Investigatori

  • Direttore dello studio: David L Steed, MD, Noveome Biotherapeutics, formerly Stemnion

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2009

Completamento primario (Effettivo)

1 marzo 2010

Completamento dello studio (Effettivo)

1 marzo 2010

Date di iscrizione allo studio

Primo inviato

22 aprile 2009

Primo inviato che soddisfa i criteri di controllo qualità

22 aprile 2009

Primo Inserito (Stima)

23 aprile 2009

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 maggio 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

9 maggio 2019

Ultimo verificato

1 maggio 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ACCS-PT-09.001

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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