Prospective study of the safety and efficacy of a pancreatic cancer stem cell vaccine.
J Cancer Res Clin Oncol
; 141(10): 1827-33, 2015 Oct.
Article
en En
| MEDLINE
| ID: mdl-25860618
INTRODUCTION: In this trial, we isolated and cultured pancreatic cancer stem cells (CSCs) to produce a vaccine and prospectively evaluated its safety and efficacy in low-, medium-, and high-dose groups. MATERIAL AND METHODS: Between February and October 2014, we enrolled 90 patients who met the enrollment criteria and assigned them to three groups (n = 30). CSC-specific and CSC-non-specific immunity pre- and post-vaccination were compared by Dunnett's multiple comparison test (one-way ANOVA). The data are presented as the mean±standard deviation. Local and systemic adverse events were recorded in the nursing records and compared using the Chi-square test. All statistical analyses were conducted using GraphPad software (GraphPad, San Diego, CA, USA). RESULTS: Throughout the trial, an injection site reaction was the most common reaction (54 %), and fever was least common (9 %). The incidence of these side effects did not vary among the three groups. When the pre- and post-vaccination immunity was compared, we found that both CSC-nonspecific and CSC-specific responses were significantly increased in the high-dose group. CONCLUSION: This study is the first clinical trial of a pancreatic CSC vaccine and preliminarily proves its safety and efficacy.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Neoplasias Pancreáticas
/
Células Madre Neoplásicas
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Vacunas
/
Inmunidad
Tipo de estudio:
Observational_studies
Límite:
Female
/
Humans
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Male
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Middle aged
Idioma:
En
Revista:
J Cancer Res Clin Oncol
Año:
2015
Tipo del documento:
Article
País de afiliación:
China
Pais de publicación:
Alemania