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J Cancer Res Clin Oncol ; 141(10): 1827-33, 2015 Oct.
Article in English | MEDLINE | ID: mdl-25860618

ABSTRACT

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.


Subject(s)
Immunity/immunology , Neoplastic Stem Cells/immunology , Pancreatic Neoplasms/immunology , Vaccines/immunology , Female , Humans , Male , Middle Aged , Prospective Studies , Safety , Vaccination/methods
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