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.
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.
Authors: S Nahum Goldberg; Clement J Grassi; John F Cardella; J William Charboneau; Gerald D Dodd; Damian E Dupuy; Debra Gervais; Alice R Gillams; Robert A Kane; Fred T Lee; Tito Livraghi; John McGahan; David A Phillips; Hyunchul Rhim; Stuart G Silverman Journal: J Vasc Interv Radiol Date: 2005-06 Impact factor: 3.464
Authors: Vindhya Palagani; Mona El Khatib; Uta Kossatz; Przemyslaw Bozko; Martin R Müller; Michael P Manns; Till Krech; Nisar P Malek; Ruben R Plentz Journal: PLoS One Date: 2012-10-19 Impact factor: 3.240
Authors: Ravindra Majeti; Mark P Chao; Ash A Alizadeh; Wendy W Pang; Siddhartha Jaiswal; Kenneth D Gibbs; Nico van Rooijen; Irving L Weissman Journal: Cell Date: 2009-07-23 Impact factor: 41.582