Background: This study presents preliminary results concerning the effectiveness of a novel immunotherapy in cancer. The proposed adoptive cellular therapy product contains a mixture of effector immune cells, specifically macrophages, NK cells, dendritic cells, cytotoxic T lymphocytes and monoclonal antibody producing plasma cells.
Methods: The results were based on both descriptive and inferential statistical analysis of data concerning 17 cancer patients. Particularly, performance scales such as clinical condition, Karnofsky-Index, ECOG index and symptom's scale were evaluated post therapy administration (4 months). Furthermore, circulating tumor cells (CTCs) and a specific tumor marker (EpCAM) were measured pre- and post-cellular therapy.
Results: The results revealed a positive evaluation for clinical condition (70.59 %), Karnofsky-Index (88.23 %), ECOG index (94.12 %), and symptoms' scale (64.70 %). In addition, statistically significant reductions were found for both CTCs (p = 0.0016) and EpCAM positive cells (p = 0.0005), post-therapy, which were related to large size effects, namely 0.77 and 0.85, respectively. No cytokine storm, anaphylaxis or severe adverse events were observed with 4 months follow up evaluation.
Conclusions: These preliminary results indicate that the proposed cellular therapy can be considered for further studies in clinical trials.
Keywords: Autologous Therapy; Cancer; Cellular Therapy; Immune Cells; Immunotherapy.
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