Abstract
A phase I clinical trial is being currently performed in our institution, aiming at evaluating the feasibility and toxicity related to the administration of Herpes Simplex-thymidine kinase gene-expressing human primary T lymphocytes following allogeneic hematopoietic stem cell transplantation. The need for safe and standardized preparation conditions for gene-modified cells is crucial. We describe the closed culture system used in the current trial for ex vivo retroviral-mediated gene transfer and transduced cell selection. Cell handling is performed in closed systems using sampling and transfer pack bags, culture bags and a sterile connection device which avoids opening the culture system. This closed system allows safe and reproducible ex vivo preparation of gene-modified primary T-lymphocytes for clinical use.
Publication types
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Clinical Trial
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Clinical Trial, Phase I
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English Abstract
MeSH terms
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Cell Culture Techniques / instrumentation
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Cell Culture Techniques / methods*
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Cells, Cultured / transplantation
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Cells, Cultured / virology
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Centrifugation / methods
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Equipment Contamination / prevention & control
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Forms and Records Control
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Genetic Therapy / instrumentation
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Genetic Therapy / methods*
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Genetic Vectors / genetics*
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Hematopoietic Stem Cell Transplantation / instrumentation
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Hematopoietic Stem Cell Transplantation / methods*
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Hematopoietic Stem Cells / enzymology
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Hematopoietic Stem Cells / virology
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Humans
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Quality Control
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Safety
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Simplexvirus / enzymology
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Simplexvirus / genetics*
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Sterilization
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T-Lymphocytes / enzymology
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T-Lymphocytes / virology
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Thymidine Kinase / genetics*
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Viral Proteins / genetics*
Substances
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Viral Proteins
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Thymidine Kinase