Detailed Information on Publication Record
2019
Clinical grade human embryonic stem cells: derivation and characterization
SOURALOVÁ, Tereza, Aleš HAMPL, Irena KOUTNÁ and Pavel VENTRUBABasic information
Original name
Clinical grade human embryonic stem cells: derivation and characterization
Name in Czech
Lidské embryonální kmenové buňky v klinické kvalitě: derivace a charakterizace
Authors
SOURALOVÁ, Tereza (203 Czech Republic, guarantor, belonging to the institution), Aleš HAMPL (203 Czech Republic, belonging to the institution), Irena KOUTNÁ (203 Czech Republic, belonging to the institution) and Pavel VENTRUBA (203 Czech Republic)
Edition
29. sympozium asistované reprodukce a 18. česko-slovenská konference reprodukční gynekologie, Brno, Czech Republic, 2019
Other information
Language
English
Type of outcome
Konferenční abstrakt
Field of Study
10601 Cell biology
Country of publisher
Czech Republic
Confidentiality degree
není předmětem státního či obchodního tajemství
RIV identification code
RIV/00216224:14110/19:00108560
Organization unit
Faculty of Medicine
Keywords (in Czech)
hESCs; klinická kvalita; derivace
Keywords in English
hESCs; clinical-grade; derivation
Tags
Změněno: 31/5/2023 12:54, Mgr. Tereza Souralová
Abstract
V originále
Human embryonic stem cells (hESCs) are pluripotent and have unlimited capacity for self-renewal. These properties are used in stem-cell-based therapies to create missing or damaged cells in a human body. Derivation of hESCs has to be performed according to laws of the country of origin. In the case of the Czech Republic and European Union, there has to be signed informed consent by both donors for all donated discarded embryos that are not suitable for in vitro fertilization (IVF) treatment (directive 2004/23/EC). The mechanical biopsy of inner cell mass of 5-7 days-old blastocyst should be done by trained personnel in a very short time without transfer of trophoblast cells. We decided to expand hESCs in xeno-free environment including specific substrates (Biolaminin 521 CTG, CTSTM Vitronectin) and media (Nutristem® hPSC XF) in clinical-grade quality. Produced hESC line in clinical-grade quality has to fulfill specified criteria of safety, stability, pluripotency, identity, and ability to differentiate. In our project the safety is confirmed by a set of tests: detection of endogenous viruses, detection of Mycoplasma contamination a determination of endotoxin level. For testing the stability, a karyotyping is used. The pluripotency is analyzed by detection of specific markers by flow cytometry, immunocytochemistry and alkaline phosphatase assay. The identity is confirmed by the creation of STR profile and HLA haplotype. The differentiation ability is tested by embryoid bodies assay. We are going to establish at least 3 hESC lines in clinical grade quality in the xeno-free environment according to current good manufacturing practices (cGMP) immediately applicable in pre-clinical and clinical trials. hESC lines in this quality will be established for the first time in the Czech Republic and will respect all the criteria applicable for the Advanced Medicinal Therapy Products (ATMPs).
Links
| NV18-08-00412, research and development project |
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