Clinical grade human embryonic stem cells: derivation and characterization

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00216224%3A14110%2F19%3A00108560" target="_blank" >RIV/00216224:14110/19:00108560 - isvavai.cz</a>

Result on the web

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DOI - Digital Object Identifier

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Result language

angličtina

Original language name

Clinical grade human embryonic stem cells: derivation and characterization

Original language description

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).

Czech name

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Czech description

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Type

O - Miscellaneous

CEP classification

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OECD FORD branch

10601 - Cell biology

Project

<a href="/en/project/NV18-08-00412" target="_blank" >NV18-08-00412: Clinical grade human embryonic stem cells: derivation and characterization</a><br>

Continuities

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year

2019

Confidentiality

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů