Clinical grade human embryonic stem cells: derivation and
characterization

a 2019

Clinical grade human embryonic stem cells: derivation and characterization

SOURALOVÁ, Tereza; Aleš HAMPL; Irena KOUTNÁ a Pavel VENTRUBA

Základní údaje

Originální název

Clinical grade human embryonic stem cells: derivation and characterization

Název česky

Lidské embryonální kmenové buňky v klinické kvalitě: derivace a charakterizace

Autoři

SOURALOVÁ, Tereza (203 Česká republika, garant, domácí); Aleš HAMPL (203 Česká republika, domácí); Irena KOUTNÁ (203 Česká republika, domácí) a Pavel VENTRUBA (203 Česká republika)

Vydání

29. sympozium asistované reprodukce a 18. česko-slovenská konference reprodukční gynekologie, Brno, Czech Republic, 2019

Další údaje

Jazyk

angličtina

Typ výsledku

Konferenční abstrakt

Obor

10601 Cell biology

Stát vydavatele

Česká republika

Utajení

není předmětem státního či obchodního tajemství

Kód RIV

RIV/00216224:14110/19:00108560

Organizační jednotka

Lékařská fakulta

Klíčová slova česky

hESCs; klinická kvalita; derivace

Klíčová slova anglicky

hESCs; clinical-grade; derivation

Štítky

rivok

Změněno: 31. 5. 2023 12:54, Mgr. Tereza Souralová

Anotace

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).

Návaznosti

NV18-08-00412, projekt VaV

Název: Lidské embryonální kmenové buňky pro klinické aplikace: derivace a charakterizace

Investor: Ministerstvo zdravotnictví ČR, Lidské embryonální kmenové buňky pro klinické aplikace: derivace a charakterizace

Citovat

SOURALOVÁ, Tereza; Aleš HAMPL; Irena KOUTNÁ a Pavel VENTRUBA. Clinical grade human embryonic stem cells: derivation and characterization. In 29. sympozium asistované reprodukce a 18. česko-slovenská konference reprodukční gynekologie, Brno, Czech Republic. 2019.

@proceedings{1599656,
   author = {Souralová, Tereza and Hampl, Aleš and Koutná, Irena and Ventruba, Pavel},
   booktitle = {29. sympozium asistované reprodukce a 18. česko-slovenská konference reprodukční gynekologie, Brno, Czech Republic},
   keywords = {hESCs; clinical-grade; derivation},
   language = {eng},
   title = {Clinical grade human embryonic stem cells: derivation and characterization},
   year = {2019}
}

TY  - CONF
ID  - 1599656
AU  - Souralová, Tereza - Hampl, Aleš - Koutná, Irena - Ventruba, Pavel
PY  - 2019
TI  - Clinical grade human embryonic stem cells: derivation and characterization
KW  - hESCs
KW  - clinical-grade
KW  - derivation
N2  - 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).
ER  -

SOURALOVÁ, Tereza; Aleš HAMPL; Irena KOUTNÁ a Pavel VENTRUBA. Clinical grade human embryonic stem cells: derivation and characterization. In \textit{29. sympozium asistované reprodukce a 18. česko-slovenská konference reprodukční gynekologie, Brno, Czech Republic}. 2019.

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