The first ever effort to establish clinical grade human embryonic stem cells in the Czech Republic

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F65269705%3A_____%2F18%3A00069951" target="_blank" >RIV/65269705:_____/18:00069951 - isvavai.cz</a>

Výsledek na webu

<a href="http://www.ivfbrno.cz/28-sympozium-asistovane-reprodukce-a-17-cesko-slovenska-konference-reprodukcni-gynekologie/t1169" target="_blank" >http://www.ivfbrno.cz/28-sympozium-asistovane-reprodukce-a-17-cesko-slovenska-konference-reprodukcni-gynekologie/t1169</a>

DOI - Digital Object Identifier

—

Jazyk výsledku

angličtina

Název v původním jazyce

The first ever effort to establish clinical grade human embryonic stem cells in the Czech Republic

Popis výsledku v původním jazyce

Introduction: Human embryoblast can be adapted to in vitro culture, thus giving rise to selfrenewing population of pluripotent cells - human embryonic stem cells (hESC). Vast number of examples now document that hESC can be converted in vitro into cells with properly developed somatic phenotypes. Based on this intriguing property, innovative approaches are being designed that will enable exploitation of hESC and their differentiated derivatives in drug development, regenerative medicine, and in cell therapies in particular. Indeed, only clinical grade hESC, which fall within the definition of Advanced Therapy Medicinal Products (ATMP), can be therapeutically used. ATMP are required to be developed in adherence to the ethical standards and to be manufactured according to the current Good Manufacturing Practice and Good Tissue Practice, without a risk of contamination by adventitious agents. In the Czech Republic, clinically applicable lines of hESC have not yet been produced and/or manipulated that imposes a major barrier to any clinical development. Materials and Methods: Here we lay down the cornerstones to facilitate within-the-country R&amp;D towards clinical application of hESC by: (i) producing from ethically acceptable discarded human embryos a set of lines of hESC that will respect all the criteria applicable for ATMP; (ii) identifying and testing for their functionality all entry and ancillary materials, which will fulfil regulatory requirements; (iii) elaborating Standard Operating Procedures (SOP) for each individual step of manufacturing process; and (iv) establishing and embodying into SOP set of criteria to evaluate and demonstrate the quality and safety of the hESC. Results and Conclusions: We have established fully operative team covering the medical, technological, and instrumental aspects that are necessary for the proposed R&amp;D. These include: (i) involvement of Center of Assisted Reproduction providing expertise with manipulating human embryos and access to the potential donors (drs. Ventruba, Žáková, and Ješeta); (ii) proven expertise in deriving research grade lines of hESC (dr. Hampl); and (iii) direct access to cGMP facility with an adequate expertise in development of scenarios of medical application of ATMP (dr. Koutná).

Název v anglickém jazyce

The first ever effort to establish clinical grade human embryonic stem cells in the Czech Republic

Popis výsledku anglicky

Introduction: Human embryoblast can be adapted to in vitro culture, thus giving rise to selfrenewing population of pluripotent cells - human embryonic stem cells (hESC). Vast number of examples now document that hESC can be converted in vitro into cells with properly developed somatic phenotypes. Based on this intriguing property, innovative approaches are being designed that will enable exploitation of hESC and their differentiated derivatives in drug development, regenerative medicine, and in cell therapies in particular. Indeed, only clinical grade hESC, which fall within the definition of Advanced Therapy Medicinal Products (ATMP), can be therapeutically used. ATMP are required to be developed in adherence to the ethical standards and to be manufactured according to the current Good Manufacturing Practice and Good Tissue Practice, without a risk of contamination by adventitious agents. In the Czech Republic, clinically applicable lines of hESC have not yet been produced and/or manipulated that imposes a major barrier to any clinical development. Materials and Methods: Here we lay down the cornerstones to facilitate within-the-country R&amp;D towards clinical application of hESC by: (i) producing from ethically acceptable discarded human embryos a set of lines of hESC that will respect all the criteria applicable for ATMP; (ii) identifying and testing for their functionality all entry and ancillary materials, which will fulfil regulatory requirements; (iii) elaborating Standard Operating Procedures (SOP) for each individual step of manufacturing process; and (iv) establishing and embodying into SOP set of criteria to evaluate and demonstrate the quality and safety of the hESC. Results and Conclusions: We have established fully operative team covering the medical, technological, and instrumental aspects that are necessary for the proposed R&amp;D. These include: (i) involvement of Center of Assisted Reproduction providing expertise with manipulating human embryos and access to the potential donors (drs. Ventruba, Žáková, and Ješeta); (ii) proven expertise in deriving research grade lines of hESC (dr. Hampl); and (iii) direct access to cGMP facility with an adequate expertise in development of scenarios of medical application of ATMP (dr. Koutná).

Druh

O - Ostatní výsledky

CEP obor

—

OECD FORD obor

30214 - Obstetrics and gynaecology

Projekt

<a href="/cs/project/NV18-08-00412" target="_blank" >NV18-08-00412: Lidské embryonální kmenové buňky pro klinické aplikace: derivace a charakterizace</a><br>

Návaznosti

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

Rok uplatnění

2018

Kód důvěrnosti údajů

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