Informacja

Drogi użytkowniku, aplikacja do prawidłowego działania wymaga obsługi JavaScript. Proszę włącz obsługę JavaScript w Twojej przeglądarce.

Przeglądasz jako GOŚĆ
Zmień bibliotekę
Tytuł pozycji:

Adapting Preclinical Benchmarks for First-in-Human Trials of Human Embryonic Stem Cell-Based Therapies.

Tytuł :
Adapting Preclinical Benchmarks for First-in-Human Trials of Human Embryonic Stem Cell-Based Therapies.
Autorzy :
Barazzetti, G.
Hurst, S.A.
Mauron, A.
Stem cells translational medicine
Pokaż więcej
Temat :
Benchmarking/ethics
Benchmarking/legislation & jurisprudence
Cell Differentiation
Cell Lineage
Cell Survival
Clinical Trials as Topic/ethics
Clinical Trials as Topic/legislation & jurisprudence
Embryonic Stem Cells/transplantation
Humans
Models
Animal
Parkinson Disease/diagnosis
Parkinson Disease/surgery
Patient Safety
Phenotype
Policy Making
Research Design/legislation & jurisprudence
Risk Assessment
Stem Cell Transplantation/adverse effects
Stem Cell Transplantation/ethics
Stem Cell Transplantation/legislation & jurisprudence
Stem Cell Transplantation/methods
Translational Medical Research/ethics
Translational Medical Research/legislation & jurisprudence
Źródło :
Stem cells translational medicine, vol. 5, no. 8, pp. 1058-1066
Rok publikacji :
2016
Kolekcja :
Université de Lausanne (UNIL): Serval - Serveur académique lausannois
Typ dokumentu :
article in journal/newspaper
review
Język :
English
ISSN :
2157-6564
Relacje :
info:eu-repo/semantics/altIdentifier/pmid/27334488; info:eu-repo/semantics/altIdentifier/pissn/2157-6564; https://serval.unil.ch/notice/serval:BIB_4DACD45A53CA; urn:issn:2157-6564
DOI :
10.5966/sctm.2015-0222
Dostępność :
https://doi.org/10.5966/sctm.2015-0222
https://serval.unil.ch/notice/serval:BIB_4DACD45A53CA
Numer akcesji :
edsbas.9DD07053
Czasopismo naukowe
As research on human embryonic stem cell (hESC)-based therapies is moving from the laboratory to the clinic, there is an urgent need to assess when it can be ethically justified to make the step from preclinical studies to the first protocols involving human subjects. We examined existing regulatory frameworks stating preclinical requirements relevant to the move to first-in-human (FIH) trials and assessed how they may be applied in the context of hESC-based interventions to best protect research participants. Our findings show that some preclinical benchmarks require rethinking (i.e., identity, purity), while others need to be specified (i.e., potency, viability), owing to the distinctive dynamic heterogeneity of hESC-based products, which increases uncertainty and persistence of safety risks and allows for limited predictions of effects in vivo. Rethinking or adaptation of how to apply preclinical benchmarks in specific cases will be required repeatedly for different hESC-based products. This process would benefit from mutual learning if researchers included these components in the description of their methods in publications. To design translational research with an eye to protecting human participants in early trials, researchers and regulators need to start their efforts at the preclinical stage. Existing regulatory frameworks for preclinical research, however, are not really adapted to this in the case of stem cell translational medicine. This article reviews existing regulatory frameworks for preclinical requirements and assesses how their underlying principles may best be applied in the context of human embryonic stem cell-based interventions for the therapy of Parkinson's disease. This research will help to address the question of when it is ethically justified to start first-in-human trials in stem cell translational medicine.

Ta witryna wykorzystuje pliki cookies do przechowywania informacji na Twoim komputerze. Pliki cookies stosujemy w celu świadczenia usług na najwyższym poziomie, w tym w sposób dostosowany do indywidualnych potrzeb. Korzystanie z witryny bez zmiany ustawień dotyczących cookies oznacza, że będą one zamieszczane w Twoim komputerze. W każdym momencie możesz dokonać zmiany ustawień dotyczących cookies