Legal and Policy Frameworks for Clinical-Grade Stem Cell Banking
Notice bibliographique
Résumé
Introduction The potential applications of cell therapy and regenerative medicine make this area of research a dynamic, fast evolving field. To accommodate the considerable growth of cell research, banks have been created to provide researchers with access to current, high quality cell lines.' Banks accept and distribute cell lines to and from researchers, providing documentation on their use and provenance. Banks fulfill important functions to ensure the cell lines are ethically sourced and the quality of cell lines is reliable,2 helping to realize the full potential of cells. While many clinical applications of cell research remain distant possibilities, some novel cell-based therapies are beginning to be developed and tested. As these efforts continue, cell banks will increasingly take on an important role in the distribution of clinical-grade cell lines that can be used to develop therapies administered to humans. In December 2011, the first clinical-grade cells were deposited with the United Kingdom Stem Cell Bank (UKSCB),3 marking a shift to a new era in cell banking. More recently, plans were announced to establish a of clinical-grade induced pluripotent cells (iPSCs) in Japan.4 As the banking of clinical-grade cells gains momentum, this will bring new regulatory and policy issues into play. The aim of this article is to describe the legal and policy framework relevant to cell banking, with a focus on clinical-grade cell lines, and to identify some of the issues and challenges that arise in the context of clinical-grade cell banking. Stem Cell Banks The phrase stem cell bank is sometimes used to refer to both cell registries and repositories. Registries are databases that collect and provide information on derived cell lines. The European Human Embryonic Stem Cell Registry and the UMass International Stem Cell Registry are examples of cell registries.' Repositories are facilities that process, store, and maintain the actual cell lines such as the UK Stem Cell Bank (UKSCB), the Spanish National Cell Bank, and the US Wisconsin International Stem Cell Bank (WISC).Registries and repositories are not mutually exclusive and have complementary functions.' They provide researchers with information about matters such as cell provenance and culture methods, enabling more accurate and reliable research. Coordination among these functions is critical for the advancement of cell research, providing researchers with the materials and information to produce the highest quality work. This article is primarily concerned with repositories and unless otherwise indicated, the term stem cell bank in this article refers to banks that are acting as repositories and are actually handling human cells. Stem cell banks play a significant role in the advancement of cell research. Given the rapid expansion of the science, centralized cell banks are needed to provide researchers with access to cell lines!' By providing access to existing lines, banking reduces the need for derivation of new cell lines; in the case of human embryonic cells, in particular, this has ethical value because it reduces the number of human embryos that must be destroyed.' Banks also reduce unnecessary duplication in research by screening applications for use of cell lines,' and minimize waste and errors by promoting standardization.By ensuring the maintenance of only ethically sourced cells using accepted quality conditions, cell banks promote consistency, safety, and ethical conduct in cell line derivation and subsequent use in research. The benefits of using cell banks will also extend to clinical applications. There is general agreement that the use of centralized banks will serve the development of cell research, especially as it moves into clinical translation. …
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,001 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,001 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découleClassification
machine, non validéePrédiction automatique; un appel candidat d’une seule tête enseignante, pas un consensus.
Le détail, modèle par modèle et score par score, se trouve en fin de page sous « Comment cette classification a été obtenue ».