Evaluation of Stem Cell-Derived Cellular Therapy Products.
Toxicol Pathol
; 49(7): 1288-1293, 2021 10.
Article
em En
| MEDLINE
| ID: mdl-31918631
ABSTRACT
Although there is an increase in the development of new cellular therapies, few guidelines have been published to assist in the design of preclinical studies. As no product and therapeutic intention is entirely alike regulators and Contract Research Organizations need to treat each project on a case-by-case basis. One of the most important considerations in study design is to retain all tissues from the study, thereby allowing for further analysis of tissues should unexpected effects be seen in clinical studies. Input from the pathologist at the earliest stages of study design regarding animal selection, cell markers, and phased tissue examination improves the scientific integrity of the study.
Palavras-chave
Texto completo:
1
Base de dados:
MEDLINE
Assunto principal:
Projetos de Pesquisa
/
Células-Tronco
Tipo de estudo:
Guideline
Limite:
Animals
Idioma:
En
Ano de publicação:
2021
Tipo de documento:
Article