Regulatory considerations for pluripotent stem cell therapies.
Prog Brain Res
; 230: 151-163, 2017.
Article
en En
| MEDLINE
| ID: mdl-28552227
ABSTRACT
The development of pluripotent stem cell (PSC) therapies is rapidly advancing, and a number of PSC-derived cell products are currently being tested in clinical trials. The biological complexity of these therapies results in specific challenges in complying with regulatory guidelines. This includes the choice of starting material, reproducible and consistent manufacturing, and preclinical safety and efficacy assessment of the PSC-derived product. This review discusses current US cell therapy regulations and strategies for compliance with these regulations when developing PSC-derived products.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Banco de datos:
MEDLINE
Asunto principal:
United States Food and Drug Administration
/
Células Madre Pluripotentes
/
Regulación Gubernamental
/
Industria Farmacéutica
/
Tratamiento Basado en Trasplante de Células y Tejidos
Tipo de estudio:
Guideline
/
Prognostic_studies
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Prog Brain Res
Año:
2017
Tipo del documento:
Article