Regulatory considerations for the development of autologous induced pluripotent stem cell therapies.

Abstract:

:Induced pluripotent stem (iPS) cells offer tremendous opportunity for the creation of autologous cellular therapies, in which gene correction or the avoidance of immune response issues are desirable. In addition, iPS cells avoid the ethical concerns raised by the sourcing of human embryonic stem cells (hESCs) from embryos. iPS cells share many characteristics with hESCs and it is anticipated that existing experience with hESCs will translate to rapid progress in moving iPS cell-derived products toward clinical trials. While the potential clinical value for these products is considerable, the nature of current manufacturing paradigms for autologous iPS cell products raises considerable regulatory concerns. Here, the regulatory challenges posed by autologous iPS cell-derived products are examined. We conclude that there will be considerable regulatory concerns primarily relating to reproducibility of the manufacturing process and safety testing within clinically limited time constraints. Demonstrating safety of the final cell product in an autologous setting will be the single greatest obstacle to progressing autologous iPS cell-based therapies into the clinic.

journal_name

Regen Med

journal_title

Regenerative medicine

authors

Carpenter MK,Couture LA

doi

10.2217/rme.10.55

subject

Has Abstract

pub_date

2010-07-01 00:00:00

pages

569-79

issue

4

eissn

1746-0751

issn

1746-076X

journal_volume

5

pub_type

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