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2015 ; 4
(4
): 389-400
Nephropedia Template TP
gab.com Text
Twit Text FOAVip
Twit Text #
English Wikipedia
Concise review: workshop review: understanding and assessing the risks of stem
cell-based therapies
#MMPMID25722427
Heslop JA
; Hammond TG
; Santeramo I
; Tort Piella A
; Hopp I
; Zhou J
; Baty R
; Graziano EI
; Proto Marco B
; Caron A
; Sköld P
; Andrews PW
; Baxter MA
; Hay DC
; Hamdam J
; Sharpe ME
; Patel S
; Jones DR
; Reinhardt J
; Danen EH
; Ben-David U
; Stacey G
; Björquist P
; Piner J
; Mills J
; Rowe C
; Pellegrini G
; Sethu S
; Antoine DJ
; Cross MJ
; Murray P
; Williams DP
; Kitteringham NR
; Goldring CE
; Park BK
Stem Cells Transl Med
2015[Apr]; 4
(4
): 389-400
PMID25722427
show ga
The field of stem cell therapeutics is moving ever closer to widespread
application in the clinic. However, despite the undoubted potential held by these
therapies, the balance between risk and benefit remains difficult to predict. As
in any new field, a lack of previous application in man and gaps in the
underlying science mean that regulators and investigators continue to look for a
balance between minimizing potential risk and ensuring therapies are not
needlessly kept from patients. Here, we attempt to identify the important safety
issues, assessing the current advances in scientific knowledge and how they may
translate to clinical therapeutic strategies in the identification and management
of these risks. We also investigate the tools and techniques currently available
to researchers during preclinical and clinical development of stem cell products,
their utility and limitations, and how these tools may be strategically used in
the development of these therapies. We conclude that ensuring safety through
cutting-edge science and robust assays, coupled with regular and open discussions
between regulators and academic/industrial investigators, is likely to prove the
most fruitful route to ensuring the safest possible development of new products.
|*Stem Cell Transplantation
[MESH]
|Cell- and Tissue-Based Therapy/adverse effects/*methods
[MESH]
free
free
free
