Stem Cell Processing (Stem Cells in Clinical Applications)

224

Mesenchymal stem cells (MSCs) ( cont. )
ex vivo-expansion
harvesting adherent cells , 122
media , 117–120
monolayer culture , 120–121
suspension culture , 120–121
GMP (see Good manufacturing practice
(GMP) )
Hearticellgram ® , 44
immune modulation , 38 , 41–44
indications , 3
International Society of Cellular Therapy , 37
liver, lung, and kidney diseases , 52 , 53
non-expanded , 115 , 116
osteoarthritis , 46 , 48–50
Osteocel ® Plus , 44
principles , 2
prochymal , 46
safety of , 54–57
sources , 38–40
stroke , 54
tissue regeneration , 41 , 42
tissue repair , 38
Trinity ® Evolution™ , 44
Myogenesis , 141 , 148

N
National Bioethics Advisory Commission’s
(NBAC) report , 10
Neural stem cells (NSCs) , 2

O
Osteoarthritis , 46 , 48–50 , 101
Osteogenesis , 145 , 147 , 154

P
piggyBac vector , 80
Polyhormonal (PH) cells , 90

R
Regenerative medicine
cardiac differentiation , 89 , 90
diabetic mellitus , 90 , 91
EB formation , 88
generation protocols , 87
liver disease , 90 , 91
neural differentiation , 88
SMAD signaling pathway , 88
somatic cells, reprogramming , 87
TGF-β receptors , 88
UCB , 173 , 174 , 176 , 177

Regulators Forum Cell Therapy Group

(RFCTG) , 22–23

Regulators Forum Gene Therapy Group

(RFGTG) , 22–23

S

Sendai virus , 81

Senescence , 73

Sepax ® system , 137

Serum-free medium , 136

Somatic cell nuclear transfer (SCNT) , 10 ,

191–192

Stem cell banks (SCBs) , 166 , 168–171

Stem cell therapy

biological medicine , 12–13

clinical applications , 2–3

EMA and FDA

AHCTA , 24

APEC/LSIF , 23

FACT , 24

FDA-EMA-Health Canada ATMP

Cluster , 22

future global regulation , 24

IMDRF , 23

RFCTG and RFGTG , 22–23

ethical and legal concerns

cadaveric fetal tissue , 9–10

clinical use , 12

embryo , 6–7

infertility treatment , 8

informed consent , 11

oocytes , 8–9

research purposes , 8

SCNT , 10

global legal positions

consensus principles , 20–21

harmonization , 19–20

issues of difference , 21

regulatory approaches , 14–19

global regulatory framework , 1

guidelines and legislation , 1

pertinent issues and controversial

reports

circumvention tourism , 5

clinics offering , 3

complications , 4

scienceploitation , 4

stem cell tourism , 4

travel , 5

USA and Australia pay , 5

vs. reproductive cloning , 10–11

societal perceptions , 12

stem cell biology , 2

Stroke management , 54

Index