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Stem cell therapeutic products on the market
. z! R8 L- \9 B: ]8 tUpdated on Mar. 6, 20126 y* E `$ z4 a! A* r( O
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Inclusion criteria:& _( e, Y- ]3 b' a/ F$ [- R2 m: P$ X
• Stem cell therapeutic product (drug) was defined as it claimed by a company or regulatory agency. ; t2 ?* ]5 f3 {" B! ?
• The product is authorized for sales and available on the market. 8 k. \; E( U P) n% s9 F
• The product is approved and/or regulated by federal agency. ' f$ S0 G% c+ c; k4 L
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The list:
, ~0 x7 J+ y1 F# r1. ReliNethra+ X5 a, C8 L/ F* M' `
Brand: Reliance Life Science X* ]; k6 _2 ~1 T1 k- L9 m
Country: India
' o. |( }( d: F/ }5 N# q. HYear or release: 2008
" x" f: j) f' O+ W, Z, _Regulation: unknown& g/ V/ V. Q0 y# n
Condition: eye diseases& `) c8 C6 }. g
Cell type: limbal stem cells/ Q% g4 J4 a n
Donor type: autologous
5 t7 H' ]. M3 D7 N8 Z) U2. CardioRel! P3 I/ |0 J5 n2 p* r! u$ e
Brand: Reliance Life Science
$ x, s2 N9 Z) a" x& {; ?6 n1 `) fCountry: India
6 c; W, ]1 X* i" aYear or release: 2010
7 W3 A- s3 C4 s; }3 V: W; g, LRegulation: unknown6 ^/ w# Q: H/ y) d, c" L; r
Condition: post acute myocardial infarction+ X, l* T) k( i0 Q9 s
Cell type: BM MNC/ MSC. L% O; I- Y! C! p% T3 F E H
Donor type: autologous
2 P6 e3 V7 h1 I, }1 C* e3. Trinity Evolution
% u _% X; r- gBrand: Orthofix
+ I/ A* q7 e1 e& LCountry: USA
% F, A" ?/ p* N# IRegulation: FDA (HTC/P, 21 CFR, part 1271)5 M L9 K* h6 G) S
Condition: orthopedics7 o+ x8 z/ T1 `& i# M+ N9 F+ n
Cell type: bone matrix with MSC
9 P8 M r6 N" H7 b- o& DDonor type: allogeneic% S% s6 |( e# ?) ^+ M/ u
4. Osteocel Plus) c# ]* Y# @' I
Brand: NuVasive
( t3 \' w& z) i% NCountry: USA
# b$ y, j. ^; P& w$ \+ I5 lRegulation: FDA (HTC/P, 21 CFR, part 1271)7 D& a4 ]- U4 x
Condition: orthopedics
& B2 ~% j" D& T7 _% S& ~ K6 b1 GCell type: BM MSC7 R7 ~2 i4 V/ t* T
Donor type: allogeneic
! T& w. K" C! Y8 p2 v5. HeartiCellGram-AMI
' G2 I! e# o5 v% ]' z0 OBrand: FCB PharmiCell9 S3 P2 ]1 c0 E! R
Country: S. Korea
l$ Z2 p9 N/ ]% T9 hRegulation: KFDA approved
9 }( @ q5 W2 t H. w0 ECondition: post acute myocardial infarction
% L0 I* P* X2 z& _8 ~0 h$ _% l% uCell type: BM MSC6 j" b$ o! v+ f( K1 C
Donor type: autologous' d" `9 Z; Q' Y4 ~# Y3 f
9 g2 r4 q F Q3 ?
( _( ~* ^8 G8 b! t3 x% f6. Cartistem
% p# O" s$ z' m! u# L- h' b* EBrand: Medipost
; q n6 i: }1 B: C: F b# ZCountry: S. Korea1 H- ^+ K$ z/ n9 J6 B, Y7 v
Regulation: KFDA approved
% s6 w! E8 @; y( a3 DCondition: degenerative arthritis
s: w" k! ^5 e8 `9 D1 S3 TCell type: Umbilical cord MSC4 |8 x8 ]% h$ t+ W
Donor type: allogeneic
u5 i- N) l3 g* e. \2 O7. Cupistem2 u2 _, p$ X: }
Brand: Anterogen5 I( W# Z1 N4 A
Country: S. Korea
6 x$ J% [9 E0 g! o. _# R3 cRegulation: KFDA approved
% j! ~. x' U8 v+ [5 ^Condition: anal fistula (Chron’s disease)' \( J9 f0 ^1 H
Cell type: Adipose MSC+ E- ]/ j' R" e# M( L* P# K* W4 v) _- l4 P
Donor type: autologous
g c0 n" B# r4 B3 |/ x% _8. AlloStem
- j. S, L H4 l; EBrand: AlloSource
* N4 ?! T+ g" Y$ D. ^+ g4 @Country: US
& [' ^3 S8 E, n: X" J3 ?5 ZRegulation: FDA (HTC/P, 21 CFR, part 1271)2 ~! u! p. n9 |: _, j6 w5 }
Condition: orthopedics+ j1 G; y; ~( H8 ?7 H' n
Cell type: Bone matrix + BM MSC
2 L$ Q }2 l# [! {' X9 gDonor type: allogeneic
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( |0 N; g, ~. a# zAbbreviations: FDA – Food and Drug Administration, KFDA – Korean FDA, MSC – mesenchymal stromal cells, BM – bone marrow, MNC – mononuclear cells.
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发表于 2012-3-9 15:44
