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Stem cell therapeutic products on the market
. @5 ?) d$ h1 sUpdated on Mar. 6, 2012
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Inclusion criteria:0 X- r9 _3 N1 _' h. L6 i* D4 ]
• Stem cell therapeutic product (drug) was defined as it claimed by a company or regulatory agency. 4 j" H8 F- Z/ I$ _& ]5 w
• The product is authorized for sales and available on the market. 8 H$ e* `6 ^* t+ Y" t, C7 n
• The product is approved and/or regulated by federal agency. 0 Q8 u- D0 W$ ]- U0 p
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The list:, N: C) J) z5 u9 P7 g: [
1. ReliNethra$ w* q, t2 _+ }, O3 O
Brand: Reliance Life Science3 i8 e8 X O K D2 @& E. k
Country: India1 e p( a) r9 V$ E
Year or release: 2008
" @4 D- A+ O) V1 ]) L" ] @9 @Regulation: unknown8 X) _/ p1 x. X
Condition: eye diseases
, a1 w3 @3 S0 \2 M% O5 YCell type: limbal stem cells
8 m& Y, q: ^" t# L4 c* pDonor type: autologous+ b; T( |) _5 a6 S9 i" K7 U; ^: j
2. CardioRel
0 F s. s- H4 U8 H$ z& n' n" JBrand: Reliance Life Science
$ O0 X7 b) y# s* D/ Z0 uCountry: India
0 f1 S/ ]& k cYear or release: 20104 J% j; A& O* u% ] r4 ^
Regulation: unknown
8 r5 n9 @5 y( Y; D* ] YCondition: post acute myocardial infarction
! m7 J0 i" R9 E9 A! a/ M& ACell type: BM MNC/ MSC5 G" T$ j6 w# T( _
Donor type: autologous! J# k& P# J2 @ F
3. Trinity Evolution
% O% a4 Q9 K& C# z3 ^4 G ~Brand: Orthofix
: R! E& g p9 ~6 q( p, kCountry: USA' g6 O1 w. J2 U3 |6 t. H( [8 g
Regulation: FDA (HTC/P, 21 CFR, part 1271)2 r8 y+ @6 w. o( k; M
Condition: orthopedics# Z& W6 g" r; q$ |
Cell type: bone matrix with MSC m( o# P! z W$ I
Donor type: allogeneic5 u2 a: z5 F/ a& a1 P0 v: [
4. Osteocel Plus
8 D/ { z" F0 [Brand: NuVasive- d9 x1 P5 v5 f: D' s( N4 {
Country: USA0 U" z& Y* A- D9 l9 Q: g) k
Regulation: FDA (HTC/P, 21 CFR, part 1271)6 f* l* R- p& I0 f7 K, q% ?
Condition: orthopedics* ]: _7 Q$ Q. J5 Q* ?1 F0 \, E
Cell type: BM MSC s9 J6 G: Y" W9 i" s. r. w
Donor type: allogeneic
9 [% K; i+ F/ {6 E0 @8 P3 ?5. HeartiCellGram-AMI& O4 A0 K7 W. K9 ~& \& y: ]0 ~
Brand: FCB PharmiCell
1 h* v/ C4 L% L( O. ~Country: S. Korea
2 t& l" ^7 s9 J% j0 ]Regulation: KFDA approved
5 H- B9 f9 y- e9 WCondition: post acute myocardial infarction
, M* y, W {. ]Cell type: BM MSC/ w! I- U; a# t0 C$ x
Donor type: autologous3 n" d# S& H2 g4 C
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! C/ ]& c b" e7 l8 M4 l6. Cartistem- y2 O- N5 T3 `; }- E* I% v
Brand: Medipost' Q2 s0 k) o$ @$ L( c9 v, A( W
Country: S. Korea# U Q9 ^! ?$ }( N7 j
Regulation: KFDA approved
/ F' k2 n3 L5 X/ WCondition: degenerative arthritis
! N5 V* ^; N, w$ Y: sCell type: Umbilical cord MSC$ U! q! A8 h) ]7 Z0 N
Donor type: allogeneic
: g G. g7 \" l" M$ e5 [' C7. Cupistem. ^4 u% }0 b* k4 \+ G$ I
Brand: Anterogen1 k- r1 G, t6 d8 |( d
Country: S. Korea
+ R" p! ?! m2 o5 X4 mRegulation: KFDA approved
) }$ S* O' @/ f6 K& U# gCondition: anal fistula (Chron’s disease)
( |. D+ G; [7 P2 d# ?$ vCell type: Adipose MSC
7 {6 e% Q( M- f6 a m1 O( ODonor type: autologous: @- b+ H1 G' A
8. AlloStem
, {+ k1 Y, K: V' s8 J+ \5 {Brand: AlloSource
+ t$ x# e" q/ g( W: U7 N. hCountry: US M) F3 b* a! x* ]4 c" A
Regulation: FDA (HTC/P, 21 CFR, part 1271)
! ~4 y- F Y2 E% q& D: uCondition: orthopedics
3 I) Z- [( [0 A) [5 uCell type: Bone matrix + BM MSC
9 @& F ?: t6 g @' P8 wDonor type: allogeneic
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n# `$ y! F/ _5 I: ^, z4 KAbbreviations: FDA – Food and Drug Administration, KFDA – Korean FDA, MSC – mesenchymal stromal cells, BM – bone marrow, MNC – mononuclear cells.
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