现有市场上干细胞治疗制品

botizhou

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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roczuu

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( d- a: w8 M! g2 T1 b俩印度、俩美国、三个韩国、一个英国，好像国外都是以药品的方式做，而国内基本是干细胞公司直接对接医院，没有中游环节，有两面监督难的问题，提倡国内的研发公司也用药品的方式推出自家的技术。

雁南飞

漏了一个重要的产品,  HEMACORD .( F# M0 @6 B% G! S5 _/ ~, y
实际上美国第一个干细胞产品，作为药品上市的，是FDA2011年11月批准的HEMOCORD，由NEWYORK BLOOD CENTRE申请，异体造血干细胞。FDA批准的自体干细胞他们自己都不算作药品的,这一点可以在FDA的生物制品网页上查到。

雁南飞

这是我以前搜索的美国批准的干细胞,可以补充上去:
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# p1 Q3 @' |* j6 I/ D产品名称        批准日期        成份        适应症        规格/剂量        厂家. h' S7 i# r, T7 g5 Q9 q
1  HEMACORD        2011-11-10        造血干        骨髓移植        2.5*E8/kg  NEWYORK BLOOD CENTRE INC.
- w* u, \0 C0 j2 b4 p2  CARTICEL        19970822        自体软骨        软骨缺陷        12*E6        Genzyme tissue repair
( q. c. b  r' G+ J- r3  LAVIV                自体成纤维细胞        面部除皱                Fibrocell Tech INc$ r( z7 w& y9 a$ \0 H& ~) c
4  Provenge        20100416        自体PBMC        前列腺癌                Denreon corporation7 ]2 R+ M3 l0 H) S
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蓝小鱼

2 CARTICEL        19970822        自体软骨        软骨缺陷        12*E6        Genzyme tissue repair
0 D! k1 ~7 l( a6 n) t4  Provenge        20100416        自体PBMC        前列腺癌                Denreon corporation* j3 z, r0 {4 m4 q
2，4都不算是干细胞治疗，2是自体软骨，4是免疫细胞。

雁南飞

是的，FDA认为自体的不是PRODUCT,所以HEMOCORD才是他们批的第一个细胞产品.

雁南飞

纠正楼主第6个
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Brand: Medipost
, o5 y. s3 u# L/ |; }* ^" MCountry: S. Korea' x' l$ q3 r0 G* y
& s1 K  F, P+ A( b7 P& m& f% B+ iRegulation: KFDA approved/ Q! w2 t: A: `) [: s' a5 C2 d6 c* b2 M
Condition: degenerative arthritis1 l! c5 T! m) q9 D7 d
, H4 J" t. ?: U% }+ j2 x7 NCell type: Umbilical cord MSC
9 w! {; p7 w" a0 {Donor type: allogeneic: y7 B, E! o#2 z) K7 }; g9 C! K, x  ]1 u
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这个细胞类型是脐带血间充质干细胞umbilical blood MSC，不是脐带间充质干细胞。