韩政府首次批准胚胎干细胞开展临床试验

sunsong7

- C1 l& i+ b6 E4 I) e* g" S% M5 L! ~9 I/ y# u1 j! m
Bioethics body approves first embryonic stem cell test, w* r; i* I1 F  i- s5 k( j2 A) {
2011-04-27  http://www.koreaherald.com/natio ... MLId=20110427001054
7 [8 I! C: P& I
. M& B( }- U- I6 V% J% ~/ X( @韩国伦理委员会批准胚胎干细胞开展临床试验用于治疗黄斑变性导致视力下降# \- p+ K: i# N1 ^
9 X2 n) A7 A3 _4 }6 q" G8 Z" s& x
国家生命伦理审议委员会（以下简称“国生委”）27日批准了针对 “斯特格黄斑变性病”(Stargardt’s Macular Dystrophy)的胚胎干细胞临床试验。这是韩国政府批准的首个胚胎干细胞临试验，因此备受瞩目。 “斯特格黄斑变性病”又叫做眼底核黄素斑点，是遗传性疾病。典型的斯特格黄斑变性病变开始于青少年期，患者首先含糊地抱怨视力似乎有些减退。但国生委禁止利用通过单细胞(处于四细胞阶段的胚叶细胞)培育出的人类胚胎干细胞进行临床试验。国生委表示，只有胚胎干细胞在体外分化成为特定的组织干细胞或者成熟细胞后，才可用于临床治疗。这样才能符合生命伦理规范。
# v! g9 O8 ]" i$ e0 z; N' Q) Q6 D- {# w' i
1 R7 k7 o# h1 N' |3 m3 _0 g9 {
A clinical test using embryonic stem cells was approved for the first time in Korea on Wednesday. " _$ G; s1 h& b& O" [9 \

9 D5 H& x8 D8 y1 `* p# Q, `　The National Bioethics Committee said it had approved CHA Bio & Diostech’s request to conduct a clinical test using embryonic stem cell in treating macular degeneration which can lead to sight loss.
- z: [* b7 E/ s% H& w
2 {9 t5 M6 L% h% i1 k8 k　The test in particular will be conducted to prove the stem cells’ effect on Stargardt’s Macular Dystrophy, which is known to be caused by “faulty” versions of genes. The disease affects teenagers most, and 50 percent of those afflicted lose their sight before turning 50.
1 }5 {, T# X/ B% z. C( ?" g8 E: a3 n
　If the test succeeds, 30,000 to 50,000 SMD patients worldwide and more than 100 million people suffering from macular degeneration could benefit from the treatment, Professor Chung Hyung-min of CHA Bio & Diostech said.# ]4 w! ?' [+ ]) R
3 Z! T2 H) i: V& k: t" }
　The test will be taken on three patients over the next 18 months and observation will be mainly focused on whether embryonic stem cells could prevent blindness.
; G/ y5 k& Y, H3 h3 U
3 k( I& ~. K& F- w3 T　CHA and its partner ACT, an American firm which has already gained approval for the study by the U.S. Food and Drug Administration, have confirmed their effectiveness on laboratory mice.
2 S4 z4 I8 F" @/ j/ `6 d' G
$ b+ G7 w/ u+ s0 a' B3 i　The approval is the second of its kind in the world following the U.S.’s decision to allow tests to treat spinal cord injury in 2009.
9 p+ l; d# ?4 f, v. {% l3 o
( P) \9 T' a" b4 `, ~　“Patients will be injected with retinal cells developed from embryonic stem cells extracted from fertilized eggs. We hope the damaged retina will be recovered,” he said. Chung said the examination process is much simpler than that of a spinal test.- Q* h+ m* _1 I  u# A5 E& M7 p

0 F  a7 h# w4 p" a, s" R1 \　“If lucky, we might produce the actual treatment earlier than the U.S.,” he said.   * W" ~5 ]8 \2 D" J* }2 j: R/ u% `7 ], u
　Stem cell treatments are opposed by some who say using fertilized eggs for therapies degrades human life. The possibility of stem cells causing side effects such as possible tumors is also a worry. $ ]- _- v! z1 w# l
% {+ g: O# M. l( J6 H
　“But the test will pave the way to treatment of intractable diseases. We have the technology to prevent side effects. You will not need to worry too much about it,” Chung said.
% a" w5 p/ f' D, U4 [  @
, j2 S* G" Y' |& [+ }8 n" [　Meanwhile, the council, which consists of seven scientists, seven non-scientists and six high-ranking government officials, rejected CHA’s bid to establish stem cell lines using “fresh” embryos. The eggs used for the SMD test will be those that are fertilized, extracted and frozen for pregnancy but that have been kept frozen for more than five years, meaning they are difficult to use for their original purpose.% |4 U! N1 B* o1 j8 v

" }. H& E: ]& c( V/ n8 U# a/ F　By Bae Ji-sook