Team applies for first stem cell trialAn application to conduct the nation’s first-ever clinical trial of human embryonic stem cell-based therapy on a human patient is being reviewed by health authorities, the JoongAng Ilbo confirmed yesterday.
If permission is granted, Korea will become the second country after the United States to start clinical tests of the controversial therapy.
The Korea Food and Drug Administration said yesterday that a team led by Professor Chung Hyung-min of the Stem Cell Institute of CHA University’s College of Medicine and the U.S. biotech company Advanced Cell Technology Inc. have jointly applied for permission to conduct clinical trials. The test is intended to regenerate damaged cells of a blind patient by injecting retinal pigment epithelial (RPE) cells from embryonic stem cells.
Chung, 46, is a pioneer in stem cell therapy in Korea. In May 2009, his research project to clone embryonic stem cells from somatic cells was approved by the National Committee on Bioethics for the first time since the 2005 scandal over Hwang Woo-suk’s fraudulent stem cell research.
Chung’s team first submitted its application to conduct a clinical trial involving 12 patients in April, and more documentation was submitted later, the KFDA said.
In November 2009, Chung also filed an application to the U.S. Food and Drug Administration to run a clinical trial for the same treatment.
Embryonic stem cells are derived from pre-implantation-stage embryos. Chung’s team used frozen embryos left over from fertility treatments to obtain the RPE cells for the trial.
The procedure is similar to the world’s first clinical trial of human embryonic stem cell-based therapy that began Monday by the California-based Geron Corporation, except that test was intended to treat patients with spinal-cord injuries.
There are 16 clinical tests for stem cell treatments proceeding in Korea, but they use stem cells from adults while Chung’s team will use cells from embryos.
Embryonic and adult stem cells have different advantages and disadvantages because of their differing abilities to regenerate. Adult stem cells can only grow into the same kind of tissue that they came from, and isolating them from adult tissue is relatively challenging.
Embryonic stem cells, in contrast, are relatively easy to culture, have a strong ability to regenerate and can grow into any tissue type. In Chung’s trial, for example, one risk is that the embryonic stem cells could regenerate into cells other than RPE cells.
“Because embryonic stem cells have potentials to differentiate into various cells, we are reviewing comprehensive risks,” said Park Yun-ju, head of the KFDA’s Advanced Therapy Products Division. “We will grant permission for the clinical trial as long as Chung’s treatment is safe and effective.”
Chung said he developed the technology in 2006 and conducted animal tests for years to improve its safety and effectiveness.
The trial, if granted, is likely to create an ethical controversy in Korea because it uses human embryos.
“Extracting embryonic stem cells is a destruction of life,” said Father Remigio Lee Dong-ik, head of the Catholic Medical Center. “A clinical trial must never be granted when the safety is not guaranteed.”
He also said there are more ethical ways, including adult stem cell therapy, to treat what are considered incurable conditions.
Chung said he was aware of the opposition, but he saw no ethical problem with his research.
“We will use fertilized eggs that were otherwise slated to be destroyed, and we obtain them through donations,” he said. “The people who oppose the research oppose the use of embryos for all purposes. They even disagree with in vitro fertilization, but the pioneer of that technique won the Nobel Prize this year.”
By Shin Sung-sik, Park Tae-kyun [firstname.lastname@example.org]