The government of South Korea has just presented a boon for the biotech industry by easing regulations considerably for gene therapy and embryonic stem cell research.It allows for gene therapy product development that the industry has wanted for a long time.Prime Minister Lee Nak-yon of the Advanced Institute of Convergence Technology in Gyeonggi, chaired a meeting on Nov. 30 about how to reduce and consolidate restrictions.The Ministry of Health and Welfare announced, "We will expand the allowable range of embryonic stem cell and genetic scissors research to the same level as advanced countries."
This comes less than a month after the recloning of Snuppy, the first dog in the world to be cloned.The real Snuppy passed away in April 2015, but South Korean researchers in the U.S.announced on November 2017 the birth of three new clones of the Afghan dog.This, of course, represents a major breakthrough in stem cell research as they've effectually immortalized Snuppy via stem cells extracted from the dog's fat when the original Snuppy was only five years old.
The new study was published in Scientific Reports, and it reads: "Three healthy reclones of Snuppy are alive, and as with Snuppy we do not anticipate that the reclones will go through an accelerated rate of aging or will be more prone to develop diseases than naturally bred animals," which is an optimistic prognosis.Clones are, at present, expected by the scientific community to experience accelerated aging, and they're certainly supposed to be more sickly than average people.These new clones reportedly are not prone to disease or accelerated aging.
This is one area of legislation where South Korea had begun to fall behind some of the other most technologically advanced countries in the world like Israel or the UK Current laws make bioethical restrictions against research and development related to stem cells at all, which certainly includes human embryos.They also include strict regulations against any such study or development of somatic cell-based gene therapies.As such, embryonic stem cell research in South Korea has, heretofore, has only been permissible for 20 specific diseases, all either rare, incurable or both.
Similarly, research for gene therapies is only permissible for the deadliest diseases, most of which are genetic disorders like AIDS and cancer.The proposed new system has yet to be implemented and will be formally introduced as a bill sponsored by the Private-Public Bioethics Consultative Body.The committee was founded this year for the purpose of enhancing regulatory systems and updating ethics in light of new life science technologies today and new information that has come to light since the original regulations were imposed.
The research team Stateside reports that both Snuppy and her cell donor, Tai, were healthy overall until developing cancer.Both died from the cancer at the ages of 10 and 12 respectively, which is actually about the average lifespan for their species.They anticipate that this new generation of clones will serve as a flagship study for the global scientific community regarding the health and life expectancy of cloned animals.The paper does not, however, talk about the prospect of human cloning, which is still illegal in the U.S.
Study co-author CheMyong Jay Ko at the University of Illinois says, "We do not imagine using these technologies for cloning humans." Known bioethicist Arthur Caplan contends that what he calls the "battle over humans" will come down to genetic engineering. "What we'll see is more attempts to engineer humans," he claims, and he adds that CRISPR and future gene-editing techniques are likely to be the primary vehicle for that trend. "There may be an occasional single oddball that wants to clone themselves to reproduce, but it's going to be on the margins." They don't see this breakthrough as opening the floodgates to a lot of human cloning.
The new regulation system in South Korea is being referred to as a "negative regulation" system, and it allows research for treatment first before determining what regulations may or may not be applied.Technologies and techniques like xeno-transplantation and gene editing are the collective reason why this legislative change is happening, which gives the biotech industry positive ideas about how the new system will be applied.The only caveat thus far is that the committee involves experts on religion, law, and ethics, and many of them are opposed to this change.
On Thursday, Kang Stem Biotech announced that the R.O.K.Ministry of Food and Drug Safety approved the start of phase III for the Furestem-AD clinical trial.Furestem-AD is the world's first atopic dermatitis medication based on stem cell development, and it's considered one of the most innovative things being developed in the global pharmaceutical space.According to the Korea Biotechnology Industry Organization, "Existing atopic dermatitis drugs are not free from side effects and their efficacy has been limited to symptom alleviation; however, stem cell-based products are expected to remove the fundamental cause of the disease once put to commercial use."