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UK approves mitochondrial donation babies
Progress Educational Trust
01 January 2017
The UK has become the first country in the world to formally approve the creation of IVF embryos through mitochondrial donation.
On 15 December 2016, following a scientific report into the efficacy and safety of the procedure, the Human Fertilisation and Embryology Authority (HFEA) ruled that the therapy should be approved for 'cautious clinical use'. The UK government legalised mitochondrial replacement therapy (MRT) in 2015.
Fertility clinics can now apply for a licence to carry out MRT to prevent mitochondrial disease, meaning that the first babies could potentially be born around this time next year.
'Today's historic decision means that parents at very high risk of having a child with a life-threatening mitochondrial disease may soon have the chance of a healthy, genetically related child. This is life-changing for those families,' said Sally Cheshire, chair of the HFEA. 'We feel now is the right time to carefully introduce this new treatment in the limited circumstances recommended by the panel.'
Mitochondrial diseases are caused by faulty mitochondria that cause incurable, progressive failure in tissues such as the brain, heart and muscles. As mitochondria are passed on solely from the mother via the cytoplasm of the egg cell, MRT involves replacing the faulty mitochondria of the egg with healthy mitochondria from a donor egg.
A team of specialists at Newcastle University, where the technique was pioneered, is expected to be the first to be granted a licence. They hope to treat up to 25 women per year. The NHS has said it will provide £8 million in funding for a five-year clinical trial.
Mary Herbert, Professor of Reproductive Biology at Newcastle University, said: 'We welcome today's decision from the HFEA, and it is enormously gratifying that our many years of research in this area can finally be applied to help families affected by these devastating diseases.'
After applying for a licence to carry out the procedure, a second licence will need to be obtained for each patient, who will be reviewed on a case-by-case basis.
Professor Sir Mark Walport, the government's Chief Scientific Adviser, said: 'I welcome this careful and considered assessment by the HFEA. The UK leads the world in the development of new medical technologies. This decision demonstrates that, thanks to organisations like the HFEA, we also lead the world in our ability to have a rigorous public debate around their adoption.'
The world's first mitochondrial donation baby was born in a clinic in Mexico earlier this year, where no national laws currently exist to regulate the practice. The medical director of the clinic, Dr Alejandro Chávez Badiola, has recently announced plans to treat 20 more women in the first half of 2017.
SOURCES & REFERENCES
Babies made from three people approved in UK
BBC News | 15 December 2016
Controversial 'three-parent baby' technique given go-ahead in historic decision
The Independent | 15 December 2016
First UK baby with DNA from three people could be born next year
The Guardian | 15 December 2016
Three parent babies: IVF clinics told they can create children with two mothers
The Telegraph | 15 December 2016
UK becomes first country to give go ahead to three-parent babies
New Scientist | 15 December 2016
© Copyright Progress Educational Trust
Reproduced with permission from BioNews, an email and online sources of news, information and comment on assisted reproduction and genetics.
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15 January 2017
Fact Sheet 1. Re: Not Suitability Of Mitochondria Injection Into Human Eggs To Produce Babies
1. Point 1,2,3,5,6,7 in the “Fact Sheet Re: Not Suitability of Ooplasm Transfer” (submitted by Ke-Hui Cui to FDA on Dec.22, 1999) are still suitable for this fact sheet.
2. Human mitochondria DNA contain 37 genes, in which 13 genes involve producing energy (ATP). The remaining genes provide instructions for making amino acids into proteins. The types and ratio of these genes and their dosage in human eggs are important to be remained to avoid any kind of mitochondrial diseases. Mitochondria injection (including autologous injection) will change the types and ratio of these different mitochondrial genes and their dosage, which will lead to hereditary mitochondrial diseases.
3. Mutation rate of mitochondria is higher than that of nuclear DNA if human cells are under abnormal condition or even under normal condition. Any in vitro procedures including cultured cells and any extraction procedures or reagents will easily lead to mitochondria DNA mutation as which will lead to nuclear DNA mutation. Injection of those mitochondria with mutation will lead to higher rate of hereditary diseases.
4. The incomplete reprogramed eggs and their precursor cells (or egg stem cells) are full of mitochondria with abnormal methylation condition and abnormal histone code. Injection of reprogramed mitochondria will lead to genetic diseases.
5. Mitochondria injection in eggs may not change energy supply in the eggs due to most mitochondrial regulators to be controlled by nuclear DNA rather than by mitochondria DNA itself.
6. Mitochondria injection in the eggs will lead to babies’ phenotype to be changed. The main reason is: anything influences the eggs or sperm will lead to changes in the babies’ phenotype. Detailed reason are:
A. Environmental change can change phenotype of human being even after birth. The characteristics of human sperm are getting worse in recent 20 years is an obvious example.
B. Food and medicine can change phenotype of human being before birth. Lack of folic acid will lead to fetal abnormality is an example.
C. Environmental change can change phenotype of human being at the embryonic stage. Water and air quality, temperature, pH, amino acid, ion concentration, etc. will change embryo development, including DNA degeneration, cell number and embryo morphology, etc.
D. Any change happened in germ cells will change phenotype of human being. PVP used in ICSI (Intracytoplasm Sperm Injection) injected into the eggs will lead to sex chromosome abnormalities in babies is an example. Also, more human albumin in ICSI into the human eggs will lead to worse embryo development is another example. If injecting genes into the human eggs, hereditary diseases will follow.
E. The phenotype sensitivity to any change in human being is: the younger, the more sensitive. Sensitivity: Egg>Sperm>Embryo>fetus>babies> adults.
7. There is feedback system in egg stage, as the same as in embryonic stage and after birth (hormone feedback system). Proteins, RNA and DNA in ooplasm will commute with nuclear DNA, to let nuclear DNA to re-control the concentration and function of proteins, RNA and DNA again. Embryos in no calcium and magnesium medium during embryo biopsy over 30 minutes will lead to the born baby mice with higher blood calcium and magnesium is a good example of feedback results. Injection with mitochondria into the eggs will lead to the nuclear DNA recognizes too much of mitochondria, thus regulates to produce less mitochondria in babies, which will lead to the babies to get mitochondrial diseases. There are 37 mitochondria genes. Thus mitochondria injection into the eggs will lead to more than 37 kinds or up to different combination of mitochondrial diseases.
8. Mitochondrial diseases usually are late-onset diseases, which include different kinds of cancer, neuropathy, diabetes, epilepsy, deafness, growth development problem, function problems of heart, brain and muscles, and etc. They are rare diseases, and hard to be diagnosed and hard to be treated.
9. For the aim to solve patient’s infertile problem, it is not worth changing human being.
10. In reverse, if the future daughter of babies from mitochondria injection wishes to change back to normal mitochondria condition as her grand mom’s mitochondrial condition, can OvaScience help her to solve her problem? Her problem is more severe than the infertile problem. OvaScience can not help her to solve the genetic problems which OvaScience created. How about the daughter’s offspring and offspring? No hope. Disaster!!! Human being has been changed and can not be changed back to be normal.
This is a part of letter sent to U.S. FDA Director on March 22, 2013, RE: Protect Human beings in Heredity by Ke-Hui Cui, M.D., Ph.D.
Please also read:
1. “CHANGING HUMAN BEINGS BY MRT IS MISLEADING AND NOT SCIENTIFIC” published on ivf.net 05 December 2016 comment for “Expert panel approve cautious use of mitochondrial donation in the UK” response on 19 December 2016.
2. “HUMAN BEINGS SHOULD NOT BE CHANGED IN HEREDITY” published on ivf.net 18 October 2016 comment for “Mitochondrial replacement therapy and the welfare of the child” response on 02 November 2016.
3. “CHANGING HUMAN BEINGS IN HEREDITY IS MISLEADING AND INFAMOUS” published on ivf.net 01 November 2016 comment for “ ‘Three-person babies’ grow up into healthy teenagers” response on 07 November 2016.
4. “Fact Sheet 2. Re: Not Suitability To Use Artificially Created, Modified Or Reprogrammed Human Eggs (Or Sperm) To Produce Babies” published on ivf.net 25 October 2016 comment for “Functional mouse eggs made from artificial stem cells” response on 11 November 2016.