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Ke-Hui Cui M.D., Ph.D.

Savannah, Georgia, 31405, U.S.A.

Jan. 15, 2017

Email: khcui72@hereditics.net

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*Comment for "UK approves mitochondrial donation babies", ivf.net, Jan. 1,  2017. 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.

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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.

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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.

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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.

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