Desideria Mini

Demand European Union to fund the research on embryonic stem cells and on genome modification in germ-line

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We, citizens of different countries, believe that the criteria for funding biomedical scientific research must consider all those researches that can protect and promote scientific progress in the treatment of ...Read More

We, citizens of different countries, believe that the criteria for funding biomedical scientific research must consider all those researches that can protect and promote scientific progress in the treatment of serious diseases in order to guarantee the primary interest of patients and future generations of Mankind.

Therefore European institutions should not exclude a priori funding for the most promising frontiers of medicine and biology like studies about regenerative therapies (those are researches that try to develop methods to regrow, repair or replace damaged or diseased cells, tissues or organs, including generation and use of therapeutic stem cells, tissue engineering and the building of artificial organs) or about preventive medicine in the future of medically assisted procreation.

Scientific evidences show that research on embryonic stem cells and on human embryos with related genome editing are among the most promising techniques respectively to find cures for several types of severe diseases and to prevent inheritable ones in the offspring.

For these reasons we think the article 14 of the Horizon Europe proposal for funding research in the European Union from 2021 to 2027 must be changed.

The use of embryonic stem cells was effective both in preclinical trials for the treatment of neurodegenerative diseases in Lund, Cambridge and New York, where the clinical phase ought to start soon, and in clinical trials on blindness due to diseases in the retinal macula in London where several patients have recovered their sight. The respectively encouraging and excellent results of these researches have shown the effective therapeutic usefulness of the totipotent or pluripotent cells such as those of the embryo.

Unfortunately, due to the patient's immune response, it is not always possible to resort to stem cells extracted from supernumerary embryos (embryos left by medically assisted procreation cycles).

However the transfer of the nucleus of a somatic cell of a patient into an egg cell deprived of its nuclear genetic material would allow the production of embryonic stem cells compatible with the patient's own immune system, in order to avoid the transplant rejection.

So, for not to limit the research of effective treatments and the application of the valid therapies that derive from it, we believe that funding should also be allowed including the somatic cell nuclear transfer for the purpose of stem cell procurement.

We also think the article 14 of the Horizon Europe proposal for funding research should not exclude activities intended to modify the genetic heritage of human beings, which could make such changes inheritable, when these are carried out for preventive purposes.

About 8000 monogenic diseases are known and each individual, often without knowing it, is a carrier of various mutations that can cause a genetic disease.

Today, fortunately, the new medical advances sometimes allow people affected by a hereditary genetic disease which reveals itself (or which anyway revealed itself) at young age to live (longer) and have a healthier life and this often allows them also to get to have children. Thank to research, in the future, this will be even more true, and for an increasingly number of hereditary genetic diseases. Obviously all that is a good news but this also means that harmful genetic variants are and will be always passed to children and therefore (also) to future generations.

So, due to medicine, natural selection is and will be missing in human species. This will have serious consequences, especially in the long term. Indeed the harmful genetic mutations inevitably accumulate in the absence of the natural selection, because harmful mutagenic events occur more frequently than beneficial ones. So, considering all that, about those (many) hereditary genetic diseases whose onset occurs (or may also occur) before or during the usual reproductive period of the individual's life, it is more than predictable that, moreover, their incidence in the human population over the generations will tend to increase, even up to a "point of unsustainability".

Similar principle apply to chromosomal diseases.

Unfortunately, pre-implantation genetic analysis of embryos (on its own) has limits that do not always make it sufficient or useful to deliver a "healthy" child and, in any case, a child not carrier of a dangerous genetic or chromosomal variant inherited from her\his parents and, in turn, transmissible to her\his future children. For people carrying a genetic disease who wish a child, the pre-implantation genetic analysis of embryos in order not to transmit the harmful genetic variant is usefull when both partners of a couple are heterozygous for a - recessive or not-recessive - genetic disease or when a person is heterozygous for a not-recessive genetic disease but it may be insufficient as the number of non-carrier embryos produced by in vitro fertilization may be low or zero, like it happens often, while, for the same purpose, it is useless when a person is homozygous for the genetic disease. The pre-implantation genetic analysis of embryos for the only outcome of giving birth to a "healthy" child is useful when at least one partner of a couple is heterozygous for a recessive genetic disease but it may be insufficient as even the total number of embryos "suitable for a pregnancy" may sometime be low or zero, while, for the same result, it is useless when both partners are homozygous for the recessive genetic disease and when a person is homozygous for a not-recessive genetic disease. To face the problem of the insufficiency of the "valid" embryos number, and only for that, the cycles of in vitro fertilization and pre-implantation genetic analysis can be repeated, nevertheless there is no certainty but only the probability of reaching the aforementioned objectives and so, in some cases, these can even never be reached.

The polar bodies biopsy is even more limiting because it allows the selection of genetic or chromosomal makeup coming only from female gametes, does not exclude possible cases of gene conversion, and is completely useless in case of aspiring mother's homozygosity.

(According to the research status, within a "few" years it could be possible to produce normal human sperm in vitro with safety, but selecting the secondary spermatocytes or the spermatids will be very hard due to their cytological features, besides presenting limits analogous to those of polar bodies biopsy.)

However, if appropriate basic research were carried out on human “fertilized oocytes”, zygotes, very early embryos and precursor stem cells of the gametes (on spermatogonia or on reprogrammed induced pluripotent stem cells) one day predictably it may become possible to modify the human genome in hereditary way with safety and efficacy. Only then we could decide whether to apply the results of such research in the clinic to reduce the incidence of hereditary diseases, or at least to stop their spread, still remembering, however, that these researches are first carried out in vitro also on human cells, otherwise this will never be possible.

Indeed we believe that in the future safe and effective inheritable treatments for hereditary diseases should be allowed (and perhaps also encouraged, at least for more serious them) because they would prevent the disease for all the descendants. That would avoid having to cure and heal people for each generation, something of which, moreover, there would be need more and more.

We do not claim that this line of research is superior to others or that research into somatic genetic therapies should not be funded. We just want to say that in vitro research on "germ-line genetic therapies" (in quotation marks because it would be more accurate to speak of "in germ-line genetic prevention by genetic modification") are complementary and very important so that such research should not be excluded a priori from funding.

For all the reasons expressed we also believe that funding should also be allowed whenever it is directed to activities intended to create human embryos and to let them develop within the first fourteen days (excluding the period of eventual cryo-preservation) also solely for the purpose of research, like germ-line genome editing in vitro experiments and genetically edited embryos initial development studies.

In particular, for germ line genome editing experiments, the use of sole supernumerary embryos would be problematic and limiting. The supernumerary embryos are at morulae (eight – sixteen cells) or blastocysts (thirty two – three hundred cells) stages. In these cases to be sure of always and only acting in a beneficial way and also in the germinal line, it would be necessary to genetically modify each of the many cells of the embryo - inner cell mass for the blastocyst - and in a precise, effective and correct way for each cell, and without accidentally damages for every one of them.

Research has shown instead genetically modify the few cells of very early embryos (two cells) is simple and it happen with efficient manner. Early embryos are obtainable from zygotes but the cryopreserved left zygotes are few and nowadays they are no longer frozen because now only morulae and (especially) blastocysts are frozen. So the number of zygotes to have recourse to is low and limited.

Furthermore, the use of (sole) supernumerary embryos would not allow the study of the development of embryos deriving from fertilization with genetically edited gametes (to get through the genome editing of their precursor stem cells).

It is also important that in the future the results of all these researches are shared among the people and benefit the entire world population.

For this reason we also believe that it is wrong to let these researches take place only outside the European Union.

We urge Members of the European Parliament, EU Commissioners and Governmental representatives to revise the criteria for "Eligible actions and ethical principles" for funding biomedical researches of the Horizon Europe 2021 – 2027 in line with the present petition.

So we ask to emend the letters (b) and (c) of Article 14 of the Horizon Europe 2021 – 2027 as follow:

(b) activities intended to modify the genetic heritage of human beings which could make such changes heritable, except for preventive purposes;

(c) activities intended to create human embryos solely for the purpose of research or for the purpose of stem cell procurement, including by means of somatic cell nuclear transfer, if it's planned that embryos develop for more than fourteen days or if there are other valid alternatives.

Finally, we believe that the second part of article 90 of EU Regulation 536/2014 on clinical trials of medical products for human use which prohibits modification of the germline should be retouched.

We understand the precautionary spirit of this part as we agree that the genome editing techniques are not yet ready to be applied to the germ line in the clinic as they still require a long phase of improvement with basic and preclinical experimentation. Nonetheless, we believe there are two valid reasons to slightly weaken such a total and perennial ban.

First, when Regulation 536/2014 enters into force, article 90 will immediately have the perverse effect of blocking also clinical trials of mitochondrial replacement techniques (MRTs), better known to the public as "mitochondrial donation". MRTs (germinal vesicle transfer, spindle chromosome transfer, first polar body transfer, pronuclear transfer and second polar body transfer) are totally different from genome editing. MRTs "by replacing mitochondria replace their DNA without directly altering the sequence (with chemical reactions)" unlike genome editing. MRTs have already successfully passed both basic and preclinical trials. Not only. Some of them have already been tested in the clinic leading to the birth of children. Although there are very few cases, these children are all healthy. MRTs are the only concrete possibility available to date capable of preventing the transmission of mitochondrial DNA related diseases from mother to her children and from her daughters to future generations. MRTs clinical trials must not be blocked.

Second, if and when genome editing becomes safe and effective, it would be useful and right to use it for preventive purposes in the procreative field, especially for nuclear DNA. Instead, for the reasons already expressed, a perennial ban would be senseless and harmful. We believe that a seven-year moratorium would be sufficient, without prejudice for the European Institutions to always be able to extend it or not in the light of the effective advancement of scientific knowledge and techniques.

Therefore we also propose the following reformulation of the second part of article 90 of Regulation 536/2014:

No gene clinical trials may be carried out which result in modifications to the human germline genetic identity before the December 31, 2027, except for the mitochondrial replacement techniques.”

We, the undersigned.

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