To evaluate the Italian physicians' knowledge/information level about the therapeutic potential of stem cells, the research choice between embryonic and cordonal stem cells, and the preference between autologous and heterologous storage of cordonal stem cells, we performed a national survey. The questionnaire—distributed to 3361 physicians—involved physicians of different religious orientations and of different medical specialities. Most of the physicians involved (67%) were Catholics, and the majority were gynaecologists and paediatricians (43%) who are mainly in charge to inform future mothers about the possibility of cordonal stem cells conservation. The majority of the physicians interviewed do not have specific knowledge about stem cells (59%), most of them having only generic information (92%). The largest part of physicians prefer to use umbilical cord blood cells rather than embryonic stem cells. Nevertheless, a large percentage of physicians were in favour of embryo research, especially when embryos are supernumerary (44% versus 34%). Eighty-seven % of the physicians interviewed proved to have a general knowledge about stem cells and believe in their therapeutic potential. They prefer research on cordonal stem cells rather than on embryo stem cells. Although they are in favour of heterologous stem cells donation, they still prefer cryopreservation for personal use.
Stem cells research is recently reproposing the paradigmatic case of the reciprocal influence between science and ideological (e.g., political, religious, economic, and social) issues. More specifically, an important question deals with the impact upon national regulation and social behaviours of the scientific community experts’ advice regarding stem cells research and its exploitation for health care purposes. Stem cell-based therapies, exploited in different clinical scenarios, have been recently the key matter of an important debate in the Italian as well as in the international scientific community due to the case of Stamina Foundation. Translational medicine thus represents a stem of scientific research that aims to move “from bench to bedside” or from laboratory experiments through clinical trials to point-of-care patient applications. The “prevalent theme” of this stem of research is without doubt represented by the regenerative medicine, with all the stem cell-based approaches corresponding to the zenith of the epiphenomena [
This represents one of the most recent examples of the conflict which may occur between science and political and sociocultural issues [
To this regard, a scientific, ethical, and political debate is recently reviving in Italy about the utilization of stem cells in regenerative medicine. In this debate, considerable differences of opinion exist depending on the derivation of the stem cells themselves: “adult” stem cells which are found in a variety of tissues in the foetus and after birth (more specialized “multipotent” cells with an important function in tissue replacement and repair) and embryonic stem cells (hESC) which can only be derived from preimplantation embryos (“pluripotent” cells which have the ability to form cells of all tissues of the adult organism and could be used to develop cell-based therapies) [
The lawfulness of the research concerning the clinical employment of stem cells derived from adult tissues or from the umbilical cord (either from spontaneously or voluntarily aborted foetuses) would not seem to raise insurmountable questions. However, the question about the use of hESC appears charged with deeper ethical tensions.
The debate about human preimplantation embryos for research on ESC and using of umbilical cord blood stem cells has been reported to involve scientists, including the expert ones actively operating in this specific field of research. Poor information has been however reported on the attitudes of medical professionals (e.g., physicians) who are closer to patients or to the public opinion than specialized research scientists.
Fast forward to current evidence-based practice concerning translational medicine applied to organ’s regeneration and exploited by different stem cell, our analysis can provide better insights into the more direct impact that these issues have on professional choices or into their influence on the patients’ choice (e.g., about pursuing the alternative of nationally permitted therapeutic strategies or choosing more permissive countries to afford suitable stem cell therapies).
To this aim, we investigated the opinion of 3361 Italian physicians about the use of human embryos generation for isolation of hESC, about the stem cells clinical potential, and about related ethical and juridical issues.
The survey, self-administered and anonymous, was performed through an e-mail based questionnaire sent to a sample of 3361 physicians, males and females, aged from 30 to 70 years (Table
Participants’ general information.
Participants | Age (years) | Sex (%) | Religion (%) |
---|---|---|---|
Respondent (377 : 3.361—11%) | 30–70 | M (48.2) | Catholic (56) |
F (51.8) | Other (44) | ||
Nonrespondent (2.984 : 3.361—89%) | 30–65 | M (68.8) | Catholic (71) |
F (31.2) | Other (29) |
The physicians involved worked in all areas of medicine (gynaecology and obstetrics, psychiatry, surgery, forensic medicine, paediatrics, dentistry, neonatology, and anaesthesiology). Physicians who do not normally deal with stem cell-based treatments have been surveyed. Special attention was given to gynaecologists and paediatricians, since they are in charge of the information delivered to future mothers about the possibility of cryopreserving their own son stem cells (Table
Participants’ medical specialties.
Respondents | Nonrespondents | ||
---|---|---|---|
Gynaecology and obstetrics | (43%) | Hygiene | (0%) |
Paediatrics | (41%) | Pathology | (0%) |
Psychiatry | (1%) | Minor surgery | (0%) |
Surgery | (1%) | Radiology | (0%) |
Forensic medicine | (1%) | Geriatric medicine | (0%) |
Dentistry | (1%) | Pathology | (0%) |
Anaesthesia | (1%) | Ophthalmology | (0%) |
Orthopaedics | (0%) | ||
Cardiology | (0%) |
Specifically, the questionnaire develops 14 points concerning the following areas: (i) knowledge and opportunities of human embryonic stem cells research; (ii) attitudes/opinions about hESC research; (iii) umbilical cord blood cells explant and storage techniques; (iv) differences between heterologous and autologous storage; (v) opportunity to donate surplus embryos actually stored for research purposes (Table
The questionnaire.
Questions | Yes | No | Do not know |
---|---|---|---|
(1) Do you have a generic knowledge of stem cells? | 92% | 4% | 4% |
(2) Do you have a specific knowledge of stem cells? | 31% | 59% | 10% |
(3) Are you aware of the potential therapeutic applications with stem cells? | 86% | 7% | 7% |
(4) Did you ever attend vocational and training courses or meetings regarding stem cells? | 29% | 65% | 6% |
(5) Would you be interested in developing your knowledge about stem cells? | 70% | 15% | 15% |
(6) Are you aware of the possibility to isolate stem cells from embryos (with their sacrifice), human tissues, and umbilical cord? | 92% | 3% | 5% |
(7) Do you agree with human embryo research? | 34% | 45% | 21% |
(8) Do you agree with human supernumerary embryo research? | 44% | 40% | 16% |
(9) Would you prefer the explant of stem cells from umbilical cord rather than from embryos in case this option would be legal? | 87% | 3% | 10% |
(10) Did you personally receive information about the explant methods of umbilical cord stem cells? | 47% | 47% | 6% |
(11) Do you know the Italian legislation about the explant and conservation of umbilical cord stem cells? | 51% | 40% | 9% |
(12) Do you know the difference between autologous and heterologous conservation of umbilical cord stem cells? | 54% | 38% | 8% |
(13) Would you donate part of your child’s umbilical cord stem cells for therapeutic and research purposes? | 91% | 2% | 7% |
(14) Would you conserve your child’s umbilical cord stem cells for personal and therapeutic purposes? | 73% | 16% | 11% |
Descriptive and inferential statistical data was performed. In particular, both the frequency and percentage of each type of reply for the different categories were calculated. A bivariate evaluation was then carried out in order to analyse the relationship between pairs of variables. The Chi square test was especially used for investigating significant statistical differences between categorical variables; a
In particular, we have analysed the relationship between religion and the responses to the questionnaire, including medical area of belonging and answers, and also between certain pairs of responses thought to be more interesting to compare.
The questionnaire was distributed to 3361 physicians and 377 completed surveys were received. The response rate was 11% and 88% of the respondents were aged from 47 to 59 years. Forty-three % (
Participants’ religious attitudes.
Religion | % |
|
---|---|---|
Catholics | (56%) | 210 |
Atheists (agnostics) | (9%) | 35 |
Jews | (1%) | 2 |
Other | (2%) | 6 |
Unknown | (21%) | 79 |
Even the participation in conferences or training courses is the prerogative of the gynaecologists (44% versus 20% of paediatricians and 20% of other medical areas).
The vast majority of gynaecologists also personally received information/communication methods on the harvesting procedure of stem cells from umbilical cord (78% gynaecologists versus 30% paediatricians and 22% of other physicians,
For the other questions, there are no statistically significant differences in respect to the medical areas of specialty.
Regarding the relationship between religious belief and the answers to these specific questions, we found statistically significant differences with the question regarding the preference about the research/experimentation on human embryos. It is noticeable that doctors of other religions are more prone to this type of research (56%) than Roman Catholic doctors (31%). The relationship between religion and the question regarding the opinion on the research/experimentation on supernumerary human embryos is statistically significant (
Only the 41% of catholic doctors agree with human embryo research with a high propensity towards the use of supernumerary human embryos.
For the other questions, there are no statistically significant differences regarding religious belief.
The analysis demonstrated that the majority of the physicians interviewed did not have specific knowledge on stem cells (59%;
We noted moreover that, among doctors who have specific knowledge about stem cells, 98% declared to be “aware of the possible therapeutic applications,” while among doctors who do not have specific knowledge about stem cells 90% are aware of the therapeutic potentiality (
Fifty-four % of physicians who “have specific knowledge about stem cells” participated in conferences/seminars/training courses with sessions on stem cells, while only 19% without specific knowledge about stem cells participated in conferences (
We observed a statistically significant difference (
The survey showed how embryonic stem cells research continues to be a tricky question. Accordingly, the majority of the physicians involved (87%;
Human embryo research.
Human supernumerary embryo research.
We observed statistically significant differences between the two questions related to the opinion more or less “conducive to research/experimentation on human embryos” and “supernumerary embryos” (
Most of the physicians involved had only general information about stem cells supply. Ninety-two % of them only had knowledge of the possibility to isolate stem cells both from human embryos and from umbilical cord, lacking instead specific information about the techniques and the legislation.
Indeed, about a half (47%;
Italy has adopted very strict rules on the use of both human preimplantation embryos for research on ESC and umbilical cord blood stem cells, also expressly prohibiting the creation of human embryos for research or experimentation purposes. In Italy, the legal protection of the embryo is regulated since 2004 by the law on medical assisted reproduction (Law 40/2004), which, with a few concise and peremptory words, is to “liquidate” one of the emerging questions in scientific research. Such an extensive and complex subject—it is sufficient to stress once again the different implications of the various research technologies: cloning; adult stem cells; foetal stem cells; and embryonic stem cells—would require an appropriately complex law [
The export of stem cells (even if they are harvested in Italy) for personal purposes is allowed at the expenses of the applicant after obtaining a ministerial authorization (art. 2, 9th paragraph, Ministerial Decree n. 42886/2009) [
The aim of this study is to evaluate and analyse Italian physicians’ knowledge and information level about the scientific and therapeutic potential of stem cells and to verify their inclination between embryonic and cordonal stem cell research. Despite their difference from hESC, cordonal stem cells are considered to be a valid therapeutic alternative. Moreover, the aim of this study is to evaluate and analyse physicians’ attitudes towards the scientific and therapeutic utilization of stem cells and finally to verify which type of correlation exists between the current Italian legislation and the physicians’ opinions. Regardless of the complexity of ethical implications, the survey revealed a good understanding of the benefits of stem cells research by the physicians. Ethical and juridical implications of stem cells utilization significantly depend on their source (skin, blood, embryo, etc.). Every biological source involves different criticality levels and normative difficulty.
Human embryo research still represents a particularly controversial and complex matter [
However, every invasive treatment to the embryo not aimed to diagnostic and therapeutic purposes is prohibited. The balance between the freedom of science and the embryo’s health protection is settled in favour of the embryo. Our survey shows that the current legislation appears consistent with the opinion of 45% physicians interviewed (who did not favour human embryo research). Thus we can assume that the embryos come first, even when faced with the advancements of research.
The relatively high percentage of physicians in favour of embryos’ use (34% and 44% for supernumerary embryos’ use) demonstrates that several physicians believe in the potential of embryonic stem cells research, approving the embryo’s sacrifice for protecting public health. The increased percentage (44%) in favor of using spare embryos could be justified by the minor disvalue that is generally attributed to the sacrifice of nonimplantable embryos. In contrast, the high percentage of abstentions (21% for embryos and 16% in case of supernumerary embryos) suggests that a still consistent fraction of the population of physicians lacks the perception of the importance of these issues and has little information and awareness about the benefits of the use of human embryos for research purposes.
The last decade of Italian debate about the embryo’s condition and health has been changing.
At the beginning, Dulbecco’s Commission provided a very open opinion on the donation of supernumerary embryos (Principle of beneficence) [
Furthermore, in 2007, the above committee performed a study regarding the destiny of the embryos coming from ART and not implantable, recalling the need for determining criteria for the ascertainment of the embryo’s death, in order to make the donation of stem cells for scientific purposes possible [
According to European legislation, the dispute between the embryos’ production and utilization has been resolved by article 18, first paragraph, of the Convention on Human Rights and Biomedicine (1997), which prohibits the creation of human embryos for research purposes (art. 18, 1st comma, provides that “Where the law allows research on embryos in vitro, it shall ensure adequate protection of the embryo”) [
According to a comparative approach, we can classify juridical models on embryos research into two main types: “value oriented,” characterized by very restricted rules aimed to guarantee the embryo preservation [
Some countries opted for very strict embryo’s protection legislation, prohibiting every treatment not aimed at diagnostic and therapeutic purposes according to the first model (e.g., Austria and Poland) [
Very liberal models occur in countries such as Spain, UK, Belgium, Sweden, Czech Republic, Greece, and Switzerland where the creation/use of embryos is allowed for research purposes under strict conditions, on the basis of the authorization and the monitoring of technical bodies. Clearly, UK represents one of the most liberal existing models in the European area, in which the Human Fertilisation and Embryology Act, dated on 1990—as modified by the further Human Fertilisation and Embryology Act (2001)—allows the use of embryos for research purposes as well as the therapeutic cloning [
In our survey, the high percentage of abstentions, 21% for embryos and 16% in case of supernumerary embryos, suggests the existence of a widespread detachment from some issues and also of misinformation and lack of awareness about the benefits of hESC based research.
The opportunity and the lawfulness of human embryos utilization for research purposes must be evaluated not only with regard to ethical principles but also according to a solidarity and collective convenience [
However, at international level we notice, as already highlighted, a progressive opening towards supernumerary embryos research. The Convention on Human Rights and Biomedicine leaves in fact wide freedom to member States in order to decide about allowing hESC utilization underlining, at the same time, the importance and necessity of guaranteeing an adequate protection of embryos’ health. Recently, the Court of Justice of the European Union also confirmed the necessity to avoid embryos destruction. In a judgment, the Court established that drugs arising from research on hESC cannot be patented [
By an ethical point of view, our survey confirms that the use of adult stem cells is difficult. Most of the physicians interviewed (87%) opted for cord blood cells rather than embryonic stem cells supply. Furthermore, most of them (73%) are in favour of autologous conservation considering its usefulness for therapeutic purpose, while only 16% are against it and 11% have no opinion on this issue. These results highlight that physicians trust the high benefits of umbilical cord stem cells and, at the same time, show how the current juridical frame (based on a greater protection of heterologous explant for solidarity purposes) does not appear to reflect the physicians’ position. Physicians are consistently in favour of autologous explant considering it useful in order to safeguard their child’s health.
However, as mentioned above, the Italian legislation on umbilical cord stem cells use is very strict, allowing the autologous storage only in peremptorily predetermined cases. After all, in Italy, the debate on adult stem cells storage is focused on two main issues: the “health protection”—the utilization of stem cells must represent a therapeutic protection for the individual use of the donor—and the “solidarity principle”—the use of stem cells must be a therapeutic protection at the whole community’s disposal.
The resolution of the main juridical issues on stem cells research, both adults and embryonic, involves the requirement of balancing several interests issued from rights and freedoms protected by the Italian Constitution such as the right of health (art. 32 Const.), science freedom (art. 33 Const.), the promotion of scientific research (art. 9 Const.), and the freedom of economic initiative (art. 41 Const.). If on one hand the utilization of human cells could represent a solidarity act, on the other hand it could bring, to the exploitation of the human being for economic purposes, despising human dignity.
The current survey finally shows that the scientific misinformation and the influence of certain religious orientations affect the physicians’ decision-making process. The lack of information does not concern only the scientific-therapeutic aspects but also the juridical ones: forty-nine % of physicians, in fact, appear to be misinformed about the Italian law on this matter. The lack of a suitable knowledge underlines not only the need for a wider diffusion of scientific information on this topic (e.g., through public initiatives aimed to create awareness in health care providers) but also the need for harmonizing Italian legislation with the other countries. Finally, participants’ responses might be influenced by their religious orientation (most of the physicians involved were Catholic (56%)) since, in the scenario that animates the current Italian debate on these matters, the position held with particular emphasis by the exponents of the Catholic ethics appears stronger even with respect to other Catholic countries, like Spain, which have adopted an intermediate public policy on hESC and cloning research [
Eighty-seven % of the physicians interviewed, before a concrete alternative, gave their preference to umbilical cord stem cells rather than to hESC. However, when we asked the physicians about the opportunity to use human embryos for isolation of hESC without a concrete alternative, we registered an increase in the percentage of favourable answers (34% for embryos and 44% for supernumerary embryos). The current study suggests that today the religious influence on the physicians’ decision-making process is not based any more on an
Data reveal the importance of improving knowledge and information about the therapeutic and research potential of stem cells [
Information about cryopreservation of cordonal stem cells is especially critical in gynaecologists and paediatricians since they are the main stem informer from physicians to future mothers. Sadly, the Italian percentage of cryopreserved cordonal stem cells is particularly low.
Although an appropriate scientific and technical knowledge of the matter is still lacking, ethical and juridical implications represent the major obstacle to embryonic stem cells research interfering with health care professionals’ decisions. This is mainly due to the Italian cultural background based on historical reasons and on specific religious orientations currently involving Italian physicians. These orientations have an impact on the current and future Italian juridical system [
In conclusion, we believe that human beings have the right to be informed in order to take decisions concerning their body parts, their biological tissues collection, and their relative destination and utilization [
The authors declare that there is no conflict of interest regarding the publication of this paper.
Paola Frati and Matteo Gulino planned and designed the study. Stefano D’Errico was responsible for most of the data acquisition. Lorella Sicuro performed the statistical analysis. Arianna Pacchiarotti and Matteo Gulino performed the literature research. Paola Frati, Matteo Gulino, and Vittorio Fineschi analysed the data and were primarily responsible for writing the paper. All authors were involved in drafting and revising the paper.
The authors wish to thank CONSULCESI for technical assistance.