SUMMARY: The National Institutes of Health (NIH) is hereby publishing final "National Institutes of Health Guidelines for Human Stem Cell Research" (Guidelines).

On March 9, 2009, President Barack H. Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The Executive Order states that the Secretary of Health and Human Services, through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.

These Guidelines implement Executive Order 13505, as it pertains to extramural NIH-funded stem cell research, establish policy and procedures under which the NIH will fund such research, and helps ensure that NIH-funded research in this area is ethically responsible, scientifically worthy, and conducted in accordance with applicable law. Internal NIH policies and procedures, consistent with Executive Order 13505 and these Guidelines, will govern the conduct of intramural NIH stem cell research.

EFFECTIVE DATE: These Guidelines are effective on July 7, 2009.

SUMMARY OF PUBLIC COMMENTS ON DRAFT GUIDELINES: On April 23, 2009 the NIH published draft Guidelines for research involving hESCs in the Federal Register for public comment, 74 Fed. Reg. 18578 (April 23, 2009). The comment period ended on May 26, 2009.

The NIH received approximately 49,000 comments from patient advocacy groups, scientists and scientific societies, academic institutions, medical organizations, religious organizations, and private citizens. The NIH also received comments from members of Congress. This Notice presents the final Guidelines together with the NIH response to public comments that addressed provisions of the Guidelines.

Title of the Guidelines, Terminology, and Background:

Respondents felt the title of the NIH draft guidelines was misleading, in that it is entitled "National Institutes of Health Guidelines for Human Stem Cell Research," yet addresses only one type of human stem cell. The NIH notes that although the Guidelines pertain primarily to the donation of embryos for the derivation of hESCs, one Section also applies to certain uses of both hESCs and human induced pluripotent stem cells. Also, the Guidelines discuss applicable regulatory standards when research involving human adult stem cells or induced pluripotent stem cells constitutes human subject research. Therefore, the title of the Guidelines was not changed.

Respondents also disagreed with the definition of human embryonic stem cells in the draft Guidelines, and asked that the NIH define them as originating from the inner cell mass of the blastocyst. The NIH modified the definition to say that human embryonic stem cells "are cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers."

Financial Gain

Respondents expressed concern that derivers of stem cells might profit from the development of hESCs. Others noted that because the stem cells eligible for use in research using NIH funding under the draft Guidelines are those cells that are subject to existing patents, there will be insufficient competition in the licensing of such rights. These respondents suggested that this could inhibit research, as well as increase the cost of any future clinical benefits. The Guidelines do not address the distribution of stem cell research material. It is, however, the NIH's expectation that stem cell research materials developed with NIH funds, as well as associated intellectual property and data, will be distributed in accordance with the NIHs existing policies and guidance, including "Sharing Biomedical Research Resources, Principles and Guidelines for Recipients of NIH Grants and Contracts" and "Best Practices for the Licensing of Genomic Inventions." http://www.ott.nih.gov/policy/policies_and_guidelines.aspx Even where such policies are not directly applicable, the NIH encourages others to refrain from imposing on the transfer of research tools, such as stem cells, any conditions that hinder further biomedical research. In addition, the Guidelines were revised to state that there should be documentation that "no payments, cash or in kind, were offered for the donated embryos."

Respondents were concerned that donor(s) be clearly "apprised up front by any researchers that financial gain may come from the donation and that the donor(s) should know up front if he/she will share in the financial gain." The Guidelines address this concern by asking that donor(s) was/were informed during the consent process that the donation was made without any restriction or direction regarding the individual(s) who may receive medical benefit from the use of the stem cells, such as who may be the recipients of cell transplants. The Guidelines also require that the donor(s) receive(s) information that the research was not intended to provide direct medical benefit to the donor(s); that the results of research using the hESCs may have commercial potential, and that the donor(s) would not receive financial or any other benefits from any such commercial development.

IRB Review under the Common Rule

Respondents suggested that the current regulatory structure of IRB review under the Common Rule (45 C.F.R. Part 46, Subpart A) addresses the core ethical principles needed for appropriate oversight of hESC derivation. They noted that IRB review includes a full review of the informed consent process, as well as a determination of whether individuals were coerced to participate in the research and whether any undue inducements were offered to secure their participation. These respondents urged the NIH to replace the specific standards to assure voluntary and informed consent in the draft Guidelines with a requirement that hESC research be reviewed and approved by an IRB, in conformance with 45 C.F.R. Part 46, Subpart A, as a prerequisite to NIH funding. Respondents also requested that the NIH create a registry of eligible hESC lines to avoid burdensome and repetitive assurances from multiple funding applicants. The NIH agrees that the IRB system of review under the Common Rule provides a comprehensive framework for the review of the donation of identifiable human biological materials for research. However, in the last several years, guidelines on hESC research have been issued by a number of different organizations and governments, and different practices have arisen around the country and worldwide, resulting in a patchwork of standards. The NIH concluded that employing the IRB review system for the donation of embryos would not ameliorate stated concerns about variations in standards for hESC research and would preclude the establishment of an NIH registry of hESCs eligible for NIH funding, because there would be no NIH approval of particular hESCs. To this end and response to comments, these Guidelines articulate policies and procedures that will allow the NIH to create a Registry. These Guidelines also provide scientists who apply for NIH funding with a specific set of standards reflecting currently recognized ethical principles and practices specific to embryo donation that took place on or after the issuance of the Guidelines, while also establishing procedures for the review of donations that took place before the effective date of the Guidelines.

Federal Funding Eligibility of Human Pluripotent Cells from Other Sources

Respondents suggested that the allowable sources of hESCs potentially available for federal funding be expanded to include hESC lines from embryos created expressly for research purposes, and lines created, or pluripotent cells derived, following parthenogenesis or somatic cell nuclear transfer (SCNT). The Guidelines allow for funding of research using hESCs derived from embryos created using in vitro fertilization (IVF) for reproductive purposes and no longer needed for these purposes, assuming the research has scientific merit and the embryos were donated after proper informed consent was obtained from the donor(s). The Guidelines reflect the broad public support for federal funding of research using hESCs created from such embryos based on wide and diverse debate on the topic in Congress and elsewhere. The use of additional sources of human pluripotent stem cells proposed by the respondents involve complex ethical and scientific issues on which a similar consensus has not emerged. For example, the embryo-like entities created by parthenogenesis and SCNT require women to donate oocytes, a procedure that has health and ethical implications, including the health risk to the donor from the course of hormonal treatments needed to induce oocyte production.

Respondents noted that many embryos undergo Pre-implantation Genetic Diagnosis (PGD). This may result in the identification of chromosomal abnormalities that would make the embryos medically unsuitable for clinical use. In addition, the IVF process may also produce embryos that are not transferred into the uterus of a woman because they are determined to be not appropriate for clinical use. Respondents suggested that hESCs derived from such embryos may be extremely valuable for scientific study, and should be considered embryos that were created for reproductive purposes and were no longer needed for this purpose. The NIH agrees with these comments. As in the draft, the final Guidelines allow for the donation of embryos that have undergone PGD.

Donation and Informed Consent

Respondents commented in numerous ways that the draft Guidelines are too procedurally proscriptive in articulating the elements of appropriate informed consent documentation. This over-reliance on the specific details and format of the informed consent document, respondents argued, coupled with the retroactive application of the Guidelines to embryos already donated for research, would result in a framework that fails to appreciate the full range of factors contributing to the complexity of the informed consent process. For example, respondents pointed to several factors that were precluded from consideration by the proposed Guidelines, such as contextual evidence of the consent process, other established governmental frameworks (representing local and community influences), and the changing standards for informed consent in this area of research over time. Respondents argued that the Guidelines should be revised to allow for a fuller array of factors to be considered in determining whether the underlying ethical principle of voluntary informed consent had been met. In addition to these general issues, many respondents made the specific recommendation that all hESCs derived before the final Guidelines were issued be automatically eligible for Federal funding without further review, especially those eligible under prior Presidential policy, i.e., "grandfathered." The final Guidelines seek to implement the Executive Order by issuing clear guidance to assist this field of science to advance and reach its full potential while ensuring adherence to strict ethical standards. To this end, the NIH is establishing a set of conditions that will maximize ethical oversight, while ensuring that the greatest number of ethically derived hESCs are eligible for federal funding. Specifically, for embryos donated in the U.S. on or after the effective date of the Guidelines, the only way to establish eligibility will be to either use hESCs listed on the NIH Registry, or demonstrate compliance with the specific procedural requirements of the Guidelines by submitting an assurance with supporting information for administrative review by the NIH. Thus, for future embryo donations in the United States, the Guidelines articulate one set of procedural requirements. This responds to concerns regarding the patchwork of requirements and guidelines that currently exist.

However, the NIH is also cognizant that in the more than a decade between the discovery of hESCs and today, many lines were derived consistent with ethical standards and/or guidelines developed by various states, countries, and other entities such as the International Society for Stem Cell Research (ISSCR) and the National Academy of Sciences (NAS). These various policies have many common features, rely on a consistent ethical base, and require an informed consent process, but they differ in details of implementation. For example, some require specific wording in a written informed consent document, while others do not. It is important to recognize that the principles of ethical research, e.g., voluntary informed consent to participation, have not varied in this time period, but the requirements for implementation and procedural safeguards employed to demonstrate compliance have evolved. In response to these concerns, the Guidelines state that applicant institutions wishing to use hESCs derived from embryos donated prior to the effective date of the Guidelines may either comply with Section II (A) of the Guidelines or undergo review by a Working Group of the Advisory Committee to the Director (ACD). The ACD, which is a chartered Federal Advisory Committee Act (FACA) committee, will advise NIH on whether the core ethical principles and procedures used in the process for obtaining informed consent for the donation of the embryo were such that the cell line should be eligible for NIH funding. This Working Group will not undertake a de novo evaluation of ethical standards, but will consider the materials submitted in light of the principles and points to consider in the Guidelines, as well as 45 C.F.R. Part 46 Subpart A. Rather than grandfathering, ACD Working Group review will enable pre-existing hESCs derived in a responsible manner to be eligible for use in NIH funded research.

In addition, for embryos donated outside the United States prior to the effective date of these Guidelines, applicants may comply with either Section II (A) or (B). For embryos donated outside of the United States on or after the effective date of the Guidelines, applicants seeking to determine eligibility for NIH research funding may submit an assurance that the hESCs fully comply with Section II (A) or submit an assurance along with supporting information, that the alternative procedural standards of the foreign country where the embryo was donated provide protections at least equivalent to those provided by Section II (A) of these Guidelines. These materials will be reviewed by the NIH ACD Working Group, which will recommend to the ACD whether such equivalence exists. Final decisions will be made by the NIH Director. This special consideration for embryos donated outside the United States is needed because donation of embryos in foreign countries is governed by the laws and policies of the respective governments of those nations. Although such donations may be responsibly conducted, such governments may not or cannot change their national donation requirements to precisely comply with the NIH Guidelines. The NIH believes it is reasonable to provide a means for reviewing such hESCs because ethically derived foreign hESCs constitute an important scientific asset for the U.S.

Respondents expressed concern that it might be difficult in some cases to provide assurance that there was a "clear separation" between the prospective donor(s) decision to create embryos for reproductive purposes and the donor(s) decision to donate the embryos for research purposes. These respondents noted that policies vary at IVF clinics, especially with respect to the degree to which connections with researchers exist. Respondents noted that a particular clinics role may be limited to the provision of contact information for researchers. A clinic that does not have any particular connection with research would not necessarily have in place a written policy articulating the separation contemplated by the Guidelines. Other respondents noted that embryos that are determined not to be suitable for medical purposes, either because of genetic defects or other concerns, may be donated prior to being frozen. In these cases, it is possible that the informed consent process for the donation might be concurrent with the consent process for IVF treatment. Respondents also noted that the initial consent for IVF may contain a general authorization for donating embryos in excess of clinical need, even though a more detailed consent is provided at the actual time of donation. The NIH notes that the Guidelines specifically state that consent should have been obtained at the time of donation, even if the potential donor(s) had given prior indication of a general intent to donate embryos in excess of clinical need for the purposes of research. Accordingly, a general authorization for research donation when consenting for reproductive treatment would comply with the Guidelines, so long as specific consent for the donation is obtained at the time of donation. In response to comments regarding documentation necessary to establish a separation between clinical and research decisions, the NIH has changed the language of the Guidelines to permit applicant institutions to submit consent forms, written policies or other documentation to demonstrate compliance with the provisions of the Guidelines. This change should provide the flexibility to accommodate a range of practices, while adhering to the ethical principles intended.

Some respondents want to require that the IVF physician and the hESC researcher should be different individuals, to prevent conflict of interest. Others say they should be the same person, because people in both roles need to have detailed knowledge of both areas (IVF treatment and hESC research). There is also a concern that the IVF doctor will create extra embryos if he/she is also the researcher. As a general matter, the NIH believes that the doctor and the researcher seeking donation should be different individuals. However, this is not always possible, nor is it required, in the NIH's view, for ethical donation.

Some respondents want explicit language (in the Guidelines and/or in the consent) stating that the embryo will be destroyed when the inner cell mass is removed. In the process of developing guidelines, the NIH reviewed a variety of consent forms that have been used in responsible derivations. Several had extensive descriptions of the process and the research to be done, going well beyond the minimum expected, yet they did not use these exact words. Given the wide variety and diversity of forms, as well as the various policy, statutory and regulatory obligations individual institutions face, the NIH declines to provide exact wording for consent forms, and instead endorses a robust informed consent process where all necessary details are explained and understood in an ongoing, trusting relationship between the clinic and the donor(s).

Respondents asked for clarification regarding the people who must give informed consent for the donation of embryos for research. Some commenters suggested that NIH should require consent from the gamete donors, in cases where those individuals may be different than the individuals seeking reproductive treatment. The NIH requests consent from the individual(s) who sought reproductive treatment because this/these individual(s) is/are responsible for the creation of the embryo(s) and, therefore, its/their disposition. With regard to gamete donation, the risks are associated with privacy and, as such, are governed by requirements of the Common Rule, where applicable.

Respondents also requested clarification on the statement in the draft Guidelines noting that "although human embryonic stem cells are derived from embryos, such stem cells are not themselves human embryos." For the purpose of NIH funding, an embryo is defined by Section 509, Omnibus Appropriations Act, 2009, Pub. L. 111-8, 3/11/09, otherwise known as the Dickey Amendment, as any organism not protected as a human subject under 45 C.F.R. Part 46 that is derived by fertilization, parthenogenesis, cloning or any other means from one or more human gametes or human diploid cells. Since 1999, the Department of Health and Human Services (HHS) has consistently interpreted this provision as not applicable to research using hESCs, because hESCs are not embryos as defined by Section 509. This long-standing interpretation has been left unchanged by Congress, which has annually reenacted the Dickey Amendment with full knowledge that HHS has been funding hESC research since 2001. These guidelines therefore recognize the distinction, accepted by Congress, between the derivation of stem cells from an embryo that results in the embryos destruction, for which federal funding is prohibited, and research involving hESCs that does not involve an embryo nor result in an embryos destruction, for which federal funding is permitted.

Some respondents wanted to ensure that potential donor(s) are either required to put their "extra" embryos up for adoption before donating them for research, or are at least offered this option. The Guidelines require that all the options available in the health care facility where treatment was sought pertaining to the use of embryos no longer needed for reproductive purposes were explained to the potential donor(s). Since not all IVF clinics offer the same services, the healthcare facility is only required to explain the options available to the donor(s) at that particular facility.

Commenters asked that donor(s) be made aware of the point at which their donation decision becomes irrevocable. This is necessary because if the embryo is de-identified, it may be impossible to stop its use beyond a certain point. The NIH agrees with these comments and revised the Guidelines to require that donor(s) should have been informed that they retained the right to withdraw consent for the donation of the embryo until the embryos were actually used to derive embryonic stem cells or until information which could link the identity of the donor(s) with the embryo was no longer retained, if applicable.

Medical Benefits of Donation

Regarding medical benefit, respondents were concerned that the language of the Guidelines should not somehow eliminate a donor's chances of benefitting from results of stem cell research. Respondents noted that although hESCs are not currently being used clinically, it is possible that in the future such cells might be used for the medical benefit of the person donating them. The Guidelines are meant to preclude individuals from donating embryos strictly for use in treating themselves only or from donating but identifying individuals or groups they do or do not want to potentially benefit from medical intervention using their donated cells. While treatment with hESCs is one of the goals of this research, in practice, years of experimental work must still be done before such treatment might become routinely available. The Guidelines are designed to make it clear that immediate medical benefit from a donation is highly unlikely at this time. Importantly, it is critical to note that the Guidelines in no way disqualify a donor from benefitting from the medical outcomes of stem cell research and treatments that may be developed in the future.

Monitoring and Enforcement Actions

Respondents have expressed concern about the monitoring of funded research and the invocation of possible penalties for researchers who do not follow the Guidelines. A grantee's failure to comply with the terms and conditions of award, including confirmed instances of research misconduct, may cause the NIH to take one or more enforcement actions, depending on the severity and duration of the non-compliance. For example, the following actions may be taken by the NIH when there is a failure to comply with the terms and conditions of any award: (1) Under 45 CFR 74.14, the NIH can impose special conditions on an award, including but not limited to increased oversight/monitoring/reporting requirements for an institution, project, or investigator; and (2) under 45 CFR 74.62 the NIH may impose enforcement actions, including but not limited to withholding funds pending correction of the problem, disallowing all or part of the costs of the activity that was not in compliance, withholding further awards for the project, or suspending or terminating all or part of the funding for the project. Individuals and institutions may be debarred from eligibility for all Federal financial assistance and contracts under 2 CFR Part 376 and 48 CFR Subpart 9.4, respectively. The NIH will undertake all enforcement actions in accordance with applicable statutes, regulations, and policies.

These Guidelines apply to the expenditure of National Institutes of Health (NIH) funds for research using human embryonic stem cells (hESCs) and certain uses of induced pluripotent stem cells (See Section IV). The Guidelines implement Executive Order 13505.

Long-standing HHS regulations for Protection of Human Subjects, 45 C.F.R. 46, Subpart A establish safeguards for individuals who are the sources of many human tissues used in research, including non-embryonic human adult stem cells and human induced pluripotent stem cells. When research involving human adult stem cells or induced pluripotent stem cells constitutes human subject research, Institutional Review Board review may be required and informed consent may need to be obtained per the requirements detailed in 45 C.F.R. 46, Subpart A. Applicants should consult http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html .

It is also important to note that the HHS regulation, Protection of Human Subjects, 45 C.F.R. Part 46, Subpart A, may apply to certain research using hESCs. This regulation applies, among other things, to research involving individually identifiable private information about a living individual, 45 C.F.R. 46.102(f). The HHS Office for Human Research Protections (OHRP) considers biological material, such as cells derived from human embryos, to be individually identifiable when they can be linked to specific living individuals by the investigators either directly or indirectly through coding systems. Thus, in certain circumstances, IRB review may be required, in addition to compliance with these Guidelines. Applicant institutions are urged to consult OHRP guidances at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html

To ensure that the greatest number of responsibly derived hESCs are eligible for research using NIH funding, these Guidelines are divided into several sections, which apply specifically to embryos donated in the U.S. and foreign countries, both before and on or after the effective date of these Guidelines. Section II (A) and (B) describe the conditions and review processes for determining hESC eligibility for NIH funds. Further information on these review processes may be found at http://www.NIH.gov . Sections IV and V describe research that is not eligible for NIH funding.

These guidelines are based on the following principles:

As directed by Executive Order 13505, the NIH shall review and update these Guidelines periodically, as appropriate.

For the purpose of these Guidelines, "human embryonic stem cells (hESCs)" are cells that are derived from the inner cell mass of blastocyst stage human embryos, are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. Although hESCs are derived from embryos, such stem cells are not themselves human embryos. All of the processes and procedures for review of the eligibility of hESCs will be centralized at the NIH as follows:

The materials submitted must demonstrate that the hESCs were derived from human embryos: 1) that were created using in vitro fertilization for reproductive purposes and were no longer needed for this purpose; and 2) that were donated by donor(s) who gave voluntary written consent for the human embryos to be used for research purposes.

The Working Group will review submitted materials, e.g., consent forms, written policies or other documentation, taking into account the principles articulated in Section II (A), 45 C.F.R. Part 46, Subpart A, and the following additional points to consider. That is, during the informed consent process, including written or oral communications, whether the donor(s) were: (1) informed of other available options pertaining to the use of the embryos; (2) offered any inducements for the donation of the embryos; and (3) informed about what would happen to the embryos after the donation for research.

Prior to the use of NIH funds, funding recipients should provide assurances, when endorsing applications and progress reports submitted to NIH for projects using hESCs, that the hESCs are listed on the NIH registry.

This section governs research using hESCs and human induced pluripotent stem cells, i.e., human cells that are capable of dividing without differentiating for a prolonged period in culture, and are known to develop into cells and tissues of the three primary germ layers. Although the cells may come from eligible sources, the following uses of these cells are nevertheless ineligible for NIH funding, as follows:

Raynard S Kington, M.D., Ph.D.Acting Director, NIH

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NIH Guidelines for Human Stem Cell Research

Submitted by Bsra Elkatmis to fulfill the ethics in science requirement for theYoung Scientist Programat BMSIS.

Cells are the smallest known building blocks of living organisms. All of the cells in the human body have different functions. For example, white blood cells fight infection in the body while red blood cells carry oxygen, and heart muscle cells make the heart beat while neurons are used to transmit signals through the body and for the functions of the brain. On the other hand, stem cells are special cells with self-renewal and differentiation functions. Thanks to self-renewal property, stem cells can divide and produce more stem cells [1].

They are known as undifferentiated cells, which means that they can convert into specialized cell types. Stem cells can be classified according to how much they can differentiate into new cell types. The four main classifications are: totipotent, pluripotent, multipotent, and unipotent. Totipotent stem cells can turn into any other cell type. For example, the zygote, which is a fertilized egg cell, and the cells of the embryo up to the eight-cell stage are totipotent cells. These cells can form a complete and normal individual in the womb.

Pluripotent stem cells have the potential to differentiate into almost all cell types. For example, embryonic stem cells are formed from the inner cell mass of the blastocyst, which is a later stage of embryonic development.

Multipotent stem cells can differentiate into small groups of cells. For example, somatic stem cells are multipotent. This means that their differentiation potential is limited to a number of related cell types. Also, mesenchymal stem cells can be an example of multipotent stem cells. They have the potential to differentiate into cartilage cells, bone cells, and muscle cells [2]. The neural stem cells originate from the central nervous system. They can differentiate into nerve cells. The hematopoietic stem cells are another type of multipotent stem cell. They can differentiate into white blood cells and red blood cells.

Lastly, unipotent stem cells can only produce one type of cell. Even though they have a quite limited differentiation capacity, theyre still stem cells because of their self-renewal property. In this concept, they can maintain the undifferentiated stem cell pool as a result of this property.

Beyond these four main classifications, newly discovered induced pluripotent stem cells (also called iPS cells), are somatic cells that have reverted back to pluripotent stem cells under laboratory conditions.

Stem cell research is an open area to scientific development and has the power to treat people with destructive diseases such as Parkinsons, spinal cord injury, and more. For example, stem cell transplantation can be a good treatment for nervous system injuries, because they can maintain the function of damaged cells or tissues [3]. Despite this, there have been ethical questions raised as to the nature of stem cell research. One major question arises because of the methods used to obtain embryonic stem cells that in turn destroy the embryo.

Some people support that although the embryo is still under development, it is considered a potential person. The major problem with this is that the personhood criteria cannot be fully defined. It is claimed that the embryo should have respect and dignity since it would be human even if it did not have human characteristics yet. Others support that the fertilized egg is only an organic material just like our body parts until it can survive independently. If we destroy the blastocyst before it is attached to the womb, it cannot be mentioned of any harm or destruction, as it has no faith, desire, expectation, and purpose. Although both sides of the debate are interested in protecting human life, the position of the human blastula causes ethical problems [4].

Embryonic stem cells are obtained from cells within the blastula, one of the early stages of human formation. Just before the fertilized egg is implanted into the wall of the womb, it turns into a blastula that can survive for a short time. Blastula are harvested, isolated, and cultivated in a laboratory to use in stem cell research. They may even believe that when the egg is fertilized by sperm naturally or in vitro, personhood begins for blastocysts. Therefore, a moral dilemma arises in embryonic stem cell research.

The deontological approach is symbolized by Immanuel Kants principle of the Categorical Imperative, which underlined that persons must be treated as ends rather than as means. Individuals, as expressed in the Declaration of Independence, have been endowed by their Creator with certain unalienable rights, that among these are life, liberty and the pursuit of happiness. This argues that a persons life cannot be sacrificed to achieve better things. Some people who assume both a deontological approach and the position that human life begins at conception may then argue that blastocysts are persons who have rights [5]. According to such a position, the destruction of the blastocyst to obtain stem cells is unethical.

During in vitro fertilization, many spare embryos are created that will not be implanted within the womb. These spare embryos may then be used in stem cell studies. This may also be incompatible with Kants Categorical Imperative ethical perspective for someone who believes that human life begins at conception since the destruction of these spare embryos to obtain stem cells means sacrificing human life. Proponents of this position may argue that spare embryos are still persons. Another important point here is stem cell lines. The use of stem cell lines that were created by destroying blastocysts is morally wrong from the Categorical Imperative standpoint because it represents the act of destroying human life.

However, some who argue from a deontological perspective while also supporting the concept that human life begins at conception may actually consider it ethical to use stem cell lines in research because they suggest that stem cell lines were created in the past and we cant change that now. However, those arguing from that position may still be against creating new stem cell lines.

What about those with the deontological perspective, but who do not consider human life to begin at conception (and thus the blastocyst to not be a person)? In such a case, even though they accept the Categorical Imperative, they may see there being no personhood rights for blastocysts, and so no issue with recovery of stem cells at that stage. Meanwhile, for those who take such a stance, they may hold positions that human life begins at a variety of later stages of development (such as the development of the primitive streak or even at birth).

In either case (human life beginning at conception or at a time later in development), some will still take that position that even if it can be argued that blastocysts are not yet human, they are still part of human life, and thus they may still find that destroying blastocysts for stem cell research is unethical. For instance, U.S. President George Bushs Council on Bioethics in 2001 reminds one of such positions and of Kants Categorical Imperative as it stated that it is morally wrong to exploit and destroy developing human life, even for good reason [6].

Virtue ethics is an approach that tells us what kind of people we should strive to be and how we can be such people. For example, using something known as the eudaimonia perspective can be useful for this topic. Eudaimonia can be described as achieving self-realization and happiness. People struggle to improve their character and prevent suffering on the way to eudaimonia.

Applying eudaimonia to stem cell research may go something like this:

Stem cell research offers a curative way to treat destructive diseases such as spinal cord injury, Parkinsons, Alzheimers, and more.Having these disease conditions does not match the ideal of eudaimonia, as achieving this state is not possible with the pain and burden of these diseases.As we are trying to improve our character, we must eliminate situations that prevent eudaimonia.If the treatment of these diseases will be improved through stem cell research, then virtue ethics may find this research ethical from the point of view of eudaimonia and achieving a virtuous state.

Conversely, some virtue ethicists find it unethical to terminate embryo life for stem cell research. The argument they support for this can be described as a duty to respect the value of human life. Based on this concept, they consider that not harming human life is a virtuous human behavior. And they believe that people should strive accordingly.

The basis of utilitarianism is the greatest happiness. The fraction of the population suffering from diseases such as Alzheimers, Parkinsons, and diabetes increases every year. It can be argued that these diseases cause pain, discomfort, suffering, and burdens for those who have the disease as well as for their families and communities. Thus, for a utilitarian approach, it may be worth sacrificing embryos to save these peoples lives and reduce the prevalence of disease through conducting further stem cell research.

In the big picture, utilitarianism focuses on the maximum benefit that all of humanity will achieve through some action. The important thing here is to save as much life as possible, and it is very important to have lives that can be saved. When we look at stem cell research from this point of view, there is no problem in using embryos. Stem cell research provides for the greatest happiness by saving lives while reducing overall suffering.

After examining the purpose of stem cell research, it can be stated that it has a morally right consequence from a utilitarian approach. Stem cell treatment contributes to saving many peoples lives, prolonging human life, reducing health care costs, and more. Since the research and treatments carried out will serve the benefit of many people, they are supported by the utilitarian perspective.

Stem cell research has been a controversial topic for some time. When this topic is analyzed by different ethical approaches, all of them reveal different ethical results, and may even be used to argue both for and against this type of research. It is important to understand the ethical implications of stem cell research to respect the benefit and fundamental humanity of all interested sides. Although stem cell research has provided improvements for the quality of life of some, these actions can still be questioned morally. In addition, stem cell research continues to be an ethical dilemma within both political and religious ideologies. For example, each country has different legal regulations on stem cell research based often on their own internal dialogue on what is right. While reaching a common understanding about when personhood begins may cause this issue to be more tractable within an ethical framework, it is likely that questions will still persist as to the moral right to conduct embryonic stem cell research.

Bsra Elkatmis is an undergraduate student studying molecular biology and genetics at Gebze Technical University and a Research Associate in the BMSIS Young Scientist Program. Shes interested in plant science and the origin of life and enjoys growing plants in her spare time.

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Ethics of Stem Cell Research - Blue Marble Space Institute of Science

The Stem Cell Therapy Market research report forecast 2022 -2029 provides in-depth information on market trends, market capacity, industry size, growth factors, share, innovations, competitive environment, business problems, and more. This reports historical data confirms demand growth on a global, national, and regional scale. The research of the Stem Cell Therapy also aids in the understanding of industry prospects and growth chances. This report leverages advanced tools such as SWOT analysis and Porters Five Forces analysis to accurately estimate market and revenue growth. The report also provides an extensive analysis of the impact of the COVID-19 pandemic and how it contributed to market progress.

Market research reports from WMR include a competitive landscape, in-depth vendor selection methodology, and analysis based on qualitative and quantitative research to properly Stem Cell Therapy Market growth. In this Research Report, by analyzing key aspects such as profit, pricing, competition, and promotions, as well as examining, synthesizing, and summarising data from many sources, the analyst produces a comprehensive picture of the Stem Cell Therapy market. It shows a variety of market elements by identifying the top industry influencers. The market study further also draws attention to crucial industry factors such as global clients, potential customers, and sellers, which instigates positive company growth. In order to gauge the turning point of the businesses, significant market key players are also enlisted in order to deliver readers an in-depth analysis of industry strategies.

Osiris Therapeutics Molmed JCR Pharmaceutical NuVasive Anterogen Chiesi Pharmaceuticals Medi-post Pharmicell Takeda (TiGenix)

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Global markets are presented by Stem Cell Therapy type, along with growthforecasts. Estimates of production and valueare based on the price in the supply chain at which the Stem Cell Therapy are procured by the manufacturers.

This report has studied every segment and provided the market size using historical data. They have also talked about the growth opportunities that the segment may pose in the future. This study bestows production and revenue data by type, and during the historical period and forecast period.

Autologous Allogeneic

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This report has provided themarket size (production and revenue data) by application, during the historical period and forecast period.

This report also outlines the market trends of each segment and consumer behaviors impacting the Stem Cell Therapy market and what implications these may have on the industrys future. This report can help to understand the relevant market and consumer trends that are driving the Stem Cell Therapy market.

Musculoskeletal Disorder Wounds & Injuries Cornea Cardiovascular Diseases Others

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The Stem Cell Therapy Market engineering process uses a top-down and bottom-up approach and several data triangulation methods to evaluate and validate the size of the entire market and other dependent sub-markets listed in this research report. The major players in the market were identified through the second survey and the market rankings were determined through the first and second surveys.

To analyze actual Stem Cell Therapy market sales and their breakdowns, primary and secondary approaches were used. The Stem Cell Therapy assessment comprised extensive primary searches, such as surveys, expert opinions, profiles, and secondary ratings to business magazines, industry directories, paid venues, and others. In addition, the industry research examines data acquired from a range of sector analysts and significant market participants along the industrys value chain to provide a succinct quantitative and qualitative analysis.

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North America (U.S., Canada, Mexico) Europe (U.K., Italy, Germany, France, Rest of the EU) Asia-Pacific (India, Japan, China, South Korea, Australia, Rest of APAC) Latin America (Chile, Brazil, Argentina, Rest of Latin America) Africa and the Middle East (Saudi Arabia, U.A.E., South Africa, Rest of MEA)

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This research contains detailed information on the factors that are projected to impact Stem Cell Therapy market growth and share in the future.

The report examines the present situation of the Stem Cell Therapy market as well as future prospects for a variety of geographic locations.

It can be used as a SWOT and competitive landscape study when combined with Porters Five Forces analysis.

It gives an in-depth examination of the industry, highlighting its growth rates and expansion potential.

The research contains a wealth of information, including Stem Cell Therapy market dynamics and opportunities for the forecast period.

Quantitative, qualitative, value (USD Million), and volume (Units Million) data are among the segments and sub-segments.

Data on demand and supply forces, as well as their impact on the Stem Cell Therapy market, may be found at the regional, sub-regional, and country levels.

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Stem Cell Therapy Market (2022-2029) Size Will Escalate Rapidly in the Near Future: Osiris Therapeutics, Molmed - Digital Journal

DUBLIN--(BUSINESS WIRE)--The "Global Cell Therapy Market, By Use Type, By Therapy Type, By Product, By Technology & By Region- Forecast and Analysis 2022-2028" report has been added to ResearchAndMarkets.com's offering.

The Global Cell Therapy Market was valued at USD 14.86 Billion in 2021, and it is expected to reach a value of USD 35.95 Billion by 2028, at a CAGR of 13.45% over the forecast period (2022 - 2028).

Companies Mentioned

The cell therapy industry is being propelled forward by an increase in the number of clinical trials for cell-based treatments. As a result, global investment in research and clinical translation has increased significantly. The increasing number of ongoing clinical studies can be attributed to the presence of government and commercial funding bodies that are constantly providing funds to assist projects at various stages of clinical trials.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Cell Therapy Market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research and their market shares in the respective regions were determined through primary and secondary research.

This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives.

All percentage shares split, and breakdowns were determined by using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Segments covered in this report

The global cell therapy market is segmented based on Use-type, Therapy Type, Product, Technology, Application, and Region. Based on Use-type it is categorized into Clinical-use, and Research-use. Based on Therapy Type it is categorized into Allogenic Therapies, Autologous Therapies.

Based on Product it is categorized into Consumables, Equipment, Systems, and Software. Based on Technology it is categorized into Viral Vector Technology, Genome Editing Technology, Somatic Cell Technology, Cell Immortalization Technology, Cell Plasticity Technology, and Three-Dimensional Technology. Based on the region it is categorized into North America, Europe, Asia-Pacific, South America, and MEA.

Drivers

The increased demand for novel, better medicines for diseases such as cancer and CVD has resulted in an increase in general research efforts as well as funding for cell-based research. In November 2019, the Australian government released The Stem Cell Therapies Mission, a 10-year strategy for stem cell research in Australia.

The project would receive a USD 102 million (AU$150 million) grant from the Medical Research Future Fund (MRFF) to encourage stem cell research in order to develop novel medicines. Similarly, the UK's innovation agency, Innovate the UK, awarded USD 269,670 (GBP 267,000) in funding in September 2019 to Atelerix's gel stabilization technologies, with the first goal of extending the shelf-life of Rexgenero's cell-based therapies for storage and transport at room temperature.

Restraints

Despite technological advancements and product development over the last decade, the industry has been hampered by a lack of skilled personnel to operate complex devices like flow cytometers and multi-mode readers. Flow cytometers and spectrophotometers, which are both technologically advanced and extremely complex, generate a wide range of data outputs that require skill to analyze and review.

There is a global demand-supply mismatch for competent individuals, according to the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS). Over the next decade, the UK and Europe are expected to face a severe shortage of lab capabilities, with medical laboratories being particularly hard hit.

Market Trends

The expansion of the cell therapy market was aided by the growing frequency of chronic illnesses. Chronic illness is defined as a condition that lasts one year or more and requires medical treatment, affects everyday activities, or both, according to the US Centers for Disease Control and Prevention (CDC).

It includes heart disease, cancer, diabetes, and Parkinson's disease. Patients with spinal cord injuries, type 1 diabetes, Parkinson's disease (PD), heart disease, cancer, and osteoarthritis may benefit from stem cells.

For more information about this report visit https://www.researchandmarkets.com/r/aqmxta

More:
Global Cell Therapy Market Report (2022 to 2028) - Featuring Thermo Fisher Scientific, MaxCyte, Danaher and Avantor Among Others -...

When I was young,,,

36 reasons to VOTE YES! For Your Scientist Friends

By Don C. Reed

Author, STEM CELL BATTLES, other books

http://www.stemcellbattles.com

Dear Friend of Regenerative Medicine:

For the next month, I will make available a daily summary of one aspect of stem cell researchmy laymans understanding of itdone by scientists connected to the California Institute for Regenerative Medicine (CIRM). Todays is spina bifida, tomorrow is stroke.

Mistakes are mine.

In most cases I have left out the scientists names. A few I have written about in my books, and those I felt free to credit.

All I ask is that when you step into the voting booth, please consider which political party is likely to fund such research, and vote accordingly.

Spina Bifida: total awards (3) Award value: $16,798,263

The condition is devastating, and lasts a lifetime. The baby has a part of its spine bulging out of its lower back. Accompanying symptoms are many, including: headaches, vomiting, weakness in the legs, bladder and bowel problems.

Current standard of care (in utero surgery) leaves 58% of patients unable to walk independently.

39% of affected population are Hispanic or Latino descent.

The condition may cost several million dollars per patient, over his or her lifetime.

Spina Bifida (SB) appears to be caused by a combination of genetic and environmental conditions, but no one is sure. How will CIRM fight such a thing?

One way is Placenta-derived mesenchymal stem cells, seeded on a Cook Biodesign extracellular Matrix. Think of a mesh screen, over the wound.

THERAPEUTIC MECHANISM: Mesenchymal stem cellssecrete growth factors (and) cytokinesprotecting motor neurons from cell deathtreatment increases the density of motor neurons in the spinal cord, leading to improved motor functionultimately reducing lower limb paralysis. (1)

Grant recipient Diana Farmer began science as a marine biologist, who doing research at the famous Woods Hole Institute. On the way to receive an award, she suffered a car accident, and changed her mind, working on human biology. She was the first woman to perform surgery on a baby in its mothers womb. (1)

She and Aijun Wang received a CIRM grant to co-launch the worlds first human clinical trial using stem cells to treat spina bifida.. (2)

1. https://en.wikipedia.org/wiki/Diana_L._Farmer

2. https://health.ucdavis.edu/health-news/newsroom/state-stem-cell-agency-funds-clinical-trial-for-spina-bifida-treatment/2020/11

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Fighting One Disease or Condition per Day - Daily Kos

Not all stem cell transplants in individuals living with HIV and cancer, such as those used to cure Timothy Ray Brown and Adam Castillejo, among others, have been successful. Yet much can be learned about curing HIV from those whose lives could not be saved.

Research questionCurrently the only curative intervention for HIV is to transplant donor cells with a CCR5 delta32 genetic mutation in a person living with HIV (PLWH). But the impact of such transplants on HIV reservoirs in various organs has not been extensively characterized. A consortium of European researchers known as IciStem, established through amfAR funding, sought to gauge this impact by studying autopsy specimens from two individuals who underwent such transplants but were not cured and died soon afterwards.

FindingsThe first individual had been infected with HIV for 14 years and treated with antiretroviral therapy (ART) for that entire period. He was given a transplant in an attempt to cure a blood disorder known as MDS. On the 36th day following that procedure he achieved 100% chimerism. That meant that all his newly formed immune and other blood cells were the offspring of the donor and should be resistant to HIV infection. However, 29 days later that 100% value fell to 85%presumably related to an initially undetected population of recipient cells that were not destroyed by the transplant preparation procedure. He died of severe sepsis. At that time his blood still had no evidence of HIV, but all organs sampled, from brain to lymph node, showed signs of persistent infection.

The second individual had been infected with HIV for 22 years and treated with ART for the last 19 years. He required two transplants in an attempt to cure his acute leukemiathe first one having failed to take holdand on the 100th day following the first transplant (29 days after the second procedure) he achieved 100% chimerism. However, he died of lung failure eight days later. At that time no virus could be found in the blood, but the lymph node and spleen showed persistence of an HIV reservoir.

ImpactThe authors emphasize the need for examining tissues, not just blood, of PLWH having undergone potentially curative interventions as their results document that [t]issues play an essential role as a long-standing viral reservoir and routine [blood] sampling in living HIV-1-individuals will be insufficient to represent the extent of this reservoir.

amfARs roleamfAR was a funder of this research.

Original articlehttp://www.ncbi.nlm.nih.gov/pubmed/36146874

Dr. Laurence is amfARs senior scientific consultant.

See the article here:
The Issue of Tissue: Getting to the Source of the HIV Reservoir - amfAR, The Foundation for AIDS Research