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PubMedDate not supplied

Draft National Institutes of Health guidelines for research involving human pluripotent stem cells (December 1999).

The National Institutes of Health (NIH) is requesting public comment on a document entitled "Draft National Institutes of Health guidelines for research involving human pluripotent stem cells (December 1999)". The purpose of these draft guidelines is to recommend procedures to help ensure that NIH-funded research in this area is conducted in an ethical and legal manner. The NIH will not fund research using human pluripotent stem cells until final guidelines are published in the Federal Register and an oversight process is in place.

Beginning of Human Life↗
PubMed2002

New rules for embryo research: bill C-56 and the Canadian Institutes of Health Research stem cell research guidelines.

On 4 March 2002, the Canadian Institutes of Health Research (CIHR) released their guidelines for human pluripotent stem cell research. The guidelines set out the conditions for publicly funded stem cell research, and include limitations on acceptable sources of embryos for deriving stem cells. Two months later, the Government of Canada tabled Bill C-56, governing assisted human reproduction, which will also restrict the sources of embryos for research and require that all fertility clinics and embryo researchers be licensed. These two documents strike a middle ground between the current restrictive rules for publicly funded research in the United States and the more permissive rules for both publicly and privately funded research in the United Kingdom. Both documents restrict the source of embryos for research to those that were originally created for assisted reproduction purposes but are no longer required for such purposes. Therefore, under both the guidelines and Bill C-56 (if it becomes law), an efficient and cooperative relationship between fertility services providers and embryo researchers will be necessary if researchers in Canada are to continue to work with the human embryo in fields such as stem cell research.

Canada↗
PubMed2005

Eligibility of cryopreserved human embryos for stem cell research in Canada.

OBJECTIVE: To determine whether cryopreserved embryos in Canadian in vitro fertilization (IVF) clinics available (in theory) for research use are actually eligible (in practice) for stem cell research in accordance with the Assisted Human Reproduction Act, the Canadian Institutes of Health Research's Human Pluripotent Stem Cell Research: Guidelines for CIHR-Funded Research, and the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. METHODS: Copies of current and past patient information sheets and consent forms for embryo cryopreservation, the future disposition of cryopreserved embryos, and the donation of cryopreserved embryos for research were requested from Canadian IVF clinics. Fourteen of 24 clinics (response rate 58%) provided one or more of the requested documents. RESULTS: A review of the documents currently in use showed that, as of May 2005, all 14 responding clinics require an advance directive for the eventual disposition of cryopreserved embryos. Ten of these 14 clinics allow the donation of cryopreserved embryos for research. Only three of these 10 clinics, however, satisfy in writing the disclosure requirements for embryo research at the time of initial consent for the cryopreservation and future disposition of embryos. Only one clinic specifically identifies the option of embryonic stem cell research. CONCLUSION: Only three of the responding Canadian IVF clinics provide written details about future donation of cryopreserved embryos for research use and about the need for re-contact in accordance with relevant legislation and guidelines. Two of these three clinics, however, include disposition options that may not be legally available. In the event of death or loss of contact, it will not be possible to get project-specific research consent from the legitimate embryo providers as required by law. These same two clinics also fail to mention embryonic stem cell research as one of the research categories. It follows that we have identified only one Canadian IVF clinic with cryopreserved embryos unequivocally eligible for stem cell research, provided the forms we reviewed were used to obtain consent for the cryopreservation of those embryos.

Canada↗
PubMed2000

Reflections on the United States National Institutes of Health draft guidelines for research involving human pluripotent stem cells--theological perspective.

Since the human embryonic stem cell research involves destruction of human embryos and, therefore, hinges on the fundamental question of the status of the embryo, it is essential to examine this status carefully in order to establish fitting guidelines for research. The US National Institutes of Health has proposed its own guidelines on the matter recently (1999). The document, rooted in current pluralistic perspectives in moral philosophy (or bioethics), is criticised in this paper as morally inadequate. The argumentation of the criticism stems from the theological perspective on human personhood, which focuses on a continuity of personal identity from embryos to adult human beings. An additional concern for the author is the moral complicity in which the research dependent upon the destruction of human embryonic life is sanctioned.

Beginning of Human Life↗
PubMed2000

NIH guidelines. Researchers get green light for work on stem cells.

The National Institutes of Health (NIH) issued final guidelines last week allowing NIH-funded researchers to derive human pluripotent stem cells from fetal tissue, but not from embryos. Scientists may also work with embryonic stem cells, but may obtain them only from private sources and must ensure that derivation meets certain ethical conditions. The NIH spent nearly a year finalizing the guidelines, which researchers hope will allow work leading to the improved treatment of diabetes, Parkinson's, and other diseases.

Cell Line↗
PubMed2005

At the edge of humanity: human stem cells, chimeras, and moral status.

Experiments involving the transplantation of human stem cells and their derivatives into early fetal or embryonic nonhuman animals raise novel ethical issues due to their possible implications for enhancing the moral status of che chimeric individual. Although status-enhancing research is not necessarily objectionable from the perspective of the chimeric individual, there are grounds for objecting to it in the conditions in which it is likely to occur. Translating this ethical conclusion into a policy recommendation, however, is complicated by the fact that substantial empirical and ethical uncertainties remain about which transplants, if any, would significantly enhance the chimeric individual's moral status. Considerations of moral status justify either an early-termination policy on chimeric embryos, or, in the absence of such a policy, restrictions on the introduction of pluripotent human stem cells into early-stage developing animals, pending the resolution of those uncertainties.

Animal Experimentation↗
PubMed2005

Establishment and manipulation of monkey and human embryonic stem cell lines for biomedical research.

We have established several embryonic stem (ES) cell lines of the cynomolgus monkey. They maintain the normal karyotype and pluripotency in culture for long periods. We obtained government approval and grants to produce human ES cell lines from frozen surplus embryos in April 2002. We have established and characterized three human ES cell lines (KhES-1, KhES-2, KhES-3). We started distribution of human ES cells to other research groups in March 2004. It would be important to produce genetically modified monkey and human ES cells for various purposes. After improvement of the transfection and selection methods, we have produced monkey ES cells with integrated transgenes at efficient and reliable rates. We are also investigating reprogramming of somatic cells into pluripotent stem cells by cell fusion with ES cells. Such reprogramming could be used to produce pluripotent stem cells for each patient without therapeutic cloning, which would raise ethical concerns.

Animals↗
PubMed2006

Isolation and characterization of human embryonic stem cells.

The derivation of human embryonic stem (hES) cells is a challenging procedure. The isolation and maintenance of hES is visually and manually complicated, involving mechanical or enzymatic passaging using either collagenase or trypsin. This chapter describes detailed protocols that have been used for the derivation, maintenance, and characterization of hES cells in vitro along with protocols to test their differentiation potential in vivo. When used as a guideline, these protocols will assist researchers in setting up a hES cell laboratory.

Biomarkers↗
PubMed2000

A time for restraint.

The debate on the use of human embryos for research will be one of the more important issues of the 21st century. Unlike recombinant DNA technology, embryonic stem cell research most probably will result in the destruction of living embryos. Many people consider this research immoral, illegal, and unnecessary. Therefore, it is imperative to proceed cautiously. Federal funding of research using human embryos or pluripotent cells derived from them would be inappropriate until further resolution of the ethical issues has been achieved.

Bioethics↗
PubMed2006

Toward reprogramming cells to pluripotency.

The possibility of turning one somatic cell type into another may in the long run have beneficial applications in regenerative medicine. Somatic cell nuclear transfer (therapeutic cloning) may offer this possibility; however, ethical guidelines prevent application of this technology in many in countries. As a result, alternative approaches are being developed for altering cell fate. This communication discusses recent non-nuclear transfer-based in vitro approaches for reprogramming cells and enhancing their potential for differentiation toward various lineages.

Animals↗