StemCell Therapy

The Promise of Stem Cell Research

Human pluripotent stem cells are a unique scientific and medical resource. In 1998, scientists at the University of Wisconsin and at Johns Hopkins University isolated and successfully cultured human pluripotent stem cells. The pluripotent stem cells were derived using non-Federal funds from early-stage embryos donated voluntarily by couples undergoing fertility treatment in an in vitro fertilization (IVF) clinic or from non-living fetuses obtained from terminated first trimester pregnancies. Informed consent was obtained from the donors in both cases. Women voluntarily donating fetal tissue for research did so only after making the decision to terminate the pregnancy.

Because pluripotent stem cells give rise to almost all of the cells types of the body, such as muscle, nerve, heart, and blood, they hold great promise for both research and health care. This advance in human biology continues to generate enthusiasm among scientists, patients suffering from a broad range of diseases, including cancer, heart disease and diabetes, and their families. For example, further research using human pluripotent stem cells may help:

Questions have been raised about the usefulness of adult stem cells in research and treatment, especially as compared to pluripotent stem cells derived from embryos or fetal tissue. Indeed, there is enormous potential for research using such cells. Human adult stem cells have been isolated from tissues such as blood, brain, intestine, skin, and muscle. Furthermore, some adult stem cells have been shown to be more "plastic" than first thoughtthat is, some of these stem cells appear to be capable of developing into different kinds of cells than first predicted.

There is, however, considerable evidence that adult stem cells may have limited potential compared to pluripotent stem cells derived from embryos or fetal tissue. Human adult stem cells have not yet been isolated from all cell and tissue types, and they have not been shown to be capable of developing into all of the different cell and tissue types of the body. Furthermore, adult stem cells are difficult to obtain, since they are often present in only minute quantities. They are difficult to isolate and purify, and their numbers appear to decrease with age. Moreover, adult stem cells may have more DNA damage, and they appear to have a shorter life span than pluripotent stem cells. For all of these reasons, and because of the enormous potential of stem cell approaches to research and treatment, it is vitally important that scientists study and compare both pluripotent and adult stem cells.

The NIH is prohibited from using any appropriated funds for "... (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b))." Because of the enormous potential of human pluripotent stem cells to medical research, the NIH asked the General Counsel of the Department of Health and Human Services (DHHS) to determine whether research utilizing pluripotent stem cells is permissible under existing Federal law governing embryo and fetal tissue research. After careful consideration, the DHHS concluded that because human pluripotent cells are not embryos, current Federal law does not prohibit DHHS funds from being used for research utilizing these cells.

Recognizing the ethical and legal issues surrounding human pluripotent stem cell research and the need for stringent oversight of this class of researchoversight that goes beyond the traditional rigorous NIH scientific peer review processthe NIH issued a moratorium on the funding of this research until Guidelines could be developed and an oversight process could be implemented.

In April 1999, the NIH convened a working group of the Advisory Committee to the Director (ACD), NIH, to provide advice to the ACD relevant to guidelines and oversight for this research. The working group met in public session and included scientists, clinicians, ethicists, lawyers, patients, and patient advocates. During their deliberations, the group considered advice from the National Bioethics Commission, the public, and scientists. Draft guidelines for this research were published for public comment, and, after reviewing and considering all comments received, the NIH Guidelines for Research Using Human Pluripotent Stem Cells (NIH Guidelines) were published in the Federal Register and became effective on August 25, 2000. (Because the NIH Guidelines contained a few incorrect citations and other minor errors, a notice of correction (65 FR 69951) was published on November 21, 2000.) The revised NIH Guidelines and other information about stem cell research can be found at the URL: /news/pages/default.aspx.

The purpose of the NIH Guidelines is to set forth procedures to help ensure that NIH-funded research in this area is conducted in an ethical and legal manner. By issuing these Guidelines, the NIH aims to enhance both the scientific and ethical oversight of this important arena of research and the pace at which scientists can explore its many promises. These Guidelines will encourage openness, provide appropriate Federal oversight, help make certain that all researchers can make use of these critical research tools, and help assure full public access to the practical medical benefits of research using these cells.

The Guidelines prescribe the documentation and assurances that must accompany requests for NIH funding for research using human pluripotent stem cells derived from human embryos or fetal tissue. These include the following:

Read the original:
NIH Fact Sheet on Human Pluripotent Stem Cell Research ...

This entry was posted on June 28, 2015 at 11:44 pm and is filed under Legal Issues Stem Cells. You can follow any responses to this entry through the RSS 2.0 feed. Both comments and pings are currently closed. |