NIH stem cell guidelines please scientists
The NIH guidelines in effect as of 7 July don’t specify exactly which human embryonic stem cell lines can be studied with federal funding, but researchers are still pleased. Not only will more lines be eligible for funding, now the NIH has said it will make the time-consuming call of whether embryos used to create lines were donated under fundable criteria (appropriate informed consent, creation for reproductive purposes, donated without financial inducements.) That’s a huge relief for ethics committees at individual universities that might otherwise do redundant, difficult work.
New lines must follow specific informed-consent criteria described in the 2009 guidelines. For existing lines, researchers may seek review from experts assembled by the NIH. I’m assuming that at least some decisions will be made by September, when NIH will award the new funds from the stimulus package.
For these decisions, the NIH will be paying attention to an analysis last year found that some of the lines eligible for funding under President Bush did not meet criteria for informed consent.
See Consent issues restrict stem-cell research (shorter, by subscription to Nature)
When the past catches up with the present(free from Nature Reports Stem Cells, detailed)
Scientists seem delighted. See coverage from Nature (will need a subscription after 15 July), the http://www.nytimes.com/2009/07/07/science/07stem.html?_r=1
, and a blog from Newsweek .
Also, an editorial from Nature.
Comments
Ethics in relation to use of iPS or EC stem cells for doctors
By
Authors_:
Professor Pranab kumar Bhattacharya,Professor of.pathology, IPGME&R Kolkata-20
Miss Upasana Bhattacharya Dr. Avisnata Das MBBS(cal)
The U.S. government will now be able to fund research that involves human embryonic stem cell lines derived since August 9, 2001,as president USA Mr BarraK Obama’s remarks. Pluri -potent stem cells includes*embryonic stem (ES) and germ (EG) cell lines and embryonic carcinoma (EC) cell lines **ES cells, isolated from human blastocyst and maintained in culture without differentiation for long periods.**EG cells are isolated from primordial germ cells of genital ridges of 5-9 weeks old fetuses and form embryoid bodies***. EC cells are isolated from tetarocarcinomas.
The use of induced pluripotent embryonic stem cells (iPS) for regenerative medicine has captured the public’s imagination and fuelled rising expectations of clinical benefits in very advanced countries. Clinicians in advanced countries today increasingly needs to manage his patients’ expectations of what exogenious stem cells may, or indeed may not, offer. Regenerative medicine is however a long way discipline. It can be summarized as treatments that seek to restore structure and function after injury and, by this definition, includes solid organ transplantation by exogenious stem cells from stem cell banks. Exogenious cultured Stem cells are also routinely today used in hematology( Peripheral blood stem cells/ cord blood stem cells/ allogenic bone marrow stem cells are used for hematological malignancies even in west Bengal, India), plastic surgery (cultured autologous keratinocytes for skin loss or burns), and in orthopedics (autologous chondrocyte transplantation for articular cartilage defects) or in CNS disorders like in Parkinson’s diseases, Multiple sclerosis, Motor neurone disease as Neurons can be generated from skin, skeletal muscle, hematopoietic stem cells (HSC), mesenchymal stem cell lines etc.. But surprisingly not for stroke which is a major burden of neurological mortality. The use of such human embryonic stem cells both for research and therapeutic purposes sparks an ethical debate in our mind, Induced pluripotent stem cells (iPS) are mature cells taken from adults, such as skin cells, and transformed in the laboratory into pluripotent cells that can mature into a variety of different cell types. Researchers have generated more than 10 disease-specific iPS cell lines derived from patients with a variety of genetic diseases, such as diabetes and Parkinson’s disease but not for stroke. Please note it that exogenous stem cell transplantation, is fraught with both technical ,ethical and huge but huge cost difficulties for resource poor counties. A more attractive option that authors think it will be much effective if one can however some how would mobilize endogenous progenitor cells instead of exogenous cultured stem cell therapy. Many colony stimulating factors such as erythropoietin (EPO) and granulocyte colony stimulating factor (G-CSF) are used to mobilize the hematopoitic stem cells as for example[2].
Because iPS cells are derived from adult tissue, they seemingly sidestep the ethical issues of working with human embryos. A 2005 report by the President’s Council on Bioethics called iPS cells “ethically unproblematic and acceptable for use in humans.” A recent paper argues that the potential uses of iPS cells might pose ethical issues to the donors. iPS cells could be used to identify and test new therapeutics at research level and might also themselves be used as part of cell replacement therapy. Because the technology is so new, there are many unknown applications, adverse reactions – which is fine, because it looks like iPS cells can be grown in the laboratory indefinitely. Hence the ethical issue: People who donate their cells for iPS research might not have intended that their cells be used in a particular application for treatment. We hope that U.S. regulations allow scientists to use biological materials for research without donor consent if the material is de-identified from the donor, which many of the pioneering iPS studies did. However, genome sequencing could allow donor’s cells to be re-identified. Moreover, donors might support use of their cells in research, but not in sensitive areas such as in reproduction biology or in transplantation or for medical buisness.
Reference
1. Siddharthan Chandran What are the prospects of stem cell therapy for neurology? BMJ 2008;337:a1934
2 .Sprigg, N, Bath PM, Zhao L, Willmot MR, Gray LJ, Walker MF, et al., Granulocyte-colony stimulating factor mobilises bone marrow stem cells in patients with sub-acute ischaemic stroke: the 'Stem cell Trial of recovery EnhanceMent after Stroke' (STEMS) pilot randomised controlled trial. Stroke 2006;37:2979-2983
3. Rapid responses publ;ished by by Nikola Sprigg, Tim England, Philip Bath “Stem cells for stroke (9 January 2009) for the article ANALYSIS: by authorSiddharthan Chandran What are the prospects of stem cell therapy for neurology? BMJ 2008; 337: a1934
Posted by: Professor Pranab kumar Bhattacharya etal | July 20, 2009 12:11 PM