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The Working Group on the Criteria for Cell-Based Therapies
A Project of the Program in Cell Engineering, Ethics, and Public Policy (PCEEPP), Johns Hopkins University
Supported by a grant from the Greenwall Foundation
The potential of stem cells and related cell-based therapies to treat disease and injury in humans has generated great excitement in the scientific community as well as among patients and their advocates. At the same time, ethical and political debates about the use of human embryos in medical research have captured the public's attention. There is considerable disagreement about the importance of embryonic sources of stem cells to the advancement of cell science, and there is no agreement as to whether the anticipated benefits justify either the destruction of existing embryos or the creation of embryos for purposes of research.
This debate, however energetic, does not exhaust the moral questions that need to be considered in policymaking about stem cell research. It is essential to engage in serious discussions about the next generation of ethical and policy issues in stem cell research on an ongoing basis, while research advances, rather than to react to scientific developments after they occur.
As an interdisciplinary group comprised of leaders in the fields of stem cell biology, ethics, law, population genetics, and transplantation immunology, supplemented by a core group of scientists and scholars from PCEEPP, we considered the following question - does the transition in stem cell research from the laboratory to first human trials and, ultimately, to human therapies raise any particular ethical and policy issues that are either unique to the stem cell context or of heightened concern? We answered this question by focusing first on considerations of safety and secondly on considerations of justice.
The Working Group met for two plenary sessions, on Sept. 4, 2002, and Jan. 17, 2003. Through the plenary sessions and through a variety of smaller meetings, including one-on-one discussions, the Working Group has engaged in in-depth exploration of relevant topics such as immunologic rejection, human leukocyte antigen (HLA) matching in transplantation, conceptions of race and ethnicity, the feasibility of a stem cell "bank" for therapeutic and/or research use, patents and intellectual property, and justice and access to medical technology, among others. While there is literature on each of these topics, the Working Group is, to our knowledge, the first interdisciplinary, collaborative body to examine these issues in regards to stem cell research and cell-based therapies in the American context. The Working Group has authored two reports, one on safety issues in cell-based intervention trials and the other on justice considerations in stem cell research and therapy. The safety paper is published in the November issue of Fertility and Sterility, and the justice paper will appear in the November/December issue of The Hastings Center Report.
Dan W. Brock, Ph.D.
Professor Emeritus, Department of Philosophy, Brown University
Dan W. Brock is Professor Emeritus of Philosophy at Brown University, where he was also the Charles C. Tillinghast, Jr. University Professor, Professor of Philosophy and Biomedical Ethics, and Director of the Center for Biomedical Ethics through June, 2002. Dr. Brock has published numerous papers in bioethics and in moral and political philosophy. He is the author of Deciding For Others: The Ethics of Surrogate Decision Making, 1989 (with Allen E. Buchanan); Life and Death: Philosophical Essays in Biomedical Ethics, 1993; and From Chance to Choice: Genetics and Justice (with Allen Buchanan, Norman Daniels and Daniel Wikler), 2000.
Patricia A. King, J.D.
Carmack Waterhouse Professor of Law, Medicine, Ethics, and Public Policy, Georgetown University Law Center
Patricia A. King is the Carmack Waterhouse Professor of Law, Medicine, Ethics, and Public Policy at Georgetown University Law Center and an Adjunct Professor in the Department of Health Policy and Management, Johns Hopkins University Bloomberg School of Public Health. Professor King's expertise is in the study of law, medicine, ethics and public policy. She is co-author of Cases and Materials on Law, Science and Medicine, and is a member of the American Law Institute and the Institute of Medicine and a Fellow of the Hastings Center.
Stephen J. O'Brien, Ph.D.
Chief, Laboratory of Genetic Diversity, National Cancer Institute
Stephen J. O'Brien has been Chief of the Laboratory of Genomic Diversity (formerly Laboratory of Viral Carcinogenesis) at the National Cancer Institute, National Institutes of Health since 1986. Dr. O'Brien is internationally recognized for his research contributions in human and animal genetics, evolutionary biology, AIDS, retrovirology and species conservation. In collaboration with his students, fellows, and colleagues, his list of achievements include: gene mapping of over 100 human genes including scores of cancer oncogenes; development of the domestic cat gene map as a model for comparative genome analyses; discovery of the remarkable genetic uniformity of the African cheetah, a prelude to genetic assessment of endangered species; solving the century-old evolutionary riddle of the giant panda's evolutionary history; discovery of the epidemic prevalence of feline immunodeficiency (AIDS) virus among wild cat species; and description of the first human gene to affect HIV-1 infection and AIDS progression, CCR5. His group has now identified eight distinct human genetic variants that influence the outcome of exposure to HIV.
David H. Sachs, M.D.
Paul S. Russell/Warner-Lambert Professor of Surgery, Harvard University Medical School;
Director, Transplantation Biology Research Center, Massachusetts General Hospital
David H. Sachs is the Director of the Transplantation Biology Research Center at Massachusetts General Hospital and the first Paul S. Russell/Warner-Lambert Professor of Surgery (Immunology), Harvard University Medical School. Dr. Sachs' research achievements include: discovery of Ia (Class II) antigens in 1973; development of monoclonal anti-bodies to MHC antigens; development of a unique large animal model for transplantation using miniature swine; use of mixed marrow reconstitution as a means of inducing specific transplantation tolerance; and studies of specific transplantation tolerance to allografts and xenografts in murine, swine and primate models.
Davor Solter, M.D., Ph.D.
Director, Max Planck Institute of Immunobiology, Department of Developmental Biology
Davor Solter is the Director of the Max Planck Institute of Immunobiology. He is also an Adjunct Senior Staff Scientist at the Jackson Laboratory, Bar Harbor. He has been and continues to be a member of numerous editorial and advisory boards and is currently the European Editor of Genes & Development. He is a member of the American Academy of Arts and Sciences, EMBO, and Academia Europea. In 1998 he received the March of Dimes Prize in Developmental Biology for pioneering the genetic concept of imprinting. Davor Solter contributed significantly to many areas of mammalian developmental biology, namely: differentiation of germ layers; role of cell surface molecules in regulating early development; biology and genetics of teratocarcinoma; biology of embryonic stem cells; imprinting and cloning. His current research interest focuses on genetic and molecular control of genome reprogramming and of activation of the embryonic genome.
Sonia M. Suter, J.D.
Associate Professor of Law, George Washington University Law School
Sonia M. Suter joined the George Washington University Law School faculty in 1999 after holding a Greenwall Fellowship in Bioethics and Health Policy at Georgetown and Johns Hopkins Universities.
While in law school, she was Executive Articles Editor of the Michigan Law Review and was awarded the Henry M. Bates Memorial Scholarship, the highest law school award. Professor Suter clerked for Judge John M. Walker, Jr. of the U.S. Court of Appeals for the Second Circuit. Prior to attending law school, she earned a Master of Science and achieved Ph.D. candidacy in human genetics. She worked as a genetic counselor for two years. Professor Suter has taught torts, genetics and the law, and bioethics and the law at the University of Michigan Law School. Her scholarship focuses on legal issues in medicine and genetics, as well as bioethics.
Catherine M. Verfaillie, M.D.
Professor of Medicine in the Division of Hematology, Oncology, and Transplantation, University of Minnesota; Director, Stem Cell Institute, University of Minnesota
Catherine M. Verfaillie is a Professor of Medicine in the Division of Hematology, Oncology and Transplantation and Director of the Stem Cell Institute in Minneapolis, MN. She holds the Anderson Chair in Stem Cell Biology, the Tulloch Chair in Stem Cell Biology, Genetics and Genomics, and the McKnight's Presidential Chair in Stem Cell Biology. The major research interest of her lab is stem cell biology. This includes studies pertaining to the regulation of proliferation, differentiation, and lineage commitment of normal hematopoietic stem cells and hematopoietic stem cells from patients with chronic myelogenous leukemia by cytokines and components of the extracellular matrix and to the genetic characterization of hematopoietic stem cells and their progenitors. In addition, over the last four years her lab has studied the plasticity of stem cells, via purification, expansion, and characterization of differentiation of multipotential post-natal stem cells from marrow, brain and muscle to mesodermal, ectodermal and endodermal lineages; analysis of the molecular signals required for commitment to differentiated multipotent stem cell types by functional genomics; and evaluation of their therapeutic potential in congenital disorders (MPS, Gaucher's, hemophilia) or for the treatment of cartilage, muscular, vascular, myocardial diseases, neurodegenerative and ischemic disorders, and liver or pancreas disorders.
LeRoy B. Walters, Ph.D.
Joseph P. Kennedy Sr. Professor of Christian Ethics and Professor of Philosophy, Kennedy Institute of Ethics, Georgetown University
LeRoy B. Walters is the Joseph P. Kennedy, Sr. Professor of Christian Ethics at the Kennedy Institute and past Director of the Kennedy Institute of Ethics at Georgetown University. Much of Dr. Walters’ research has been devoted to ethical issues in human genetics. He has served for three terms on the Recombinant DNA Advisory Committee of the National Institutes of Health. Since 1975, Dr. Walters has been the editor and co-editor (with Joy Kahn) of the annual Bibliography of Bioethics (22 volumes to date). He is also co-editor (with Tom L. Beauchamp) of an anthology entitled Contemporary Issues in Bioethics (4th ed., Wadsworth, 1994). Dr. Walters co-authored The Ethics of Human Gene Therapy with Julie Gage Palmer (Oxford University Press, 1997).
Dawn Mueller Agnew, Ph.D., cPNP
Pediatric Nurse Practitioner, Sinai Hospital;
Postdoctoral Research Fellow, Department of Pathology, Johns Hopkins University
Dawn Mueller Agnew is a Pediatric Nurse Practitioner in the Pediatric Emergency Department at Sinai Hospital, Baltimore, Maryland. She received her undergraduate degree in Nursing from Indiana University of Pennsylvania and her Master of Science in Advanced Pediatric Nursing from the University of Maryland, Baltimore. Her doctorate was from the University of Maryland, Baltimore in Nursing and Neurophysiology. While at Johns Hopkins University School of Medicine, she completed her doctoral work in the laboratory of Anesthesia/ Critical Care Medicine and her postdoctoral research in the Developmental Genetics Laboratory/Department of Obstetrics and Gynecology. Dr. Agnew's current research focuses on the derivation of neural precursors from human embryonic stem cells and transplantation of these cells in the neonatal mouse pup following ischemic brain injury and paralysis.
Alison S. Bateman-House, M.A.
Research Program Coordinator, The Phoebe R. Berman Bioethics Institute
Alison S. Bateman-House is the Project Manager for the Working Group on the Criteria for Cell-Based Therapies, the first joint project for the Phoebe R. Berman Bioethics Institute and the Institute of Cell Engineering. She is also the Program Coordinator for the PCEEPP program. She holds an undergraduate degree in Anthropology and a Master of Arts in Bioethics from the University of Virginia. She joined the Berman Bioethics Institute in 2000 as an interviewer and data manager for a multi-site study concerning informed consent in early phase clinical trials.
Hilary Bok, Ph.D.
Henry R. Luce Professor of Bioethics and Moral and Political Theory;
Core Faculty, The Phoebe R. Berman Bioethics Institute and Department of Philosophy
Hilary Bok is an Associate Professor of Philosophy and the Luce Professor in Bioethics and Moral and Political Theory. She has been the recipient of a Laurance S. Rockefeller fellowship. She is the author of Freedom and Responsibility (1998) and several articles. Her areas of interest are ethics, bioethics, freedom of the will, and Kant.
Aravinda Chakravarti, Ph.D.
Henry J. Knott Professor and Director, McKusick-Nathans Institute of Genetic Medicine;
Professor of Medicine, Pediatrics, and Molecular Biology and Genetics
(Dr. Chakravarti is the only Hopkins member of the Working Group who is not also part of the Program in Cell Engineering, Ethics and Public Policy.)
Aravinda Chakravarti is the Director of the McKusick-Nathans Institute of Genetic Medicine at the Johns Hopkins University School of Medicine. Dr. Chakravarti is a past member of the NIH National Advisory Council of the National Human Genome Research Institute, and he chaired the NIH Subcommittee on the 3rd 5-year Genome Project Plan. His research is aimed at genomic-scale analysis of the human genome and understanding the molecular genetic basis of common genetic disorders using contemporary genomic tools. He is an expert on computational biology and a geneticist known for his studies of predisposing genetic factors in such common and complex human diseases as diabetes, heart disease, and mental illness.
Liza Dawson, Ph.D.
Faculty Associate, The Phoebe R. Berman Bioethics Institute
Liza Dawson is a Research Associate in the Department of Health Policy and Management at the Johns Hopkins University Bloomberg School of Public Health and a Faculty Associate in the Phoebe R. Berman Bioethics Institute. Her current interests include ethics and policy issues in public health and biomedical research, in both the international and domestic setting. Since 1998 she has worked at the Berman Bioethics Institute, participating in a study directed by Dr. Nancy Kass on informed consent in early phase clinical trials and serving as project director for a study of researcher attitudes and ethical issues in developing country health research. In 2000-2001 she was a consultant to the National Bioethics Advisory Commission (NBAC) and worked on their reports concerning ethical issues in international research and ethical oversight of human research.
Ruth R. Faden, Ph.D., M.P.H.
Philip Franklin Wagley Professor of Biomedical Ethics;
Executive Director, The Phoebe R. Berman Bioethics Institute
Ruth R. Faden is the Philip Franklin Wagley Professor of Biomedical Ethics and Executive Director of the Phoebe R. Berman Bioethics Institute at Johns Hopkins University. She is a Senior Research Scholar at the Kennedy Institute of Ethics, Georgetown University. Dr. Faden is the author and editor of numerous books and articles on biomedical ethics and health policy including A History and Theory of Informed Consent (with Tom L. Beauchamp); AIDS, Women and the Next Generation (Ruth Faden, Gail Geller and Madison Powers, eds.); and HIV, AIDS and Childbearing: Public Policy, Private Lives (Ruth Faden and Nancy Kass, eds.). She is a Co-director of PCEEPP, along with John D. Gearhart.
John D. Gearhart, Ph.D.
C. Michael Armstrong Professor of Medicine; Director, Division of Developmental Genetics
John D. Gearhart is the C. Michael Armstrong Professor of Medicine, Professor of Gynecology and Obstetrics, Physiology, and Comparative Medicine in the Johns Hopkins University School of Medicine, and Professor of Biochemistry and Molecular Biology in the Johns Hopkins University Bloomberg School of Public Health and Hygiene. He is a member of the Institute of Cell Engineering and the Institute of Genetic Medicine. He serves as Director of the Division of Developmental Genetics, Director of Research for Gynecology and Obstetrics, and Director of Preimplantation Genetic Diagnosis. He is a co-director of PCEEPP with Ruth Faden. Dr. Gearhart is a developmental geneticist with research programs in the genetic control of mammalian development and in human stem cell biology. In 1998 Dr. Gearhart published the landmark paper on the derivation of human pluripotent stem cells from primordial germ cells.
Mark Greene, Ph.D., M.Litt
Greenwall Fellow in Bioethics and Health Policy, Johns Hopkins and Georgetown Universities
Before beginning his study in philosophy, Dr. Greene worked as a veterinarian surgeon. His graduate work focused on metaphysics, philosophy of biology, and applied ethics, specializing at Stanford in the philosophy of language and metaphysics, while continuing his study of metaethics, applied ethics, as well as philosophy of biology. His writings have focused on ethical issues in germ-line genetic therapy and the relationship between genetics and human identity. Dr. Greene has taught in the Philosophy Department at Stanford University (1999 to 2002) and is currently a Fellow of the Johns Hopkins and Georgetown Universities' jointly administered Greenwall Fellowship Program in Bioethics and Health Policy.
Kathryn E. Schill, M.A.
Research Program Coordinator, The Phoebe R. Berman Bioethics Institute
Kathryn E. Schill is the Project Manager for the Working Group on Interspecific Chimeric Brains, the second joint project for the Phoebe R. Berman Bioethics Institute and the Institute of Cell Engineering. She majored in Bioethics as an undergraduate at Davidson College and went on to complete a Master of Arts in Bioethics at Case Western Reserve University. Her personal research interests center upon reproductive ethics and include theories of personhood and the morality of abortion.
Andrew Siegel, Ph.D., J.D.
Assistant Professor of Gynecology and Obstetrics, Johns Hopkins University School of Medicine;
Associate Director of Academic Programs, The Phoebe R. Berman Bioethics Institute
Andrew Siegel is an Assistant Professor of Gynecology and Obstetrics at the Johns Hopkins University School of Medicine and a Core Faculty member and Associate Director for Academic Programs at the Phoebe R. Berman Bioethics Institute. Dr. Siegel has served as Staff Philosopher for President Clinton's National Bioethics Advisory Commission, as Legislative Fellow for Senator Edward M. Kennedy, and as Staff Attorney for the Task Force on Genetic Testing of the Working Group on the Ethical, Legal, and Social Issues of the Human Genome Project.