DIVISION OF LEGISLATIVE SERVICES

VIRGINIAVIRGINIA

LEGISLATIVELEGISLATIVE

VOLUME 15, ISSUE 7 O C T O BER 2005

HJR 588: Medical, Dr. Friedman began by noting HIGHLIGHTS historical landmarks in transplantation, Ethical, and Scientific including the first successful kidney • Harvesting of bone Issues Relating to transplant performed in 1954 and the marrow by transplant expansion of nonembryonic stem cells to procurement teams, as Stem Cell Research include stem cells from umbilical cord Conducted in the well as the collection blood in the 1980s. He also noted that the and banking of cord Organ Procurement and Transplantation Commonwealth blood, would allow Network (OPTN) was established by stem cell therapy to be August 17, 2005 Congress under the National Organ Transplant Act (NOTA) of 1984; the available on a 24 hour United Network for Organ Sharing basis to the many The second meeting of the Joint (UNOS) of Richmond was founded in patients waiting for Subcommittee was held at the Fairfax 1984, and became the federal contractor transplantation. County Board of Supervisors Auditorium for the operation of the OPTN; and and featured an impressive panel of NOTA included language that led to the • Donor stem cells may experts. formation of the National Bone Marrow migrate and reproduce Donor Program. in any part of the body PRESENTATION BY The bone marrow program was of a patient receiving DR. GARY S. FRIEDMAN established to provide a data base of bone stem cell therapy; this marrow tissue types in order to provide Dr. Friedman is a physician with phenomenon has been more access to therapies using stem cells observed when broad transplantation experience, having for cancers and other disorders. UNOS, embryonic stem cells directed a transplant program for on the other hand, operates to provide 10 years and published extensively on solid organs on a need basis in an are transplanted, clinical transplantation, transplant egalitarian manner. Dr. Friedman noted but not with adult immunology, cellular pharmacology, and that physicians who perform transplants, stem cells. hematological issues in clinical transplan- solid organs or stem cells, are reimbursed tation. He is a founder of International for their services. He noted that federal Regenerative Medicine (a consortium law prohibits the sale of human tissue. focused on development of therapeutic Less than 20 percent of the people who applications of human stem cells), the are waiting for transplants actually Director of the Center for Regenerative undergo the procedure and time on the Medicine in Morristown, New Jersey, waiting list for solid organs has increased and a trustee of the New Jersey Stem Cell from one to two years to five to eight Research & Education Foundation. years in many regions. JOINT Dr. Friedman became interested in stem PRESENTATION BY SUBCOMMITTEE cell therapy, because he felt that the life DR. JOHN D. GEARHART STUDYING expectancies of patients waiting for organ MEDICAL, transplants could be extended with stem Dr. Gearhart, one of the preeminent ETHICAL, AND cell therapy and that organ supply and stem cell researchers in the United States, is SCIENTIFIC demand issues could be ameliorated. He the C. Michael Armstrong Professor, ISSUES also noted that many uses have been found Medicine of the Institute of Cell Engineer- RELATING TO for stem cells that can be provided through ing, Johns Hopkins University; professor of STEM CELL umbilical cord blood. He expressed gynecology and obstetrics and of physiol- RESEARCH concern that procurement programs for ogy at the Johns Hopkins University IN THE solid organs do not include the recovery of School of Medicine; and holds a joint COMMOWEALTH bone marrow (which contains stem cells appointment in the Department of Bio-

that can differentiate into blood, heart chemistry and Molecular Biology at the HIGHLIGHTS muscle, and other tissues) on a regular Bloomberg School of Public Health. He basis, because harvesting of bone marrow led the Johns Hopkins University research • The public wants stem is not reimbursed. Dr. Friedman supports team responsible for first deriving human cell therapies right the harvesting of bone marrow by trans- pluripotent stem cells in 1998. Much of his now; however, the plant procurement teams, as well as the research has been focused on how genes regulate the formation of tissues and development of stem collection and banking of cord blood. This would allow stem cell therapy to be embryos, particularly in examining mental cell research, as well as available on a 24 hour basis in order to retardation and other congenital birth potential therapies will respond to the growing patient therapy defects. take time. needs of the many Americans waiting for Dr. Gearhart began by responding to transplantation of stem cells or solid concerns about the formation of teratomas • Dr. Friedman organs. when embryonic stem cells are used in emphasized that the Dr. Friedman stated that using embryonic stem transplantation. He stated that he wanted to existing organizational cells requires massive culture of the cells and set the record straight, that "from the structure for organ and involves risk of tumor development, specifically experimental side when you isolate teratomas, or even malignancy. Donor cells may bone marrow collection derivatives, you don't put in a graphed migrate and reproduce in any part of the body of a embryonic stem cell. It will lead to a should be used for cord patient receiving stem cell therapy. This phenome- blood banking, non has been observed when tumor...." He noted that the experiments as well as for the embryonic stem cells are harvesting and banking transplanted, but not with adult stem cells. Because of STROMA (NICHE) THAT KEEPS STEM CELLS FROM DYING of donor bone marrow this, care must be taken to to provide plentiful avoid poor patient outcomes STEM CELL REPLENISHED STEM CELL sources of stem cells for and litigation. STEM CELL BEING use in regenerative Dr. Friedman empha- USED UP BY DIVISION medicine. sized that he believes the existing organizational ASYMMETRIC DIVISION OF • Internationally, there structure for organ and STEM CELL NEW bone marrow collection STEM are probably over 250 CELL should be used for cord validated embryonic blood banking, as well as stem cell lines, of which for the harvesting and 22 appear on the DIFFERENTIATING banking of donor bone CELLS President's list. marrow in order to

provide plentiful sources of stem cells for use in MAY DIFFERENTIATE INTO: regenerative medicine. OONERVE CELLS, OR OOMUSCLE CELLS, OR OOBLOOD CELLS, ETC. A.K. Szakal Stem Cell Asymmetric Differentiation must be performed correctly, making sure grafts Internationally, there are probably over JOINT do not contain embryonic stem cells, because 250 validated embryonic stem cell lines, of SUBCOMMITTEE the capacity of the stem cells to divide and which 22 appear on the President's list. STUDYING differentiate is a major safety issue. The Johns 's Stem Cell Institute MEDICAL, Hopkins program deals with various sources of has developed approximately 17 embry- ETHICAL, AND stem cells, including adult sources, umbilical onic stem cell lines. The number of stem SCIENTIFIC cord blood, embryonic stem cells, and stem cells being used in the United States is ISSUES cells derived from bone marrow. The research unknown, because private funds are being RELATING TO group seeks to address many stem cell biology used to derive stem cell lines that are not STEM CELL issues; however, most of the research is eligible for federal funding. Dr. Gearhart RESEARCH preclinical and experimental. Very little of the emphasized that studies of adult and IN THE research has resulted in clinical trials, which Dr. embryonic stem cells, thus far, in the Johns COMMONWEALTH Gearhart believes is appropriate. He observed Hopkins laboratory research model, that the public wants therapies right now; showed that embryonic stem cells work however, the development of medical applica- better . HIGHLIGHTS tions will take time. Speaking to somatic cell nuclear Dr. Gearhart focused on the uniqueness of transfer, Dr. Gearhart noted that scientists • The United States has the stem cell—embryonic or adult—and its agree that reproductive cloning of human lost the lead in stem capacity to self-renew (i.e., it can produce beings should not be allowed. The term cell research and another cell like itself and specialize into "therapeutic cloning" has been used since therapy development another cell type). Some stem cells can 1999, and scientists regret coinage of the to Australia, Singapore, divide only once and others can divide many term. The actual process would be to times, producing many different cell types match an embryonic stem cell line by Korea, Israel, and the [See illustration previous page]. This doing somatic cell nuclear transfer from the United Kingdom. intricate and difficult problem is the central patient to an oocyte and then generating a focus of stem cell science—trying to figure blastocyst. The resulting stem cell would • The National out which stem cells have the capacity for be a precise match for the patient, Academies only generating specific tissues. The only major eliminating host-graft rejection. address issues of clinical application of stem cells, at present, Dr. Gearhart concluded that studies of national significance, uses stem cells derived from bone marrow, human embryonic stem cells will result in mandated by Congress which contains two kinds of stem cells— important drug developments, but the or the executive hematopoietic and mesenchymal. Dr. stem cell controversy will continue. Only branch, or issues in Gearhart noted that regardless of the source, further study of both adult and embryonic which there is a certain criteria must be met in stem cell stem cells will reveal which stem cell perceived public need research: (i) self-renewal, (ii) stability, (iii) source works better. The United States as expressed through capacity to multiply and specialize, and (iv) has lost the lead in stem cell research and the scientific reproducible results for quality control. therapy development to Australia, The Johns Hopkins research group is Singapore, Korea, Israel, and the United communities. comparing various stem cell sources, which is Kingdom. Many of our country's bright- the only way to find out what works. He est students are looking for postdoctoral • Guidelines are explained that when you graft bone marrow, positions in these countries, because of essential because you are putting both types of stem cells the cutting-edge research and the there is public and (hemapoietic and mechenymal) into the availability of government and private scientific uncertainty individual, and the cells can migrate to any funding. about the appropriate organ in the body and may contribute to a procedures for variety of tissues. To illustrate, he posed the PRESENTATION BY conducting stem cell question: "Are the cells functional in the DR. JONATHAN D. MORENO research. tissues to which they contribute or are the cells simply residing in the tissue?" A neuron Dr. Moreno is the Emily Davie stem cell, for example, will only produce the and Joseph S. Kornfeld Professor of type of cell from the brain region from where Biomedical Ethics and the Director of the it is taken, but will not reproduce all other Center for Biomedical Ethics at the types of brain cells. University of Virginia; past president of the American Society for Bioethics and JOINT gametes, and stem cells derived from SUBCOMMITTEE Humanities; a bioethics advisor for the blastocysts produced using nuclear STUDYING Howard Hughes Medical Institute; and transfer. The guidelines address ethical MEDICAL, has published over 200 papers, numerous and legal concerns and encompass policy ETHICAL, AND reviews, and six books on subjects issues relating to the use of human SCIENTIFIC ranging from human experimentation to embryonic stem cells for research and ISSUES RELATING clinical studies and practice. Dr. Moreno therapy. Although the guidelines address TO STEM CELL was co-chair with Dr. Richard O. Hynes human embryonic stem cell research and RESEARCH of the National Academy of Science therapy, the recommendations could be IN THE Committee on Guidelines for Human applied to other human stem cell research, COMMONWEALTH Embryonic Stem Cell Research. including adult stem cells, fetal stem cells

Dr. Moreno's presentation was focused or embryonic germ cells. HIGHLIGHTS on the National Academies recently Among the issues addressed were issued human embryonic stem cell donor recruitment (informed consent, research guidelines, now published as a compensation, conflicts of interest, • The National book. He emphasized that the National confidentiality, risks of oocyte retrieval, Academies' position Academies are not government agencies, and use of genetic information); stem cell continues to be that although they are chartered by the federal characterization and standardization; human reproductive government and 90 percent of its work is safety in handling and storage of blasto- cloning should not be requested by Congress or the executive cysts and stem cells; sharing of materials branch. The embryonic stem cell guide- conducted. between laboratories; appropriateness of lines project was funded by two private and limitation on human embryonic stem foundations and National Academies' cell research and therapy; and safeguards • Compliance with the funds. The National Academies embry- against exploitation or misuse. National Academies' onic stem cell guidelines have no legal Having already recommended in 2002, guidelines are voluntary standing, only offer intellectual and that "[h]uman reproductive cloning should adoption of policies/ professional persuasion. The Academies not now be practiced. It is dangerous and practices that are only address issues of national signifi- likely to fail," the National Academies' consistent with the cance, mandated by Congress or the position continues to be that human recommendation and executive branch, or issues in which there reproductive cloning should not be the imposition of is a perceived public need as expressed conducted. The recommendations include: through the scientific communities. appropriate • Review by an Institutional Review Board, institutional sanctions Dr. Moreno cited the many reasons for informed consent of all donors, severing for noncompliance. developing embryonic stem cell guide- donation decisions from all clinical decisions, lines: prohibition of compensation or reimburse- ment to donors except for direct expenses, no commercialization (sale or purchase) of • Significant public support for human donated materials, and protection of donor embryonic stem cell research. privacy. • Diverse funding available for stem cell • Establishment of institutional oversight research—private, federal and state. committees and an independent national panel • Scientific concerns relating to the to evaluate and revise the adequacy of the hodgepodge of federal regulations. guidelines, as necessary. The institutional • Lack of regulation of privately supported oversight committees, referred to as human embryonic stem cell research. Embryonic Stem Cell Research Oversight (ESCRO) committees were recommended to • Public and scientific uncertainty about the include public and expert representation. appropriate procedures for conducting • Certain research with embryonic stem cells stem cell research. should not be permitted at this time, including in vitro culture of any intact human embryo The purpose of the guidelines is to beyond 14 days (a standard that has been encourage responsible stem cell practices, accepted by most scientists), any research in including the use of stem cells derived which human embryonic stem cells are introduced into nonhuman primate blastocysts from surplus blastocysts from in vitro or in which any embryonic stem cells are fertilization clinics, stem cells derived introduced into human blastocyts, and that from blastocysts derived from donated animals into which human embryonic stem cells have been introduced at any developmen- tal stage should not be allowed to breed. the rabbit's pellets ruined the cookies, JOINT The mechanisms for compliance with society's attempts to cover up or ignore a SUBCOMMITTEE the guidelines are voluntary adoption of little bad in something good is an effort to STUDYING policies/practices that are consistent with pretend that the "bad" does not really exist. MEDICAL, the recommendations and the imposition Father Pacholczyk posed the question, ETHICAL, AND of appropriate institutional sanctions for "What is wrong with a little bit of embryo SCIENTIFIC noncompliance. The guidelines have been destruction to help the greater good?" He ISSUES RELATING TO STEM CELL endorsed by the presiding or executive asserted that everyone in the room came from an embryo and acknowledged that RESEARCH officers of many prestigious institutions IN THE and organizations, and hopefully, other an embryo is a very small object. He insisted, however, that once everyone COMMONWEALTH states and entities will also consider adopting the guidelines. accepts the fact that they started out as an embryo, the focus is drawn to a discussion

of whether all human beings are created PRESENTATION BY HIGHLIGHTS equal, regardless of size. Thus, if all REV. TADEUSZ PACHOLCZYK human beings are created equal, the size Father Pacholczyk is the Director of of the human embryo doesn't matter; Education at the National Catholic Bioethics consequently, the destruction of human • Father Pacholczyk Center in Philadelphia, an ethicist, and a embryos to help other humans is wrong. emphasized that if all Catholic priest for the diocese of Fall River, Father Pacholczyk disputed the argument human beings are . Father Pacholczyk received made by those in favor of embryonic stem created equal, four undergraduate degrees in philosophy, cell research that there are hundreds of the size of the human biochemistry, molecular cell biology, and thousands of embryos in a deep freeze in embryo doesn't chemistry from the University of ; a vitro fertilization clinics that will be matter; consequently, in neuroscience, focusing primarily thrown away if not used. He stated that it the destruction of on cloning genes for neurotransmitter is important to realize that the "discarding human embryos to versus using for research" argument is a transporters that are expressed in the brain, help other humans is lever to pry open the door to what he feels from ; and studied for five wrong. years in Rome conducting advanced work in is the ultimate research goal--therapeutic theology and bioethics, examining the cloning. Father Pacholczyk emphasized • The critical issue is for question of delayed ensoulment of the human that discussion is very important and embryo. He is frequently asked to speak noted that, in his opinion, in vitro fertiliza- the country to lead in an regarding stem cells, cloning, and other tion "slipped under the radar screen." He ethical sense....and that biotechnologies, and has testified before the commented that the taking of a human we should take the high Massachusetts and Wisconsin State Legisla- embryo was "innocent life" compared ground not run tures and participated in a Pontifical confer- with society taking human life as a matter after the herd. ence on these subjects. of law through war and the death penalty. Father Pacholczyk's presentation focused Father Pacholczyk discussed alternatives • There are current and on the moral arguments and ethical consid- to embryonic stem cell destruction, such as potential problems with erations raised by stem cell research, the back-differentiating adult stem cells. embryonic stem cells, Dedifferentiation (reprogramming of a proper direction for issues addressed by the which are difficult to specialized cell or tissue to a simpler, legislatures in the future, and whether establish, handle, and medical efficiency should trump and triumph unspecialized form) of adult stem cells was maintain and carry the over ethics. He began with a short vignette postulated as a solution to the human about a mother teaching her young daughters embryonic stem cell controversy, because a possibility for causing a lesson after not allowing them to see a human embryo would not have to be tumors and tissue movie which contained a little bit of immoral- destroyed. The dedifferentiated adult stem destruction. ity. The girls' mother showed them how a cells could be differentiated forward in a little bit of bad can ruin a lot of good by new direction and have the potential to baking cookies with just a little of their pet become many different types of cells. rabbit's droppings in them. Dr. Pacholczyk Father Pacholczyk concluded by propos- applied the analogy to embryonic stem cell ing that the United States should not be research and warned that in the same way that concerned with being at the forefront of stem re-growth and reconnection in the JOINT cell research, but the critical issue is for the SUBCOMMITTEE country to lead in an ethical sense. He fears that spinal cord. STUDYING the raw power of science will lead to exploita- In describing the current uses of MEDICAL, tion, and that we should take the high ground, adult stem cells, Dr. Prentice enumer- ETHICAL, AND not run after the herd. ated treatments for cancers, autoim- SCIENTIFIC mune diseases, anemias, immunodefi- ISSUES PRESENTATION BY ciencies, bone/cartilage deformities, RELATING TO DR. DAVID A. PRENTICE corneal scarring, stroke, repairing STEM CELL cardiac tissues after heart attack, RESEARCH Dr. Prentice is a Senior Fellow for Life Parkinson's disease, growth of new IN THE Sciences at the Family Research Council in blood vessels, gastrointestinal epithelia, COMMOWEALTH Washington, D.C., and an Affiliated Scholar wound healing, and spinal cord injury.

for the Center for Clinical Bioethics at the Dr. Prentice concluded by highlight- HIGHLIGHTS Georgetown University Medical Center. Dr. ing the advantages of pursuing adult Prentice held positions at the Los Alamos stem cell research: adult stem cells are National Laboratory; the University of • Adult stem cells are the the most promising source for treat- Texas Medical School at Houston; and the ments; they multiply almost indefi- most promising source Indiana State University School of Medi- nitely, providing numbers sufficient for for treatments, because cine. Dr. Prentice is an internationally clinical treatments; they have proven they multiply almost recognized expert on stem cell research and successful in laboratory culture, in indefinitely; provide cloning and was selected by the President's animal models of disease and current numbers sufficient for Council of Bioethics to write a comprehen- clinical treatments; they have the clinical treatments; sive review of adult stem cell research for advantage to "home in" on damage; and have proven successful the Council's 2004 publication "Monitoring they avoid problems with tumor in laboratory culture; Stem Cell Research." formation, transplant rejection, and Dr. Prentice began his presentation by "home in" on damage; ethical quandary. discussing the current and potential prob- and avoid problems lems with embryonic stem cells, noting that NEXT MEETING with tumor formation, these stem cell lines are difficult to establish, transplant rejection, handle, and maintain and carry the possibil- The September 21 meeting of the and ethical quandary. ity for causing tumors and tissue destruction. joint subcommittee will focus on stem Dr. Prentice presented the members with cell research and related activities being evidence that some adult stem cells show conducted in Virginia. The materials pluripotent capacity. Scholarly articles have distributed at the August meeting may shown that adult stem cells from bone be accessed on the study's website and marrow can form new neurons in the human audiostreaming is also available. brain and that bone marrow stem cells can go on to form all body tissues. Studies have shown that placental amniotic stem cells potentially form any type tissue without producing tumors. Human cord blood stem cells, which are young stem cells, have been HJR 588: Joint Subcommittee shown to be pluripotent. Studying the Medical, Ethical, and Dr. Prentice continued by describing Scientific Issues Relating to Stem Cell studies from around the world in which adult Research Conducted in the stem cells have been demonstrated as being Commonwealth

effective in tissue repair. The first clinical The Hon. R. G. Marshall, Chairman

trials are under way to demonstrate that For information, contact: adult stem cells from brain, bone marrow, Norma Szakal, DLS Staff Attorney and umbilical cord blood provide therapeutic benefit after stroke. Clinical trials have been http://dls.state.va.us/stemcell.htm started in Australia and Portugal to deter- mine whether adult stem cells are capable of