Category Archives: South Dakota Stem Cells

In recent years, biomedical research has been significantly altered by technologies for the derivation of human cell lines capable of differentiation into any of the cells of the human body. Such cells are sometimes called "pluripotent" because they have the power ("potency") to become many ("pluri-") different cells. It has long been known that such cells exist, but it wasnt until 1981 that stem cells were isolated from mouse embryos (Evans and Kaufman, 1981; Martin, 1981), and only in 1998 that the derivation of human embryonic stem cells was first reported (Thomson et al., 1998). This tool was quickly recognized as an opportunity to better understand normal and pathological human development, to identify and test new pharmacological therapies, and perhaps to even replace diseased tissues or organs. Many scientists viewed this as a potentially revolutionary approach to studying human biology. However, because a necessary first step was to use and destroy human embryos such research raised serious questions for some members of the public, as well as some scientists.

While most hESC scientists view the human embryo as human cells with great biological and scientific potential, there are many members of our society who hold religious beliefs that define the human embryo as equivalent to a human life. By this view, any harm or destruction of the human embryo is tantamount to harm or destruction of a human life. This perspective has become more than a matter of personal opinion. For many years now, under the Dickey amendment (1995), the U.S. Congress has agreed to federal restrictions on any research that would require harm or destruction of the human embryo. This restriction was partially lifted in 2001 by President Bushs announcement that research with stem cell lines existing as of August 9, 2001 could be eligible for federal funding.

Subsequently, President Obama annouced a new approach to approving stem cell lines for federal funding (Obama, 2009). The question now is not whether stem cell lines were created before a particular date, but whether or not those lines meet criteria that have been defined for ethically derived stem cell lines (NIH, 2009). While the result has been an increase in the number of stem cell lines approved for federal funding, it is noteworthy that the number of lines meeting these criteria is limited (NIH Human Embryonic Stem Cell Registry). In fact, many of the lines approved under the Bush policy are not acceptable under the Obama guidelines.

It would be a mistake to assume that religion is the only basis for arguments against hESC research. It is clear that some individuals and groups are motivated more by philosophical, political, or even economic arguments. However, whether based on religion or otherwise, most polls show that opponents to hESC research may represent a minority, but that minority is substantial in size and in impact (e.g., pollingreport.com).

Stem cells can be obtained from embryos, but embryos are only one of many potential sources. In the fetus, and even in an adult, stem cells can be found in many body tissues. The best known of these sources is bone marrow, in which stem cells are produced that are capable of differentiating into different types of blood ells. However, these stem cells are not pluripotent as defined above. Such cells are often called adult or tissue-specific stem cells. These cells have important, but restricted, clinical applications distinct from the wider range of possibilities with human embryonic stem cells (Wood, 2005).

Several sources of pluripotent stem cells have now been identified. One of these sources is based on the technology used to clone Dolly the sheep (Campbell et al., 1996), Snuppy the dog (Lee et al., 2005), and many other mammalian species. The first step to cloning these animals is a technique called Somatic Cell Nuclear Transfer (SCNT). SCNT in any species begins with an egg of that species from which the genetic material is removed. This egg can then be fused with an adult cell of the individual to be cloned. The result is an egg that now contains a full complement of DNA. Under appropriate laboratory conditions, that egg can be induced to divide as if it were a fertilized egg. If allowed to progress far enough, the resulting embryo can be implanted in the uterus of an individual of the same species, potentially resulting in the birth of a clone. However, it is also possible to allow the embryo to develop only for the purpose of harvesting stem cells rather than implantation. This source of stem cells is particularly important for stem cell research as well as potential therapies because of the opportunity to produce stem cells and differentiated cells that are genetically and immunologically matched to the adult donor.

Until 2005, researchers had been frustrated in their attempts to duplicate with human cells the same success achieved with SCNT in many other mammalian species. Some researchers were considering the possibility that SCNT in humans would be for all practical purposes impossible. This view was apparently proven wrong when the laboratory of Dr. Hwang Woo Suk published a report demonstrating successful derivation of stem cell lines from eleven separate cases of human SCNT (Hwang et al., 2005). Hwang, whose laboratory had cloned the first dog (Lee et al., 2005), was seen as so far ahead with SCNT that other laboratories around the world suspended attempts to achieve human SCNT, choosing instead to collaborate with Hwangs laboratory. Unfortunately, the story began to unravel in late 2005 and by the next year it was clear that the results announced in Dr. Hwangs paper were entirely falsified (Kennedy, 2006). Because researchers throughout the world had chosen to not pursue SCNT, this line of research was set back a year or more. It wasnt until 2008 that scientists at Stemagen successfully reported human SCNT (French et al., 2008)

Although SCNT has both scientific and therapeutic benefits, it still raises significant ethical questions, particularly because it depends on women who are willing and able to donate some of their eggs. Egg donation is not free of risk and, therefore, many bioethics committees and regulatory bodies have decided to err on the side of caution by prohibiting payment for eggs donated for the purposes of stem cell research. While on the one hand this position might be seen as paternalistic, the case can be made that any significant payment might lead those who are young or poor to overlook the possible risks of donation. The debate about payment is likely to continue, but it is clear that SCNT depends on a resource (human eggs) that is in limited supply and that can be obtained only through a time-consuming and invasive procedure.

An ongoing hope is that pluripotent cells might be found without the need for either human embryos or eggs. A number of reports have suggested that such cells might be found, for example, in amniotic fluid (De Coppi et al., 2007) and testes (Conrad et al., 2008). Another approach, reprogramming of adult cells, has been found to be far easier than expected and provisionally as good as or better than other sources of cells. In brief, cells (e.g., fibroblasts) are obtained from an individual, treated with a viral vector to introduce as few as 4 genes which, effectively, dedifferentiate (reprogram) the cells to become pluripotent stem cells (Takahishi et al., 2007; Yu et al., 2007). These cells are now commonly referred to as induced pluripotent stem (iPS) cells. Although these findings are intriguing, it remains to be seen whether the various alternative sources of pluripotent stem cells will prove to have the same qualities as the stem cells derived from human embryos (Hyun et al., 2007).

In just ten years (1998-2008), the field of human embryonic stem cell research evolved rapidly. Almost certainly, because of intense public scrutiny, the landscape for regulations and guidelines has also evolved rapidly. Unfortunately, the regulatory environment for this research varies not only across international borders, but significant differences are found even among the states of the United States. It is neither useful nor possible to describe regulations in each of these jurisdictions both because of extensive variation and because regulatory changes continue to be driven by changing public opinion and rapid advances in the sciences. However, a few examples are useful to illustrate the complex and often conflicting approaches to stem cell research across international and interstate borders.

Internationally, the environment for stem cell research ranges from a virtual prohibition to a near absence of restriction (Isasi and Knoppers, 2006). Several countries, including Austria, Norway, and Poland, have prohibited any human embryo research. Others, such as the U.S. and Germany, prohibit the use of federal funds for hESC research, but in the face of public pressure both countries have adopted national policies that allow the use of federal funds for stem cell lines created before August 2001 and May 2007, respectively. Finally, for all practical purposes, China and Singapore are examples of countries with relatively few restrictions on hESC research.

The variation across international borders in stem cell regulations should not be taken as a sign that the international stem cell community has been silent about the responsible conduct of stem cell research. The International Society for Stem Cell Research (ISSCR), (one of the leading international stem cell research organizations, has established a variety of guidelines that are now widely accepted throughout the stem cell research community (ISSCR, 2006). Key principles of these guidelines are:

While the U.S. has significant restrictions on the use of federal funds for stem cell research, such research is still permitted to the extent allowed under state laws. As with international stem cell regulations, tremendous variation can be found among different states (National Conference of State Legislatures, 2008). As of 2008, South Dakota prohibits hESC research, while some states (e.g., California, New York) have been not only permissive of stem cell research, but have approved significant public funding dedicated to hESC research.

The fact that some states are highly permissive of stem cell research does not mean that such research occurs in the absence of either regulations or guidelines. Nationally, guidance that is generally accepted has come from the National Academy of Sciences. Following their initial report (Committee on Guidelines for Human Embryonic Stem Cell Research, 2005), the NAS has published amendments in 2007 and 2008 (Human Embryonic Stem Cell Research Advisory Committee, 2007 and 2008). Two key points in those guidelines are:

One of the states that has been most receptive to hESC research is California. In 2004, a significant majority of California voters approved Proposition 71, creating a mechanism for allocating $3 billion for stem cell research over a 10-year period. This voter approved initiative also put in place a framework to promote scientific, legal and ethical oversight for stem cell research through the creation of the California Institute for Regenerative Medicine (CIRM). The resulting requirements for CIRM-funded research have generally been extended to all stem cell research in California. Under California law (California Institute for Regenerative Medicine, 2008), key requirements for stem cell research include requirements for review of the research by the equivalent of an ESCRO Committee, criteria for acceptable derivation of materials that are to be used for research use, and categories of research that are specifically prohibited.

Case Study #1

Clearly, from an ethical perspective, stem cell research constitutes one of the most complex of the numerous domains of research. Many considerations might be listed here, but three seem to be particularly noteworthy.

Chimeras: A chimera is defined in various ways, but the principle is that one organism consists of components that are demonstrably derived from two or more distinct species. The name chimera comes from a monster in Greek mythology that was a combination of different animals (typically a lion, goat, and snake). In biology, chimeras can now be formed either by inserting cells from one species into the adult of another species, or by creating an embryo that begins with cells from two or more species. In principle, it seems that our society already accepts the possibility of saving a childs life by replacing a defective heart with one that is non-human (e.g., a baboon heart, Altman, 1984), but we are much less comfortable with creating a non-human animal that might have human features (e.g., a human face, ear, or hand). Having the appearance of a human is problematic more because of our discomfort than because it necessarily raises some direct ethical dilemma. However, we have reason to be much more concerned about a human nervous system (i.e., do we have a risk of a non-human animal achieving levels of awareness and understanding that would make it sufficiently human to be deserving of human protections?) or human gametes (i.e., do we have a risk of two non-human animals reproducing with human gametes, thereby producing a human, or largely human, organism?). These questions are very much hypothetical and, if not impossible, highly improbable under the circumstance that the ethical, legal, scientific, and social environment is not one that favors these goals. Nonetheless, responsible science and policy require that one concern for reviewers of stem cell research is to address the potential risks with experiments that involve the mixing of stem cells from two or more species.

Clinical Trials: In the very near future, we are likely to see clinical trials based on reputable, pluripotent stem cell research. We are already seeing numerous stem cell "trials" worldwide that are arguably questionable, and sometimes criminal. By taking advantage of public awareness of and excitement about stem cell research, it is now possible to find groups that will offer to treat or cure almost anything in the context of a clinical "trial" that typically has no control group and for which participants must pay for participation. Payments for such "trials" are often on the order of $10,000 or more. Whether intentional or not, these trials are likely to be scams with little chance of success. Particularly under these circumstances, the stem cell field must meet a higher than average standard before approving the first clinical trials with this very new approach to treating disease. To do otherwise risks a backlash against all of stem cell research if initial trials unexpectedly result in a worsening of disease, serious side effects, or even death. All of these are possible outcomes no matter how much work has been done before the first trials in humans. Therefore to decrease that risk the scientific community can and should set a high bar both for the circumstances under which such a trial should be attempted and for the design of the research study to ensure the highest level of protections for informed consent and the welfare of the research participants.

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Stem Cells - Resources for Research Ethics Education

Presenter: Michael Leon, PhD, Professor and Associate Dean, Department of Neurobiology and Behavior, Center for Autism Research and Translation, Center for the Neurobiology of Learning and Memory, The University of California, Irvine, California. Location: Sanford USD Medical Center Schroeder Auditorium Avera Education Center Classroom 2 (Avera sites dial in to 8103502) The VA Hospital Room 351, and registered video conferencing sites

Presenter: Sam Milanovich, MD, Assistant Professor, Department of Pediatrics, University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota. Location: Health Science Center Room 106 Sioux Falls, SD Avera Education Center Classroom 2 (Avera sites dial in to 8103502) The VA Hospital Room 351, and registered video conferencing sites

Presenter: Jenny Miller, DC, Chiropractor/Acupuncture, Sioux Falls VA Hospital Location: VA Education Center, Building One, Room #123, Sioux Falls, South Dakota

Presenter: Jerome Freeman, MD, FACP, Professor and Chair, Department of Neurosciences, University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota Location: Sanford USD Medical Center Schroeder Auditorium, Avera Education Center Classroom 3 (Avera sites dial in to 8103502) The VA Hospital Room 351, and registered video conferencing sites

Presenter: Anthony Sierra, MD, Clinical Professor, Department of Obstetrics and Gynecology, University of South Dakota Sanford School of Medicine, Sioux Falls, South Dakota Location: Schroeder Auditorium, Sanford USD Medical Center Sioux Falls, South Dakota

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Sanford School of Medicine | USD - University of South Dakota

When people come down with cancer, they submit to regimens of drugs and, if need be, harsh radiation treatments. But what if those patients could forego all of this and ward off their cancers with their own white blood cells? An experimental white-blood-cell-transfusion approach that Dr. Dipnarine Maharaj is developing might make that feasible.

Dr. Maharaj is a hematologist and oncologist at the South Florida Bone Marrow/Stem Cell Transplant Institute, a cancer treatment center that applies stem-cell therapies to cancers that have not responded well to other treatments. He is working on taking white blood cells from healthy donors and fusing them into patients with cancer, so that the transfused cells can stimulate the patients immune systems and enable them to ward off the cancers on their own.

His concept has precedentsdoctors successfully treat some other types of infections by transfusing white blood cellsand the initial experimental results are promising. He will need more time, however, and much more funding before his treatment approach is ready. Dr. Maharaj described his research to Rick Docksai, associate editor for THE FUTURIST, in the following interview.

Dr. Dipnarine Maharaj (photo credit: BMSCTI.org)

THE FUTURIST: Strengthening the body to wage its own fight against cancer, instead of relying on drugs or radiation, is certainly an appealing idea. What first drew you to it?

Dipnarine Maharaj: We asked the question, why is that some people get cancer and others dont? The answer is that someone whos got cancer, their immune system is broken down. So if the people who didnt get cancer, their immune systems are not broken down, how can we fix the cancer patients immune systems? Im a stem-cell physician, and weve had this procedure for many years where we use a patients own stem cells or the stem cells of a donor to reform the patients own immune system. Thats what actually helps to cure the cancer.

THE FUTURIST: How does your new approach go about boosting the bodys immune cells? What mechanisms are involved?

Maharaj: To cure cancer, we really have to repair the immune system. What were trying to do is apply that same knowledge to treat patients with solid tumors. The method Im using, were taking cells of the immune system from the donors, and were transfusing those cells into patients who have cancers. It is essentially a white-blood-cell transplant.

THE FUTURIST: How early in the progression of cancer would a patient need to be for the treatment to work effectively?

Maharaj: Were still under the clinical trials. But the best way I could answer that question is that the smaller the amount of disease at the time that it is done, the better the chance of a positive outcome.

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A Natural Cure for Cancer?: THE FUTURIST Interviews Dr ...

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(From left to right) Archbishop Forte, Cardinal Luis Tagle, Cardinal Peter Erdo, Cardinal Ricardo Ezzati Andrello, and Father Federico Lombardi speak at the press conference announcing the mid-term report on the Synod on the Family on October 13, 2014.

Hungarian Cardinal Peter Erdo, general relator of the Synod, presents his interim report at a Vatican press conference October 13, 2014.

ROME The Vaticans interim report on the debates at the Extraordinary Synod on the Family, released in Rome this morning, includes a range of controversial proposals that are eliciting strong reactions, including a statement from the Voice of the Family coalition charging that it amounts to a betrayal of the Catholic faith.

The document, which is not definitive and is merely meant to summarize the debates of the first week, asks whether accepting and valuing [homosexuals] sexual orientation could align with Catholic doctrine; proposes allowing Communion for divorced-and-remarried Catholics on a case-by-case basis; and says pastors should emphasize the positive aspects of lifestyles the Church considers gravely sinful, including civil remarriage after divorce and premarital cohabitation.

After the document, known as the relatio post disceptationem, or report after the debate, was read in the Synod hall this morning, numerous bishops reportedly rose to raise concerns or ask for clarification.

Cardinal Peter Erdo, the synods general relator and thus the documents lead author, told a press conference at the Vatican this morning that some bishops questioned why the document fails to mention Church teaching that homosexual unions are disordered. Vatican reporter John Thavis, who describes the document as a pastoral earthquake, wrote that at least one bishop asked what happened to the concept of sin, noting that it is hardly mentioned in the document.

The document has drawn strong praise in mainstream media and from liberal Catholics. Joshua McElwee, the Vatican correspondent for the leftist National Catholic Reporter, commented on Twitter, "Reading this#Synod14document, I don't know what to say. It feels like a whole new church, a whole new tone, a whole new posture. Wow."

Fr. James Martin, SJ, tweeted: "Today's stunning change in tone from the Catholic bishops on LGBT people shows what happens when the Holy Spirit is let loose.

However, it has also met a sharp rebuke from Catholic activists. John Smeaton, co-founder of Voice of the Family, a coalition of 15 international pro-famiy groups, said it is one of the worst official documents drafted in Church history.

Thankfully the report is a preliminary report for discussion, rather than a definitive proposal, he said in a press release. It is essential that the voices of those lay faithful who sincerely live out Catholic teaching are also taken into account. Catholic families are clinging to Christs teaching on marriage and chastity by their finger-tips.

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South Dakota Senate Rejects Effort to Undermine Embryonic ...

The South Dakota Embryonic Stem Cell Research Measure is an initiated state statute that did not appear on the November 2, 2010 ballot. The proposed measure proposed easing restrictions on stem cell research.[1]

In an effort to avoid a "costly ballot initiative," supporters sought a legislative repeal, however on February 3, 2010 the South Dakota State Senate rejected the measure 21 to 12. Supporters had until April 6, 2010 to submit a minimum of 16,776 valid signature to place an initiated state statute on the ballot.[2]

According to the South Dakota Secretary of State, if the measure had been approved for the ballot, there was a 36% success rate in passing initiated measures.[3]

The measure was supported by former state Treasurer David Volk, a cancer survivor. Volk said that he wanted the state's regulations on funding stem cell research to be thrown out. According to reports, adult stem cells were currently being used to help cancer, Diabetes and Alzheimer patients. A group was created in support of the measure called South Dakotans for Lifesaving Cures. The group planned to file ballot language paperwork with the South Dakota Secretary of State.[4]

Abortion opponent, Rep. Roger Hunt said that the measure was likely to see "considerable opposition" and predicted that the South Dakota Legislature may even address the issue during it's session.[1]

The Coalition for Cures Not Cloning was opposed to the proposed measure. The group was led by Dr. Mick Vanden Bosch, Rep. Manny Steele and former legislator Mary Glenski. Both the Coalition for Cures Not Cloning and the Family Policy Council. They argued that the "the proposed measure would drive a Texas-sized loop hole in South Dakotas current cloning ban that was passed in 2004. Make no mistake, this measure uses sleight of hand to rewrite the definition of cloning."[3]

Dr. Bosch, an opthalmologist said, "As a board certified physician, I can tell you that regardless of what others say, this initiated measure allows what is medically defined as cloning...If this measure passes, research dollars currently in effective research could be redirected to areas that have not yielded any positive results in countries where they have been tried."[3]

If petition language had been approved for circulation a minimum of 16,776 valid signatures were required by April 6, 2010.[4]

d South Dakota Abortion Ban Initiative (2008)

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South Dakota Embryonic Stem Cell Research Measure (2010 ...

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