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Statement Urging Direction of State Dollars to Ethical Research that Works

By Nancy E. Paltell, Ph.D., Associate Director of Respect for Life

House Appropriations Subcommittee, 02/26/09

This statement, urging that the Stem Cell Research Fund be limited to research conducted with umbilical cord blood and adult stem cells, including induced pluripotent stem cells, is conveyed on behalf of the Catholic bishops serving Maryland and their dioceses.

The journal, Science, named the creation of induced pluripotent stem cells (iPS cells) as the scientific breakthrough of 2008. Scientists have learned how to take ordinary adult skin cells and turn them into pluripotent stem cells. The skin cells are reprogrammed to behave like embryonic stem cells, but no embryos are required. This is the breakthrough everyone has been waiting for, but no one thought it would come this soon.

All over the world, scientists have been conducting studies to learn if iPS cells really are the same as embryonic. The results show that iPS cells are actually better because they solve several of the major issues that plague embryonic stem cells. The iPS cells are readily available, easy to obtain, are free of the ethical issues associated with embryonic stem cells, and iPS cells are patient-specific. Because iPS cells come from a patient’s own body, the cells are genetically matched, and there’s no chance of the body’s immune system rejecting the cells. The latter is a serious issue with embryonic stem cells.

The Feb. 9, 2008 issue of TIME magazine chose the creation of iPS cells as its cover story. Below are some quotations from that article.

“Harvard is at the vanguard, brining the newest type of stem cells, which do not rely on embryos at all, closer to the clinic, where patients will actually benefit.”

“No need for eggs, no need from embryos. Could it be that easy? Were the debate and controversy over embryonic stem cells now rendered moot? ‘It was unquestionably unexpected,’ says [Harvard researcher] Melton of the breakthrough.”

“At about the same time [as the discovery in Japan], in Wisconsin, Thomson achieved the same feat using a different cocktail of genes. With those studies, what became known as induced pluripotent stem cells (iPS cells) were suddenly a reality. Never mind the frustratingly fickle process needed to create embryonic stem cells; this was something any molecular-biology graduate student could do.”

“The iPS technology is the ultimate manufacturing process for cells; it is now possible for researchers to churn out unlimited quantities of a patient’s stem cells, which can then be turned into any of the cells that the body might need to repair or replace.”

The Annual Report of the Maryland Stem Cell Commission includes abstracts of the projects that were awarded funding. Below are quotes from three Johns Hopkins scientists who were awarded 2008 exploratory grants to study iPS cells:

Fred Bunz, Johns Hopkins University, $230,000, for a proposal to explore generation of iPS cells: “Among the most promising developments in biomedical science has been the recent demonstration that normal cells can be reprogrammed into stem cells, i.e., cells that can develop into any tissue in the body. The derivation of stem cells from adult cells – rather than from embryos – would circumvent both technical and ethical obstacles to developing stem cell-based therapies.”

Chi V. Dang, Johns Hopkins University, $230,000, for a proposal to map human stem cellness transcriptional networks: “The OCT4 and SOX2 genes are master switches that are not only known to maintain the pluripotency of human embryonic stem cells, but they are also capable of converting an adult skin cell to a pluripotent stem cell that has virtually all known characteristics of a human embryonic stem cell.”

Piotr Walczak, Johns Hopkins University, $230,000, for a proposal to evaluate skin-derived pluripotent stem cells: “With significant progress being made in developing stem cell therapies, it is important to focus on the key features important for treatment of a large population of patients. First, the cells must be accessible in large quantities, sufficient for therapy for all patients affected by the disease. Second, the cells must be identical immunologically to the cells of the individual patient otherwise the cells are eliminated by an immune response, which is only hindered by toxic treatments that are directed at protection of the transplanted cells by suppressing an immune response. Presently scientists are pursuing methods that generate embryonic stem cells from normal adult human cells and several laboratories have reported a great deal of success in doing so. If the properties of these induced stem cells are truly the same as those of embryonic stem cells, it would not only allow help to resolve the ethical controversy associated with obtaining human embryonic stem cells, but it could provide an unlimited source of stem cells without the need for immunosuppression.”

Clearly, funding research using iPS cells should be a priority for this state.

Another priority should be investing as much of our limited research dollars as possible into research that is already helping patients or is the closest to helping patients. At the First Maryland Stem Cell Research Symposium, held Dec. 3rd, several amazing research projects were presented, either verbally or at the poster session. The research that was either helping patients or poised to start a clinical trial involved adult stem cells.

Below are quotes from three abstracts, researchers who received grants in either 2007 or 2008:

Hamid Rabb, Johns Hopkins University, a 2007 awardee, $230,000, for his research in kidney disease using ADULT stem cells: “ These data demonstrate that techniques developed in murine [mouse] models to isolate and expand adult kidney stem cells are feasible in humans. Further expansion and in depth in vitro and in vivo characterization of these adult human kidney derived stem cells will set the stage for therapeutic trials in patients, including those with acute kidney injury, severe acute rejection, and chronic allograft nephropathy.”

Sergei Atamas, University of Maryland, Baltimore, a 2008 awardee, $224,750, for his research in bone and tendon healing using ADULT stem cells: “We have treated more than 120 patients already, and such treated patients heal significantly quicker.”

Stephen Baylin, University of Maryland , Baltimore, a 2008 awardee, $1,725,000, for his proposal to try to solve a major problem with embryonic stem cells, the tumor issue: “all experimental evidence shows they [embryonic stem cells] have a potential to generate tumors over time.”

Note that the first two grants, already showing success, were very small, only $200,000, and relied on adult stem cells for success. The massive grant of $1.7 million is for a project to try to make embryonic stem cells as good as adult stem cells, to try to figure out how to stop embryonic stem cells from forming tumors.

Worldwide, there are no clinical trials using embryonic stem cells because embryonic stem cells form tumors. Attached to this testimony is a table showing just some of the conditions being studied in clinical trials using adult/umbilical cord stem cells, clinical trials that are going on right now and are funded by the NIH. There are currently 1,187 clinical trials using adult or umbilical cord stem cells, while there are zero clinical trials using embryonic stem cells.

California has invested $3 Billion into embryonic stem cell research, and has little, if anything, to show for it. Ohio has invested just $27 million into the creation of the Center for Stem Cell and Regenerative Medicine, and has become a center of excellence, a model for the country. Ohio’s multi-institutional center is promoting cutting-edge research which is translating into clinical and commercial applications, none of which relies on embryos – their bench-to-bedside approach uses solely non-embryonic stem cells, including adult stem cells and stem cells derived from umbilical cord blood.

Maryland’s reputation as a leader in biotechnology would greatly benefit from steering the money set aside for stem cell research to the research that holds the most hope for treating patients and has the greatest potential for commercial applications: umbilical cord blood and adult stem cells, including induced pluripotent stem cells. We urge the acceptance of the following budget language:

T50T01.03 Stem Cell Research Fund
General Fund Appropriation, PROVIDED THAT FUNDING SHALL BE LIMITED TO RESEARCH CONDUCTED WITH UMBILICAL CORD BLOOD AND ADULT STEM CELLS, INCLUDING INDUCED PLURIPOTENT STEM CELLS.