By Maria Wiering
This is part two of a series. To read part one of the series, click here.
Linda Kosinski, 43, was in need of a bone marrow transplant in 2007, after being diagnosed with an uncommon form of leukemia. Nothing on the national bone marrow registry was a match, and despite three bone marrow drives in as many states, the Elkton resident was left with a poor prognosis and without a donor.
Through Internet research, her husband found a California hospital willing to treat Linda with stem cells from umbilical cord blood in a clinical trial. In 2008, Kosinski underwent the treatment and is in remission today. She credits it with saving her life.
Scientists have been researching stem cells for more than 50 years because of their potential to develop into many different cell types, opening doors to new regenerative therapies and cures.
According to Dr. Andrew Pecora, stem cells are going to change the world.
“We will figure out – in easy, simple ways – how to reprogram stuff so that old stuff becomes young stuff, broken stuff becomes fixed stuff, and your life goes on,” he said.
Chief medical officer and director of NeoStem, a New York-based international biopharmaceutical company that works with stem cells, Pecora described the 21st century as “the century of biology,” where “the essence of life is understood.”
“I’ve always been interested in using human cells to treat human disease. We all start as a single cell, and that cell has everything it needs to create an entire human that can live up to 100 years or more,” he said. “There’s an incredible power in every cell in our body. At some point, that will be the ultimate source of how we treat illness.”
Already, stem-cell clinical trials are treating a swath of cancers and degenerative diseases such as sickle cell anemia and Lou Gehrig’s Disease, according to the National Institutes of Health, which is based in Betehesda.
Muddling stem-cell research’s promise, however, are ethical concerns over one stem-cell source: human embryos. To obtain embryonic stem cells, researchers must destroy a human embryo, a fertilized human egg.
The Catechism of the Catholic Church (No. 2274) states, “Since it must be treated from conception as a person, the embryo must be defended in its integrity, cared for, and healed, as far as possible, like any other human being.”
Quoting “Donum vitae,” a 1987 document from the Congregation for the Doctrine of the Faith, the Catechism adds, “It is morally impermissible to produce human embryos intended for exploitation as disposable biological material.”
Embryos are not the only stem-cell source, and are perhaps the least promising for treatment-oriented research. So far, all successful human treatments have been achieved with adult stem cells, rather than embryonic stem cells. Research into the latter, the NIH states, is still “in its basic stages.”
This is affirming for pro-life advocates, who oppose embryonic stem-cell research on the same grounds they oppose abortion.
Adult stem cells, such as those that saved Kosinski, can be found in many tissues and blood. Unlike regular adult cells, which are specialized to the particular tissue they comprise, such as the heart, these cells are capable of becoming many different types of cells and can be used to repair damaged cells in other parts of the body.
Embryonic stem cells are different, as they are capable of becoming every type of cell, a quality called “pluripotency.”
Embryos, however, are no longer the only source for pluripotent stem cells. In 2006, researchers discovered how to reprogram regular adult skin cells to an embryonic stem-cell-like state, effectively turning back time on the cells’ development.
Pecora predicts that moment will prove pivotal, like mankind’s discovery of fire.
These cells, called induced pluripotent stem cells, or IPS cells, are thought to offer the same flexibility as embryonic stem cells, but without the ethical baggage. Research is under way in labs around the world to unlock their potential.
“This is a discussion of what’s practical,” Pecora said. “It’s practical to move ahead with adult stem cells. There’s no moral dilemma, they’re more plentifully available, they’re more easy to work with, and they seem to work in a variety of areas. Why even go down that other road (of embryonic stem-cell research) if it may not be needed? Now superimpose on that all of the moral issues.
“At first, we thought we had to have the embryonic stem cells because of the science, but now we know with IPS cells we can mimic most of the science – maybe not all of it, but most of it,” he said. “It just made it a lot easier discussion.”
Maryland, Stem-Cell Capital?
In 2009, Governor Martin J. O’Malley told scientists gathered for a World Stem Cell Summit in Baltimore that it was his “goal and vision to make Maryland the most welcoming environment for stem-cell research … not just in the United States of America, but in the world.”
In 2006, when Robert L. Ehrlich Jr. was in the State House, the Maryland General Assembly established the Maryland Stem Cell Research Fund, pouring $91.2 million over six years into 258 projects the MSCRF selected. The Legislature awarded the fund $10.4 million for its 2014 budget.
“It was created to spur research as well as biotechnology, as well as collaboration between research institutes and companies, and to advance the field of stem-cell research,” said Dan Gincel, MSCRF executive director.
The fund “is a clear investment in our future,” he said.
“We have great scientists we want to keep in our state, and we want to give them the tools to do the innovative research that they do,” he said. “If we don’t invest right now, we’re not going to have the (resulting) drugs 15 to 20 years from now.”
The MSCRF has funded 258 research projects in the state, with a focus on research in its early stages to encourage “the innovation of new ideas” and attract investors, Gincel said. Many of its funded researchers are from The Johns Hopkins University, University of Maryland College Park, University of Maryland Baltimore and University of Maryland Baltimore County.
The state began funding stem-cell research at a time when federal monies were unavailable for new embryonic stem-cell lines. In 2001, President George W. Bush issued an executive order stopping federal funding for research involving the destruction of an embryo, but permitted research to continue on embryonic stem-cells lines created before Aug. 9 of that year.
In March 2009, President Barack Obama lifted the funding ban on new embryonic stem-cell lines in the name of expanding research.
Gincel thinks of stem-cell research as the “fourth pillar” of the U.S. health care industry, along with pharmaceuticals, biotechnology and medical devices. Stem-cell research affects all of those fields; it applies to drug development, cell therapy and medical device creation and implant rejection issues.
Currently, no approved stem-cell products are on the market in the United States, Gincel said. The promising drugs and therapies are still in clinical trials.
That could change soon, thanks to Columbia-based Osiris Therapies. Its drug Prochymal has been shown to help patients with Crohn’s disease and acute graft-vs.-host disease, and is being fast-tracked by the U.S. Food and Drug Administration, according to Osiris’ website.
Canada approved its use last year, making Prochymal “the world’s first approved stem-cell drug,” according to the company.
Research is also under way in Maryland hospitals, including The Johns Hopkins University and the University of Maryland. At Mercy Medical Center in Baltimore, plastic and reconstructive surgeon Dr. Craig Vander Kolk is researching how adult stem cells in fat can improve breast and facial reconstruction. Currently, his research is solely supported by his department at Mercy.
With adult stem cells, “you’re using your own tissue from your own body, so there’s no rejection,” Dr. Vander Kolk said. “It’s just an exciting field.”
A funding ‘disgrace’
Gincel views Maryland as well-established in the area of stem-cell research, between the MSCRF and local companies working in the field. He points to Lonza Biologics, a large stem-cell manufacturing company in Walkersville; Life Technologies, which bases its research-and-development branch in Frederick; and Becton, Dickinson and Company, a global medical technology company whose education center in Rockville trains customers in bioimaging.
“We’re very attractive for new start-up companies to come here and establish themselves,” Gincel said.
Nancy Paltell, Maryland Catholic Conference associate director for respect for life, adamantly disagrees. When it comes to successful clinical trials, she said Maryland “is kind of stuck in the Dark Ages.”
About 25 percent of MSCRF funds from 2007 to 2012 have supported induced pluripotent, or IPS, cells. Slightly more than 25 percent has gone to adult stem cells. Other funding has gone to work with cancer stem cells or multiple stem cells, according to the fund.
Just under 25 percent of the MSCRF funding goes into embryonic stem-cell research. That equals almost $23 million dollars, every dime of which Paltell calls “a disgrace” and “a disservice to the patients of Maryland who are counting on this research to come up with cures.”
“This isn’t about Nobel prizes and cool science, this is about medical treatment,” she said.
Because adult stem cells have produced successful human therapies – and, to date, embryonic cells and IPS stem cells have not – Paltell argues that state and federal funding should focus on adult stem-cell research aiming for clinical trials. She has advocated for legislation designed to push the MSCRF in that direction.
“Adult stem cells are being used all over the world to save lives,” she said. “There are about 2,000 adult stem-cell clinical trials going on in the United States. … How long are you guys going to dink around in a petri dish when you have people dying?”
Paltell points to scores of clinical studies with adult-stem-cell-based therapies in other states, such as Linda Kosinski’s cord blood transplant in California, and she thinks Maryland should be home to success stories, not pre-clinical research, especially with embryonic stem cells.
An embryo’s right to life
The Catholic Church is no outside observer to stem-cell research. In April, the Vatican hosted its second International Stem Cell Conference to bring together scientists, religious leaders, politicians, media and students to discuss adult-derived stem-cell therapies.
Among conference presenters was John B. Gurdon, winner of the 2012 Nobel Prize for Physiology or Medicine for his pioneering work creating IPS cells with fellow researcher Shinya Yamanaka. Osiris Therapeutics’ president and CEO C. Randal Mills also attended.
NeoStem’s Pecora was also among the presenters. His company and its nonprofit, Stem for Life Foundation, partnered with the Pontifical Council for Culture to host the event.
The Vatican, incidentally, also teamed in 2010 with the University of Maryland and two other Italian institutions with the intention of pursuing adult stem-cell research, but the relationship dissolved due to lack of funding, according to a University of Maryland spokesperson.
The church is not alone in its concerns about the morality and ethics of embryonic stem-cell research. Dr. Andrew Seigel, an attorney and research scholar at the Johns Hopkins Berman Institute of Bioethics in Baltimore, said scientists still wrestle with the destruction of human embryos.
Seigel worked on the staff of President Clinton’s national bioethics commission from 1998 to 1999, during the first reports of the isolation and culturing of embryonic stem cells. The commission was asked to explore the ethical issues surrounding the issue. He now sits on Johns Hopkins’ Institutional Stem Cell Research Oversight Committee, which reviews protocols for stem-cell research.
The growing use of induced pluripotent stem cells instead of embryonic stem cells may phase out that ethical quandary, Seigel said. According to Gincel, the interest in IPS cells has reduced the amount of Maryland’s public funding directed to embryonic stem cells.
Interest in embryonic stem-cell research may wane, but is unlikely to disappear, Pecora said.
“From a scientific perspective, there are still things to learn” from embryonic stem cells, he said.
That could mean no new embryos need to be destroyed for research, but the Catholic Church still opposes research on stem-cell lines derived from human embryos, according to a 2000 Pontifical Academy for Life document.
“Nothing should be done to an embryo that couldn’t ethically be done to an adult,” said Father Tadeusz Pacholczyk, a neuroscientist, ethicist and director of education at the National Catholic Bioethics Center in Philadelphia.
Speaking on a Catholic radio program April 24, Father Pacholczyk said that human life is “an infinite good.”
“We cannot take advantage of fellow humans,” he said. “At no point along the spectrum will it ever be defensible to treat those humans who are our brothers and sisters as if they are objects by which we can pull out spare parts to do our research.”
Not all ethicists agree. The embryo is 5 to 7 days old when stem cells are extracted, an always fatal process. Some argue an embryo that young may be human, but without a right to life. They disagree on which qualities confer that right to life, but point to self awareness, the capacity for reasoning and or ability to act in the world.
The argument is problematic, even for secular ethicists, Seigel said, because the characteristics cited that confer “higher moral standing” are also lacked by infants, people in a coma, people with severe intellectual disabilities and some elderly people.
“Some say that there is no way to be consistent on that, and there’s no way to draw a non-arbitrary line between human embryos and these other human beings we do ascribe a right to life to,” Seigel said. “If we can’t draw a non-arbitrary line between those different human beings, then human embryos should be viewed as having a right to life.”
(Seigel made clear he was outlining the position for the sake of argument, not presenting his own view.)
Some argue that embryos deserve respect, but that sacrificing them for the possibility of cures is a worthy use for embryos that otherwise might be thrown out or frozen indefinitely, if leftover from in vitro fertilization treatments.
Father Pacholczyk said that even if all the diseases in the world could be cured with the killing of one embryo, it would be morally impermissible. The same holds for killing one adult for the same ends. The ends do not justify the means.
After all, an adult, he said, is “nothing more than an overgrown embryo.”
When awarding grants, Gincel said the MSCRF takes ethical issues seriously, from the type and number of stem cells used, to the role of animals and issues of donor consent.
Four of the MSCRF commission members are bioethics experts, including two with expertise in religion. One is a Catholic priest, Father Kevin T. FitzGerald, associate professor in the Department of Oncology at Georgetown University Medical Center in Washington, D.C.
As to whether it would be right or wrong for a person ever to use a treatment developed with embryonic stem cells, the question is hard to answer, but “skates close to thin ice” in relation to “material cooperation with evil,” said Monsignor David Fulton, who teaches medical and bioethics at St. Mary’s Seminary and University in Baltimore.
For now, the scenario remains a hypothetical, but it may parallel the current use of vaccines derived from fetuses aborted decades ago. According to the National Catholic Bioethics Center, “One is morally free to use the vaccine regardless of its historical association with abortion. The reason is that the risk to public health, if one chooses not to vaccinate, outweighs the legitimate concern about the origins of the vaccine.”
Monsignor Fulton said descriptions of embryonic stem-cell research can collapse the means into the consequence, such as “searching for a cure,” and obscure what is really happening – in this case, the destruction of human life for research.
“Some things are so important that we can’t allow that collapse to happen,” he said.
Copyright (c) May 5, 2013 CatholicReview.org