As President-elect Donald Trump prepares to take office, scientists are anxiously waiting to see if his policies will affect ongoing scientific research that utilizes embryonic stem cells or fetal tissue.
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Both embryonic stem cell research and fetal tissue research have faced either backlash or federal funding restrictions in recent decades.
Alta Charo, a professor of law and bioethics at the University of Wisconsin, said that at this point, not enough has been said by Trump to give a clear indication about whether any restrictions could be reintroduced.
"It's all a little bit like using a Ouija board," Charo, co-chair of the National Academy of Medicine Forum on Regenerative Medicine, said about the upcoming administration. However, she suggested looking to Vice President-elect Mike Pence for some clue as to how the administration might view research.
Treatment Using Stem Cells
The field of embryonic stem cell research faced federal funding restrictions under President George Bush that were later removed under President Barack Obama. In 2009, after Obama removed restrictions on federal funding for stem cell research, Pence wrote an op-ed for The Hill calling embryonic stem cell research an “empty promise.”
“I am a Christian who believes that life begins at conception and that a human embryo is human life,” Pence wrote. “Therefore, I believe it is morally wrong to create human life to destroy it for research. Not only that, I believe it is morally wrong to take the tax dollars of millions of pro-life Americans, who believe that life is sacred, and use it to fund the destruction of human embryos for research.”
Stem cells are developed mainly from donated embryos. From a single embryo, millions of cells can be cultured to develop due to the unique nature of the cells, according to the National Institutes of Health.
In recent years, the field of stem cells has advanced greatly, according to experts, thanks in part to the lessening of restrictions and advancements in technology. Experiments involving stem cells are being done across the country to help a host of conditions, including Parkinson’s disease, multiple sclerosis, spinal cord injury and diabetes, among others.
Kevin McCormack, communications director at California Institute for Regenerative Medicine, said reintroducing a funding ban to stymie research would likely be more difficult than it was in the early 2000s when stem cell research was a new field.
“It would be like putting a genie back in the bottle,” said McCormack.
Pointing to one case at the University of Southern California, where a paralyzed man regained hand movement after an experimental stem cell therapy, McCormack said any measures that would halt funding or restrict stem cell research wholesale, “would be like going up to someone and say you can't have that treatment.”
McCormack did note that more states have provided stem cell funding, including California, which provides grants for the California Institute for Regenerative Medicine. While state funding could help, the NIH provides a huge amount of funding for U.S. medical research, spending approximately $32 billion on medical research annually.
Dr. Lorenz Studer, director of the Center for Stem Cell Biology at Memorial Sloan Kettering Cancer Center, said after decades of research, scientists are finally starting to see concrete signs that stem cells could become a common form of treatment for certain diseases.
“There has been so much investment to do basic research,” said Studer. “We want to move forward and see it's going to work.”
Studer’s lab has been working on treatments for Parkinson’s disease for decades and said he expects that next year experimental treatments for human patients will finally start.
His team has created billions of nerve cells designed to imitate the cells lost in Parkinson’s disease. The cells are derived from a single line of embryonic stem cells that are replicated again and again from a single embryo.
“The idea has been around for 20 or 30 years ... but we never had a good source of cells to do it,” he said. Researchers have seen promising results in animal studies with stem cell-based treatments, Studer said.
Federal Funding Is 'Essential'
Studer’s current funding comes from New York State, but he said federal funding has been “essential for this type of research” in the last 20 years.
In 2001, Bush signed an executive order that stopped all federal funding for embryonic stem cell research, except for a handful of cell lines that had already been cultivated from embryos.
As a result of these restrictions, researchers faced either giving up federal funding, creating siloed work environments to separate federal funds from other grants or working with cell lines that weren’t quite right for their area of study, according to Studer.
Studer himself said he had duplicates of lab equipment that had labels to denote if they were paid for by federal funds or other funds.
“What you had to do was label all vial dishes, so some would be for federal funding and some would be for non-federal funding,” said Studer. “It was obviously very cumbersome.”
Around the time the restrictions were lifted, Dr. Allen Spiegel, dean of the Albert Einstein College of Medicine and vice chair of the National Institutes of Health Stem Cell Task Force, told ABC News the years of restriction on embryonic stem cell research has been a major setback for U.S. researchers.
"In hearings [before senators] ... I stated that banning funding for research on human embryonic stem cells was like tying one hand behind the backs of stem cell investigators," Spiegel said in 2009. "Lifting the ban cannot eliminate the effect of years of delay, but harnessing the full power of NIH to review and fund scientifically meritorious research projects will accelerate progress toward the goal of helping people suffering from diabetes, neurologic diseases and many other conditions."
Studer said there is promise with a new line of stem cells called “induced pluripotent stem (iPS) cells.” These cells are “reprogrammed” adult cells, derived from skin or blood cells, that mimic embryonic stem cells.
In 2009, Pence cited these cells as a way to avoid using embryonic stem cells. “These altered cells are known as induced pluripotent stem (iPS) cells, and unlike embryonic stem cells, iPS cells do not require the destruction of human eggs or embryos,” Pence wrote in the essay. “These reprogrammed cells have equal or greater potential to heal unhealthy tissue or combat disease in human organs.”
However, the NIH reports "it is not known if iPSCs and embryonic stem cells differ in clinically significant ways."
“The process of making your skin or blood cells into iPS cells, it's a pretty crazy process. You have to put in four genes, and at the end, you get something similar,” Studer, who uses iPS cells in research, explained. “At the end, there's a concern that... it may not be completely safe” for clinical use. He noted that there is not as much evidence these iPS cells -- first discovered in 2007 -- are as safe to use in experimental treatments in humans as embryonic stem cells, which have been studied for decades.
Charo said the way researchers find out if these cells are effective “is by comparing them to what embryonic stem cells can do, that will be an important thing to keep in mind.”
Charo said in addition to access to funds for stem cell research, one area of concern is that research using fetal tissue will also be curtailed. Fetal tissue has been used since the 1920s by researchers to study a host of conditions, including vaccine efficacy, transplantation complications and other neurological disorders. In the 1950s, the NIH started to fund research that involved using fetal tissue.
Earlier this year, four states, including Indiana, where Pence is currently governor, passed legislation that banned the donation of fetal tissue for research, according to the Guttmacher Institute. The Indiana law signed by Pence also required abortion providers to cremate or dispose of the fetal tissue rather than give the tissue to medical researchers. The laws were passed after video emerged that incorrectly indicated abortion providers from Planned Parenthood were illegally selling fetal tissue for a profit.
“We already have ongoing clinical trials for things like serious neurological [diseases] like MS,” said Charo. “It's been so much more difficult to get this tissue ... because the atmosphere has gotten really chilling.”
This summer, the Indiana law was suspended by a judge a day before it was set to be enacted. It currently remains suspended.