The Globe and Mail – For years, Lauralyn McIntyre has witnessed first-hand how quickly and brutally septic shock can throw a patient’s life into jeopardy.
“It can cause pretty much every organ in your body to fail,” said the critical-care physician and senior scientist with the Ottawa Hospital Research Institute.
Septic shock arises when the body’s immune system goes overboard in response to an infection and begins attacking its own tissues. In Canada, it accounts for 100,000 admissions to intensive care annually, with about one-third of cases ending in death. Many of those who survive experience lifelong damage to their health.
Now Dr. McIntyre is hoping a experimental stem cell treatment will allow her to gain the upper hand on a relentless killer. The treatment involves an emergency infusion of mesenchymal stem cells – cells generated from donors’ bone marrow – in order to calm down the body’s defenses. Based on data gleaned from animal tests, the stem cells “seem to restore the immune system back to a normal state,” Dr. McIntyre said.
Last week, Dr. McIntyre won $1-million in federal funding through the Canadian Stem Cell Network to start a phase II clinical trial that will test whether the treatment is effective in humans. The award is part of a $9-million boost from Ottawa aimed at keeping Canadian researchers in the global race to develop new stem cell therapies.
The amount is modest relative to the hundreds of millions Canada has already allocated toward stem cell research and the nearly $1.5-billion that the U.S. National Institutes of Health will spend on the field this year alone.
Yet, Ottawa’s latest show of support comes just as scientists in the United States are wondering what a Donald Trump presidency will mean for those areas of stem cell research that have previously been opposed by social conservatives, including Vice-President-elect Mike Pence.
Stem cells play a crucial role in human biology because they generate the more specialized cell types that the body needs to function. Human embryonic stem cells, which are derived from donated, unused embryos from in vitro fertilization clinics, are the most versatile of all. The embryos, only days old, are microscopic clumps of cells at that point. But on the premise that they can be used to create human beings, their destruction to generate cell lines for research has been opposed by U.S. anti-abortion advocates.
In 2001, U.S. president George W. Bush limited federal funding for research involving human embryonic stem cells to a handful of existing cell lines. Scientists working with the cells as a potential route to treating degenerative disease found themselves embroiled in a highly charged political and ethical debate. Some of the arguments centred on whether stem cells derived from adult tissue could be used as alternatives to the embryonic cells.
Within weeks of taking office in 2009, President Barack Obama signed an executive order lifting the Bush-era restrictions. Mike Pence, then a Republican congressman, wrote an op-ed criticizing the president for “trampling the wishes of millions of Americans who cherish the right to life as a gift of God.”
Tom Price, a Georgia congressman and osteopath whom Mr. Trump named on Tuesday as his choice to lead the Department of Health and Human service, which oversees National Institutes of Health, voiced similar objections.
Seven and a half years later, the field has advanced rapidly and NIH funding now includes about $195-million a year toward human embryonic stem cell research. Unprotected by legislation, the funding could be halted with the stroke of a pen should Mr. Trump choose to overturn Mr. Obama’s order once he takes office – a possibility that has researchers in the United States and beyond collectively holding their breath.
“To be frank, so little was said about science during the campaign that no one knows what’s going to happen,” said Peter Zandstra, a University of Toronto researcher who directs a stem cell research initiative that received a $114-million federal grant from the Harper government in 2015.
Alta Charo, a professor of law and bioethics at the University of Wisconsin–Madison, closely followed the legal battle that ensued after the Obama executive order. She points out that new funding restrictions could prove to be immensely complicated for university labs that currently work with different kinds of stem cells. Human embryonic stem cell research would have to be separated out from others to demonstrate no federal dollars were involved. Even the shared cost of keeping the lights on – something that the Bush restrictions did not include – could, in theory, become an issue.
Prof. Charo also noted that research with fetal tissue, which Mr. Pence worked to prevent as governor of Indiana, was similarly at risk, even though the growth of such research has not led to an increase in abortions, as opponents of such research argued.
“Despite that fact, and despite the fact that these things are manifestly needed for health research, there is a willingness to sacrifice patients over what is really a symbolic gesture,” she said.
Michael Werner, who heads the Washington-based Alliance for Regenerative Medicine, an advocacy group that supports stem cell research, said that, for the moment, “people are taking a wait-and-see approach” in the absence of any indication of where Mr. Trump’s opinions may lie.
“Is this the kind of issue that [Republicans] will want to work on right out of the gate? It’s hard to know,” he said.
The uncertainty raises the question of whether Canada may benefit from a brain drain if researchers in the stem cell field who are in the United States now or would otherwise have moved there decide to come to Canada instead.
However, constrained funding and a lack of private-sector investment required to bring new therapies to market make Canada a less attractive environment for researchers. And in the long run, a slowing of progress in American stem cell research would have negative consequences across the field, said Canadian Stem Cell Network president Michael Rudnicki.
“All of us benefit around the world when science in the U.S. is strong,” he said.