“J.A.R.V.I.S. in Culture” from the Stem Cell Networks’ 2019 Cells I See art contest (Photo by Malvin Jefri)
Just a few months ago, anyone Googling the phrase stem cell transplant would have been taken to private clinic sites around the world offering so-called “cures” for conditions ranging from multiple sclerosis to spinal cord injuries to aging. Seductive ads promised to isolate stem cells from one’s own bone marrow or blood, or extract these stem cells from donated umbilical cords or human embryos, and reinject them into the body to fight disease or promote healing –for up to $15,000 USD per treatment. Today, Google has placed active controls on those ads, and one Canadian public policy researcher who studies the legal and policy issues of emerging medicine couldn’t be happier.
“Many of the sites that promote stem cell-based interventions deal with procedures that haven’t been proven to be safe or effective, yet they create an unrealistic expectation of readiness of the science, offering false hope to patients and their families,” says Amy Zarzeczny, a University of Alberta-trained lawyer, graduate of the London School of Economics, and associate professor at the University of Regina’s Johnson Shoyama Graduate School of Public Policy.
Much of Zarzeczny’s research focuses on addressing policy challenges associated with emerging biotechnology, unproven and experimental medical interventions, and medical tourism. She says there’s a necessary balance between encouraging new technology and ensuring advancements are supported by rigorous and responsible science.
There are private, for-profit clinics operating around the world that are selling stem cell-based treatments for an array of issues,” says Zarzeczny, who routinely collaborates with international lawyers, political scientists, bio-ethicists, clinicians, and front-line physicians. “But when these treatments aren’t supported by years of rigorous research and clinical trials that show they are safe and effective, it’s incredibly concerning.”
“There are reports of patients suffering serious harm following unproven stem-cell treatments,” she adds. “The financial cost of these treatments can also be a burden, leaving some patients to turn to crowd-funding to help them raise the necessary funds.”
Zarzeczny says medical tourism isn’t new, nor is people’s interest in pursuing medical treatments that fall outside the standard of care, but social media, and the internet in general, have made these options more accessible.
“While there are potential benefits to these developments, there are also challenges.”
Uncertainty regarding the quality of information is a key issue.
“There are products and services advertised with claims that are false or misleading, especially about the safety and likely effectiveness of the treatment. Sifting fact from fiction is not easy in a world where hype and half-truths dominate many headlines, and where people already have difficulty discerning what is and is not fake news.”
Zarzeczny says these direct-to-consumer markets for stem cells can be dangerous, and raise a number of concerns.
THE PROMISE OF STEM CELLS
Simply put, stem cells are unique human cells with the ability to self-renew and differentiate into numerous different types of cells in our bodies. The ability of a stem cell to divide and create new stem cells is akin to a single-celled zygote, created from a sperm and egg, which divides and doubles rapidly (one cell becomes two, then four, then eight, and so on). That zygote ultimately grows into a human being. Stem cells similarly have the ability to divide and differentiate to become specialized cells in our body, which gives them the ability to renew damaged tissues.
Current therapies already make use of this regeneration potential. In bone marrow transplants, a patient's existing white blood cells and bone marrow are destroyed using chemotherapy and radiation, then a sample of bone marrow containing new stem cells from a healthy, matched donor is injected into the patient. The transplanted stem cells populate the recipient's bone marrow and begin producing new, healthy blood cells.
Other exciting therapies are currently in early-stage research or fully funded clinical trials. Transplanted stem cells are being injected into damaged body parts and directed to grow and repair those tissues. This active field of biomedical research is looking at using stem cells to treat everything from spinal cord injuries to multiple sclerosis. But the science is complex. For a stem cell therapy to be successful, the appropriate type of stem cell must be chosen, and the stem cells must be matched to the recipient so that they aren’t destroyed by the immune system. There needs to be a system for effective delivery of the stem cells to the desired location in the body, and there needs to be a system to "switch on" and control the differentiation of stem cells to ensure they develop into the desired tissue type, and not into other forms such as tumours.
STEM CELL TRANSPLANT
Canada just happens to be a world leader in stem cell research. It has taken decades of work and untold hundreds of millions of dollars being put into research and clinical trials to come to the point where hope is on the horizon. And yet, there is a growing proliferation of companies that are promising similar or further advancements, or even miracle cures, with limited to no evidence to back up their claims. This absolutely appals Jennifer Molson from Ottawa, who was one of the first patients in Canada to undergo a stem cell transplant at the Ottawa Hospital Research Institute (OHRI) in 2002 for her early aggressive multiple sclerosis – a rare form of MS affecting only three per cent of the population.
“I got sick very quickly in my early 20s and couldn’t even shower or go to the bathroom by myself,” she recalls. “Luckily, I was in the right place at the right time and became one of 24 patients to undergo the first clinical trial for a stem cell transplant. The procedure was extensive, time consuming, and extremely risky, but at that point I was willing to risk death if it meant I might get better.”
In May of 2002, Molson was given chemo to wipe out her immune system. Her white blood cells and stem cells were then immobilized and essentially “cleaned up” by removing traces of MS–in essence, she grew a whole new immune system–before these cells were reinjected into her body. Two months later, she had her transplant. “A machine cycled my blood for seven hours through a port in my chest. I then threw up for an entire year. My immune system was compromised and I was like a newborn baby, having to be revaccinated for polio and childhood illnesses,” Molson explains. “I was told there was a chance I would die, and one of the patients in our trial did die. It was scary. Even today, I have to have regular checkups and take regular medical precautions, but it’s safe to say that I have no more serious MS symptoms.”
Molson says MS treatments have advanced significantly today, and that not everyone is a candidate for the type of stem cell transplant she received.
“Why use a nuclear bomb to treat an illness when less invasive treatments exist?”
Molson is so knowledgeable about such transplants that she is now a patient advocate and spokesperson for the Stem Cell Network of Canada, the national not-for-profit that supports stem cell and regenerative medicine research and training at OHRI.
While Molson empathizes with others who are sick and tired of being saddled with crippling illness, she says resorting to companies promising miracle cures is not the answer. “They’re hope-mongering, plain and simple,” she says. “There’s no way you can cram what I went through in two years–-and what I’m still going through today, 18 years later–-and accomplish the same thing in a week-long procedure. It’s impossible. You can’t skip all of the important steps and expect the same result. Yet companies are promising just that. Which is why the work that Amy Zarzeczny and others are doing to help change legal loopholes is so important.”
STEM CELL RESEARCH
Dr. Michael Rudnicki, who heads up the Stem Cell Network as its scientific director and is the CEO at OHRI, agrees. He lauds the incredible work that Zarzeczny and her team of collaborators are doing across Canada. “These foreign clinics are exploiting hope, and are in violation of the law. They’re putting ads in the paper offering quick-fix cures in big cities across the border like Buffalo, taking your $15,000 USD, and bussing you down to their clinics, reinjecting your blood, and promising that your Parkinson’s or MS will be cured, with no clinical trials, no medical results, and no follow-up. People are remortgaging their homes and going bankrupt chasing an elusive dream.”
Rudnicki says, at best, what is being injected back into the blood is causing the immune system to react, resulting in a temporary relief of pain. “But you are not regenerating tissue with injected stem cells – not in a week-long medical tourism getaway. Cures like stem cell transplants require years of research, hard data, clinical trials, and expert medical follow-up often lasting years following a procedure.”
POLICY PROTECTS PATIENTS
Zarzeczny is passionate, persuasive, and relentless in her desire to bring about change. She and her peers across Canada are making strides in protecting the sick and vulnerable by helping to inform and strengthen policy responses to this complex and often controversial arena.
Back in her College Avenue Campus office in Regina, Zarzeczny gets off the phone with an Edmonton colleague and makes a note to review his latest report. “I’m pretty fortunate to be here at the Public Policy school. It’s an interdisciplinary faculty with a strong focus on policy and public administration, which means many opportunities to liaise with decision makers at local, provincial, and national levels. I also have a wonderful group of collaborators across the country, and internationally.”
Recently, Zarzeczny published a study with scholars from Australia and Scotland looking at people’s information needs when it comes to stem cell research and treatment options.
“We know a better job needs to be done in educating the public so they get the entire story. We can’t have people making life-altering decisions based on some internet hype. That’s why this work is so important – because the science is evolving quickly and has real potential to improve treatment options for many people. But, as with anything, people need to know the risks.”
Zarzeczny says deepening our understanding through this type of policy research will help ensure that people interested in pursuing stem cell-based interventions have access to supports and to the accurate information they need to inform their decisions.
“Stem cell research is an exciting field, and we want to support the people doing innovative and responsible research. We can do that by developing and enforcing policy that minimizes risks to patients,” she says.
That starts with providing people with the facts about stem cell treatment options and calling out those internet ads for the false hope they are offering, and the harm they may be causing.
“Not everything you read on the internet is true,” she says. “People need to tread cautiously and have an open and honest discussion with their physician – not Dr. Google. I understand the desperation of some people to get well, but sometimes the physical, emotional, and financial costs of pursuing these so-called miracle cures can be considerable.”