F112 Stem cells - How is regenerative medicine disrupting the MedTech industry (Frank Barry)
The idea behind regenerative medicine is to enable medicine to use human cells as therapies. This means that instead of using artificial joints and other implants we currently use for healing, we could use cells that would regenerate our own tissues.
According to World Economic Forum, the current market for stem cell therapies is growing at 36% per year and will rapidly expand when a breakthrough treatment for non-communicable disease or a lifestyle factor occurs.
“The discipline of regenerative medicine is on the point of exploding. It's a whole new paradigm of medical treatment. It involves cell therapy and gene therapy. It's disruptive because it will put out of business many of the more traditional medical technologies. And I think we'll see an enormous economic growth associated with this field in the next, say 10 years,” says Prof. Frank Barry is Senior Scientist at the UHN Arthritis Programme at the Krembil Research Institute and Professor of Cellular Therapy at the Regenerative Medicine Institute (REMEDI), National University of Ireland Galway. He also plays an important part in the ARTE Interreg project which is dedicated to introducing novel cell-therapies based on mesenchymal stem-cells into orthopaedic hospitals in Slovenia & Italy.
What is stem cell therapy used for?
The research space around stem cells is vibrant. However, apart from the field of hematology where stem cell transplantation is used for the treatment of leukemia, lymphoma, and myeloma, other treatments are not yet routine or necessarily approved. Unfortunately, however, because of the potential and promise of regenerative medicine, over 700 clinics in the US offer expensive stem cell therapy claiming it can heal anything from knee pain, asthma, congestive heart failure, Parkinson’s disease, and more. These claims are not scientifically proven.
Sometimes patients run out of options. Their condition is so serious that they would give anything just to get a chance at survival or quality of life improvement. This is also why stem cell clinics have clients that are willing to pay a lot to see a glimpse of improvement. It can cost them much more than just money. In a comprehensive article, the BBC reported that at least 17 patients were hospitalised in 2019 in the US after umbilical cord blood injections. The Centers for Disease Control confirmed a series of bacterial infections. Most of these patients were treated at orthopedic, chiropractor, and pain clinics and were given injections into their spines, knees, and shoulders.
“If you're very sick, and there are no treatments available, you're essentially going to try anything. If a family member is suffering from a condition and there's no treatment available, you will also want to try anything. So patients and their families, because of the desperation that they feel, they literally go to the four corners of the world to look for treatments that they think might be effective. And that's very understandable. But to take a treatment from an unregulated clinic, where there isn't sufficient evidence to support its use is a very, very dangerous thing to do. Plus, some of these clinics charge phenomenal amounts of money. Patients and their families end up losing huge amounts of money for treatments, which at the very best, have no effect and at worst significant negative side effects,” says prof. dr. Barry, adding that in the last two year in the US and Canada, the Food and Drug Administration in the US and Health Canada In Canada, have both clamped down very strongly on these clinics offering stem cell treatments, and many of them very many of them have closed.
Dr. Frank Barry.
Stem cell types
There are three types of stem cells: embryonic, umbilical cord, and adult stem cells. Embryonic stem cells are “the most powerful” because of the pluripotency. Embryonic stem cells candevelop to all of the cell types that make up the human body. Umbilical cord stem cells are younger adult stem cells. And then there is adult, also called somatic stem cells are found in organs or tissues. These cells can self-renew and yield the differentiated cell types comprising that organ or tissue (multipotency). Probably the most known is the bone marrow tissue, adult stem cells are derived from the adipose tissue - the fat, and there are other tissue sources.
Mesenchymal stromal cells (MSCs) have firmly occupied the attention of orthopedic clinicians and scientists for most of the last 25 years. We are, however, still not on the finish line where stem cell therapy would be routinely used for say knee replacement.
“There have been a number of clinical trials that have shown very positive results. The results so far suggest that this treatment is effective in either slowing down or reversing the progression of arthritic disease. The problem is that the clinical trials are still not big enough to have the needed statistical significance for widespread use. As with any new medicine, or any new drug, you have to do large scale phase three clinical trials. We're not yet at that point,” points of prof. Barry. As he further explains, the reason lies in the fact that the research field is driven by academia that has to raise all the funding, all the research grants to pay for all the hospital costs for the trials to happen.
The disruptive factor of stem cell therapy
“Osteoarthritis is the most common form of arthritis, it's the most debilitating musculoskeletal disease and has an enormous impact on patients, on their families, on their quality of life, on their income,” emphasizes prof. dr. Barry.
Osteoarthritis is also a huge burden on health care systems because a lot of procedures and hospital resources are required to treat patients with the arthritic disease. “There isn't any medicine, any therapeutic intervention of any kind that would reverse this disease. The only thing that you can do, the treatment you can avail of is joint replacement surgery, which is quite a serious operation. So there's a very, very strong compelling need for a different approach simply on the basis of health, economics and quality of life. We believe that stem cell treatment is a very attractive option,” says prof. dr. Barry. This also means that if stem cell therapies would become mainstream, they would disrupt the industry of joint replacement implants and surgery.
“It's important to bear in mind that total hip replacement surgery or total knee replacement, or other types of joint replacement surgery are incredibly successful. The surgical approaches are much simpler and quicker than they used to be. They are sometimes these are done in an almost outpatient basis with a day or two long hospital stay. These procedures are also very successful, they're life changing for the patients because they go almost immediately from a situation of chronic pain and loss of function to a situation where the pain is gone, and their joints work much more or much improved. But nonetheless, these surgeries generally happen in the context of chronic disease. So in other words, the patients have had years and years of pain and poor joint function before they have the joint replacement surgery. Whereas what we're doing will have an impact much earlier on. So they won't have to experience those years of chronic pain that they that they currently do,” explains dr. Barry.
Cell therapies are a very broad field, with stem cells just a segment of it. There are a lot of futuristic ideas as to where cell therapy could go. In 2019 Israeli researchers presented the first 3D-printed heart with cells and blood vessels.
Someday in the future, we will hopefully see 3D printed tissues and organs.
Tune in for the full discussion.
Some questions addressed:
“Someday, stem cells will be enlisted to help repair or replace damaged tissues and organs. They will rescue us from diseases for which drugs can only treat the symptoms. But they may have another role in our lives, one that is not so beneficial. They may in fact be the source of some, and possibly most cancers.” - this is the introductory statement about stem cells on the Harvard Stem Cell Institute’s website. For starters: how good or how bad are stem cells? https://hsci.harvard.edu/stem-cells-and-cancer
How big is the field of stem cell regenerative medicine research inside the cell therapy space?
Can you briefly outline research areas of each cell type? Which different conditions is each addressing? I assume the field of embryonic stem cells is the smallest one because of ethical reasons?
Mesenchymal stromal cells (MSCs) have firmly occupied the attention of orthopedic clinicians and scientists for most of the last 25 years. We are, however, still not on the finish line where stem cell therapy would be routinely used for say knee replacement. What is the state of research at the moment? What are atm still the key barriers? The unknowns that are slowing down research?
If stem cells become a standard of practice, what will it mean for the medical device industry? Surgeries for knee replacements, implants etc? Is it possible that stem cell treatment will only be available to rare that will be able to afford it?
How do you see the collaboration with the industry in the field? Are they driving progress or is the industry the “necessary evil”?
Is there enough funding for this kind of research? How much do initiatives like ARTE contribute to progress? Are government-funded programs bringing progress or are they just aiding partial questions without having a lasting impact?
How has technology shaped stem cell research?
For a while, it was very fashionable to save umbilical cord cells to protect the future of our children. What happened with that trend…?
There is a lot of misleading information in the public around stem cells. How can consumers rely on the providers offering stem cell therapies?
Based on your research, how far are we still from stem cell therapies being routinely used?