Regenerative medicine and stem cells: Unmet expectations or genuine possibilities?
Ain't regenerative medicine the hotness, right? It's like the wild west of medicine, promising to revolutionize treatments with stem cells and biocompatible materials dancing center stage in this revolution. Plenty of groundbreaking advancements have been announced in labscapes and media outlets for years.
But here's the catch, the number of regenerative medicine treatments actually in medical use today? Slim to none. A panel of smart cookies published a report in The Lancet last week critiquing this lack of progress. In fact, according to Prof. Giulio Cossu and his pals from the Division of Cell and Matrix Biology & Regenerative Medicine at the University of Manchester, only a smidgen of groundbreaking research has made it to the masses, and some private clinics are getting rich off patients' desperation by hawking unproven therapies.
So, what gives? Why do so many regenerative medicine cure-alls fall flat? What will it take for society to capitalize on the immense potential this field holds?
What the Heck is Regenerative Medicine?
The commissioners say in their report that regenerative medicine "aims to replace or repair human cells, or regenerate tissue or organs to restore normal function." The emphasis on "normal function" sets this approach to medical treatments apart from many commonly used drugs, which generally just treat symptoms.
"Cell therapies and regenerative medicine, with their potential to drastically improve a patient's health, represent a fundamental shift in healthcare by focusing on addressing the underlying causes of disease by repairing, replacing, or regenerating damaged cells in the body," the authors explain.
Take diabetes, for example. If you got type 1 diabetes, you can't produce insulin. Instead, you have to give yourself daily insulin shots to keep your blood sugar levels stable. Regenerative medicine might solve this by regenerating the islets of Langerhans, allowing the body to make insulin again, rendering insulin shots a thing of the past.
While regenerative medicine-based diabetes treatment isn't available yet, there are some areas where this stuff is already in use.
Early Successes
Transfusing blood was the earliest form of cell therapy, and well, consider it common practice in most hospitals today. Next up was bone marrow transplants, giving patients with radiation injuries or blood cancers a chance to make new, healthy blood cells using donor bone marrow stem cells.
Cell therapy using a patient's own cells is also used in cases of severe burn and scald injuries. Here, skin cells are isolated from a small biopsy, grown, and then transplanted onto the burn wound to speed up healing.
But despite these successes, regenerative medicine treatments have yet to enter mainstream medicine in most areas. According to the report in The Lancet, there's potential to significantly reduce the burden of diseases such as stroke, heart disease, progressive neurological conditions, autoimmune diseases, and trauma. Plus, regenerative medicine therapies could greatly improve the quality of life for many patients with chronic diseases.
From Lab to Life
An army of scientists around the globe is churning out new regenerative medicine solutions to common diseases and injuries. The past year alone saw reporting on a chip technology that can swap one cell type for another, heal entire organs, a new method of spray-painting biomaterials onto damaged hearts using minimally invasive surgery, and a growth factor that could reverse osteoporosis.
So, why haven't we started seeing these new treatments in doctors' offices yet? Well, there are a few reasons. First, getting approval from regulatory bodies like the FDA is a time-consuming and costly process. Second, regenerative medicine treatments can be real pricey due to the need for special production facilities and highly-skilled staff. With healthcare budgets stretched thin in many places, high costs can be a barrier to implementing these therapies.
The Big Question: Are Patients Getting Ripped Off?
In August, FDA commissioner Dr. Scott Gottlieb issued a statement saying, "[...] dishonest actors exploit the sincere hopes of patients facing bad illnesses." As part of a crackdown on these shady operators, the FDA issued a warning to a stem cell clinic in Florida for marketing unapproved stem cell products.
In this particular case, the clinic was charging patients a hefty sum for stem cells from fat, which they injected either intravenously or directly into the spinal cord to treat a variety of conditions. Despite a complete lack of scientific evidence suggesting this treatment works, the clinic failed to adhere to guidelines meant to prevent microbial contamination, putting patients at risk.
So, what's a patient to do when they're desperate and being taken advantage of? Tight regulation and busting those operating without a license are key to keeping patients safe.
The Future Ain't Written Yet
While scientific advances in stem cell and regenerative medicine research are touted as breakthroughs, a study breakthrough doesn't mean a new therapy has arrived yet. Conflicts between public expectations and the slow speed at which new treatments can be developed are common. However, regenerative medicine does have a track record of success in a small number of diseases.
The big question is, will regenerative medicine play a significant role in global health in the immediate future? Prof. Giulio Cossu isn't convinced. He did, however, emphasize that regenerative medicine holds immense potential. From the first blood transfusion to bone marrow transplantation, cloning, embryonic stem cells, and induced pluripotent stem cells, to genome editing and organoids – the field is bursting with promise.
So, the dreams remain the same: take cells, biomaterials, or molecules, and put them into a patient to treat their disease or injury. To move regenerative medicine into the mainstream, better science, better regulation, innovative manufacturing methods that make treatments affordable, and a way to demonstrate their benefits for patients and society are essential.
Balancing risks, costs, and potential benefits is the challenge. As the commissioners conclude, "How we proceed in this new global terrain might be the biggest challenge of all for researchers, doctors, patients, relatives, regulators, and society as a whole."
- Regenerative medicine aims to replace or repair damaged cells, regenerate tissue or organs, and restore normal function, focusing on the underlying causes of diseases.
- While some regenerative medicine treatments, such as blood transfusions and bone marrow transplants, are already in use, the field has yet to make significant inroads into mainstream medicine for most diseases.
- Despite promising advancements in stem cell and regenerative medicine research, the lack of stringent regulation and high costs associated with these treatments can pose risks for patients seeking unproven therapies.
- The ultimate success of regenerative medicine lies in better science, stricter regulation, cost-effective manufacturing methods, and demonstrating the benefits for patients and society, as society navigates the challenges in balancing risks, costs, and potential benefits.
