Health feature: Regenerative therapies, part 3: Future of medicine
July 19, 2016
Editor's note: This is the third and final article in a series about regenerative therapies. The intention of this series is to inform medical consumers about current and future choices when looking at potentially undergoing a stem cell treatment and to provide a coherent explanation of what we know and are trying to understand about this new wave of medicine.
The consensus in the medical community is that regenerative medicine is the next big advancement; however, questions remain about some of the more basic parts of the new technology. Researchers are currently hard at work to create more foundational studies to support the use of biologics in patients and to progress stem cell treatments so that in the near future, we will be able to treat a wide range of ailments, chronic diseases and injuries with stem cell therapies.
Pinpointing the unknowns
Physicians have seen good results from the conservative use of biologics that is currently allowed in a clinical setting. However, most agree that more needs to be done to create a larger body of research to progress treatments involving stem cells.
Dr. Robert LaPrade, of The Steadman Clinic, explained that although researchers are optimistic that biologics are the next big advancement in medicine, there needs to be a coming together of physicians to establish more basic scientific foundations in order to use the technology to its full capability.
"We went from open knee surgeries to arthroscopies, and it totally changed what we do, and I think the next big advance is biologics," he said, "But, the issue with biologics is that right now, we jumped into treating people instead of looking at the basics in research, so one of the things we need to do is take a step back and figure out the basics.
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"For example, PRP (platelet-rich plasma) has lots of different growth factors. Some of those are good, and some of those are bad, so in certain patients, you might have more good elements and some patients you might have more biologic factors that actually slow down healing, and we don't know what we're dealing with in some of these people."
Additionally, the high variance of stem cells and regenerative tissues between individuals, and even within a single individual, often make it difficult to pinpoint the concentration of regenerative tissues that patients are getting during treatments, which can further blur some of the more basic data needed to advance treatments.
"We're trying to figure out ways to quantify what we're injecting," said Dr. Peter Millett of The Steadman Clinic. "The problem with our current system is that for a PRP injection, for example, one person's blood might be different than another person's blood, and their tissues are always changing, so there might be a difference between what you're drawing from different individuals, and even from the same person — you might see differences between drawing someone's bone marrow in the morning versus at night."
To combat such problems, many in the field are calling upon researchers and clinicians to work more cohesively in order to advance regenerative treatments. Dr. David Karli, also of The Steadman Clinic, explained that much of the problem with the current set of research is that the variables present in regenerative treatments make it hard to observe a baseline data trend from which to draw more concrete conclusions.
Karli is currently heading a Vail-based company called Grey Ledge, which works to process samples for injection that are standardized in their amount of regenerative tissues and allows researchers the ability to compare bigger and more relevant data samples.
"The key with having a big group of people is that they have to be using the same products. If each individual entity is doing it differently, you can't really collate those data sets," he said. "I always liken it to a cardiac medication; if you had high blood pressure and you wanted to research a cardiac medication and you had five different doses and you didn't know which dose you gave, how could you asses your outcomes?
"We've been able to look on the cellular level at what our dosages contain and then look at what trends were present in patients who did well and didn't do as well, so we can then tweak the model to improve the likelihood that someone will have a positive outcome."
Karli's goal is to not only standardize the injections that are being used in the Vail area but to take the platform to a national, and even global, level in order to start seeing bigger, more comprehensive data sets that can hopefully be used in other areas of medicine to advance regenerative applications.
Others at The Steadman Clinic, including LaPrade and Dr. Thos Evans, have been working on research to determine more foundational elements of stem cell treatments in order to establish more of a baseline on the data. LaPrade has been working in conjunction with Colorado State University to examine some of the more basic factors of platelet-rich plasma, while Evans has been looking at the makeup of the concentrated injections to determine what factors are more beneficial in healing than others.
The goal is that some of the information they are able to gather will help put out better evidence for regenerative treatments in order for regulators to have better data to create restrictions accordingly.
Need for balance
The Food & Drug Administration currently oversees regulations regarding stem cell treatments, which cover the use of regenerative medicine in both a clinical and research setting. Currently, the restrictions in both a lab and clinical setting remain very strict, which can make it difficult to follow leads in research in a way that progresses treatments.
"Currently, the FDA only allows for minimal manipulation of the tissues," Millett said. "The tissues can pretty much just be centrifuged — they can't be stored for future use, we can't add medications or growth factors to the injections, and we can't put it through a processor to select out stem cells or other regenerative proteins; that really limits what we can do presently."
However, with more researchers looking to establish better data to support some of the theories that many are thinking stem cell treatments will someday be capable of, there remains hope that a broader spectrum of treatments will be available for the public over the course of the next decade.
Millett went on to say that with what researchers are starting to see in labs around the world, and within the small niche that has shown great promise in a clinical setting, the possibilities for using regenerative treatments would change the way we treat a host of different bodily problems.
"In the near future, we believe we will be able to manipulate the cells and proteins to make them more effective and 'tissue specific,'" he said. "For example, we will be able to make cartilage-specific or tendon-specific cocktails that will enhance and accelerate healing of the specific tissue that is damaged or in need of repair."
And while the first and foremost goal of the FDA and physicians is to keep people safe, there remains a sentiment that with all that is already known from early stem cell data and the conservative use of treatments in a clinical setting, more must be done in order to advance research.
"They (the FDA) have a good process to make sure that we don't have a problem," LaPrade said. "But most of us feel like we need to accelerate the process, otherwise our country is going to fall behind, and we've always been innovators in medicine, but in this case, we're falling a little bit behind because some countries are letting people fast track these studies."
Fast tracking all studies isn't advisable, either, as medical tourism in this regard has led some to have malignant outcomes because of the lax regulations that exist in other countries. There needs to be a balance between pushing forward studies that are showing promise and keeping patients safe in the process.
Regenerative medicine is the next big thing in medicine, and many of the future applications of biologics have yet to even be discovered in this regard. The hope and the goal is that with further advancement of research, the establishment of coherent baseline data and physicians seeing wide-ranging benefits from stem cell treatments, this next wave of medicine will be one that is standard practice, covered by insurance and safe for all.