The Side Of Stem Cell Therapy Nobody Tells You About

30/11/2016

Providing you don’t live under a rock, there’s no doubt you’ll have heard all the hype around stem cell therapy, especially with recent headlines like, “Cancer cure hope in 3D stem cell research”, and, ”Stem cell therapy gives hope to MS patients”, splashing national newspapers and popular media websites.

The number of clinical trials around the world that involve stem cell therapy is skyrocketing. Every day a piece appears in the news about a new trial or study that could lead to a cure for a certain disease or illness.

As the coverage of stem cell research expands, so does public interest and the demand for gaining a piece of the action and achieving the seemingly miraculous.

With hundreds of trials and clinics providing access to stem cell treatment, tens of thousands of people are already benefitting from treatment. Although the market for treatments is still young, it’s expected to be worth over £117.9 billion ($170 billion) by 2020.

The Race Is On For Stem Cell Treatments

So why wouldn’t you want stem cell therapy? High-profile athletes and sports stars are getting it in their droves, with big names like Christiano Ronaldo, Rafael Nadal, and Tiger Woods opting for stem cell treatment to ensure a speedy return to their sports.

Decades of research and rigorous clinical trials indicate stem cell therapy can treat people with lung disorders, spinal cord injuries, autoimmune disease, liver disease, degenerative joint disease, and neurological diseases such as Parkinson’s and Alzheimer’s.

The problem is the weighty promise and optimism for stem cell treatments is being capitalised on and exploited by a community of second-rate treatment providers. Such companies and clinics are not for the advancement of medicine, but for preying on desperate patients and profiting on their hope of improving their health.

Treatments are being offered everywhere from Russia and China to Europe and, in particular, the US. One could argue that the majority of the services on offer are credible, but in an unregulated market with at least 350 companies in the US alone marketing stem cell treatments, some of them inevitably fail to make the grade.

But if stem cell therapy is so great, what’s all the fuss about treatments being unregulated? Surely not having a stamp and licence from the drug administration authority doesn’t dismiss years of evidence-backed success?

A Worrying Account From A ‘Stem Cell Tourist’

“You have these businesses promoting anti-aging, longevity, restoration of youth, that you can ‘come to our place and feel younger, look more vibrant.’ There’s the sexual enhancement dimension,” —Leigh Turner, professor of bioethics at the University of Minnesota and co-author of the study

The disturbing story of Jim Gass, who was attempting to recover from a stroke suffered in 2009, was recently reported in an article by The New York Times.

Mr. Gass had read about stem cell therapy in the news and heard stories such as that of professional golfer John Brodie, who after also suffering a stroke went for stem cell therapy in Russia and returned to playing golf again.

Despite discouragement from his doctors and sister-in-law, Mr. Gass sought out a program on offer at a clinic in Mexico. The treatment he received lead to improvements in his ability to walk, but they were short lived. Mr. Gass spent the next few years travelling the world, visiting other clinics in Mexico, China, and Argentina, and spending nearly $300,000 on travel and stem cell treatments.

“I felt pain when I would lie down, like I was lying on a tumour… I started to lose my ability to walk and I fell down a lot.” —Jim Gass

After feeling discomfort in his lower back and an increase in his symptoms, Mr. Gass visited doctors in the US who were shocked to discover a huge mass of someone else’s cells growing aggressively in his lower spine.

Mr. Gass is an unfortunate case but he’s not the only one seeking a cure through stem cell therapy. Many patients are being deceived by clinics, at times paying up to £30,000 for one single stem cell injection.

It’s important to point out that not all unregulated clinics are ‘snake oil salesmen’. Many are highly reputable and actively involved in stem cell research. Most of the time it’s clear to see which clinics are the charlatans of the industry and which aren’t, and sometimes hope and emotion can get in the way and cloud judgement – particularly when in ill health and willing to do anything to get better.

Avoiding The Charlatans Of The Stem Cell Market

Much like in other industries that offer medical services outside of the public healthcare system, e.g. plastic surgery, there are certain low-grade clinics which enrol in unethical behaviour and cunning marketing tactics in order to try and boost their revenue.

With a website acting as the shopfront to international customers, some clinics use fake patient reviews to build their credibility and influence prospective customers. In the case of Mr. Gass, his sister-in-law discovered some of the testimonials on the sites of the clinics he went to, were from people with financial interests in the companies.

Other commonalities between poor-quality clinics include having no experienced stem cell researchers in their team and no record of previous research trials — not even phase one or phase two trials.

With more and more of these type of clinics popping up, the reputation of the stem cell industry is taking a hit, and focus is being drawn away from the clinics which are — while also being unregulated — providing legitimate, safe, and effective treatments.

The word ‘unregulated’ can often set off the warning signals for many. But quite frankly, the only difference between high-quality clinics being unregulated and regulated is not efficacy and safety, but rather the huge sums of investment and years of trials it takes to obtain certification.

Unlike conventional therapies like drugs, trials of stem cell treatments are difficult to replicate and thus expensive to conduct. And as stem cell therapy is a ‘biological treatment’ rather than a pharmaceutical agent, there are a several more loops to jump through in order to meet these standards — which of course takes more resources and money.

As the researchers and scientists pursuing stem cell treatments are not big pharmaceutical giants but modest clinics and research labs, this lack of funding and resources to work through regulation processes is a major barrier, and slows down the progression of stem cell treatments.

Fortunately, drug regulation authorities are catching up to the fact, with organisations such as the FDA currently retrofitting an alternative drug pathway for biological treatments.

The Journey Toward Regulated Stem Cell Treatments

Stem cell therapy is not a miracle cure. The reality is there’s a growing pile of strong empirical evidence on the effectiveness of stem cell therapy in relation to current treatments. But in the current landscape, with no standardised regulation, not all services offered by clinics are going to be equal. Therefore, clinics which use unbacked statements and unfounded results, claiming to provide the ‘cure to all your woes’, should be instantly discarded.

The industry is still in its very early stages. The only clinics and providers that fully understand and can effectively deliver treatments offer all the right signals — they’re actively involved in clinical trials, display results from research and previous patients, have reputed researchers in their team, and have an abundance of patient reviews from independent sources.

In several months in the US — where a concentration of clinics offering stem cell treatments has accrued — the FDA will have a public hearing on the regulation of stem cell treatments. Draft guidelines are available to read now and the FDA believe this will be the start of the crackdown of charlatan clinics, and potentially the start of a rigorous approval process for being able to offer stem cell treatments.

Switching up the regulation process and creating a bespoke, tailored approval process for biological treatments is what the industry needs. This way it can move forward and protect patients from poor-quality services. But until then, if you approach stem cell therapy providers with due diligence, follow the advice we’ve provided, and make sure to do your homework, then you are sure to experience the incredible effects of stem cell therapy.