Human stem cells are essential for the growth and maintenance of our organs, bones, and systems. They are also amazing tools of discovery for scientists at the Institute for Stem Cell and Regenerative Medicine and researchers around the world studying how to stop diseases. However, predatory businesses across the country are misusing the term stem cells to market unapproved, unproven, and unsafe procedures that are often expensive and largely ineffective. It’s important to understand what stem cell therapy really means.
Let’s start by creating two categories of stem cell therapies – approved (by the FDA) and unapproved. Whether a stem cell therapy is approved or unapproved has critical implications for the science, effectiveness, and safety of the procedure.
At this point in time only a few FDA-approved stem cell-based therapies are available. The most common such treatment is the blood stem cell transplant procedure in which blood stem cells are used to treat patients with blood cancers, like leukemia. In this procedure, harmful cancer cells are attacked with chemotherapy, then replaced with healthy stem cells that, hopefully, proliferate and grow healthy tissue. Like all FDA-approved treatments, the blood stem cell transplant procedure was the result of rigorous research and testing conducted over many years.
(In addition to blood stem cell transplants), the FDA lists a limited number of additional approved products on its website.)
More recently, hundreds of businesses around the country referring to themselves as clinics have begun marketing various versions of stem cell therapy that promise to help patients with serious conditions like Parkinson’s disease and more common ailments like joint pain. In reality, most of these types of stem cell therapy do not use stem cells at all. Rather, they remove tissues that presumably contains adult stem cells from one body part and inject those cells into another part of the body.
Furthermore, there is no proof that any stem cell therapy offered by stem cell clinics is effective or safe. Unlike FDA-approved procedures, which are subject to years of rigorous trials, unapproved treatments marketed directly to patients are developed and performed with little oversight. While stem cell clinics often tout testimonials from satisfied customers, there has never been a large-scale clinical trial to demonstrate that the perceived benefits of a stem cell therapy aren’t the result of a placebo effect. In recent years, the FDA has begun to expand regulations and enforcement of these clinics.
Thanks to decades of data, we know much more about the effectiveness of blood stem cell transplants. We also know they are not instant cures. While the procedure itself only lasts a few hours, recovery can take weeks. During this period, patients are monitored closely by physicians and nurses for side effects and for evidence of recovery.
There are side effects associated with approved and unapproved stem cell therapies. The possible side effects of blood stem cell transplants are detailed on the Cancer.org website. Patients considering an unapproved stem cell therapy should be aware that these procedures carry serious risks – and that these risks may not be managed by a qualified care team. Injecting even a person’s own tissue in a different body part has resulted in severe illness and, in some cases, blindness.
Therapies offered by stem cell clinics come with financial risk as well. Because these procedures are generally not covered by insurance, people seeking treatment are required to pay large out-of-pocket fees with no guarantee of improved health.
In their advertising, stem cell clinics promise unsubstantiated relief or even cures for everything from knee pain to Parkinson’s disease, often taking advantage of vulnerable individuals who may feel they have nowhere else to turn. In reality, there is no strong evidence to back up claims that any stem cell therapy works – let alone has lasting benefits.