Last week, the U.S. Food and Drug Administration (FDA) won a major ruling that seems to reflect the agency’s growing authority to regulate the stem cell industry. In light of this news, there is growing curiosity about stem cells and their potential to help or harm patients. Taking a moment to understand what stem cell therapy is and how it’s made available to consumers can help avoid the type of confusion that leads to successful stem cell therapy scams.
What are stem cells?
Stem cells are building blocks of the body. These cells often divide into daughter cells that differentiate into cells such as tendon, cartilage or bone cells and take on specific bodily functions. Otherwise, these daughter cells become new stem cells. When used for science and medicine, stem cells may come from a host of different sources.
Embryonic Stem Cells
Embryonic stem cells come from early-stage embryos. Though embryos are a fruitful source of stem cells, the fact that these stem cells come from embryos poses ethical challenges. The FDA has regulated these cells very carefully in the United States.
Perinatal Stem Cells
Perinatal stem cells come from umbilical cord blood and amniotic fluid and can differentiate into different types of specialized cells. However, more research is needed to determine how useful these cells can be in clinical settings.
Adult Stem Cells
Adult stem cells, which have been used in medicine since the 1950s, come from adult tissue and so do not carry an ethical burden. These cells are often derived from bone marrow or adipose tissue, also known as fat. Not long ago, we thought that adult stem cells could only be used to generate similar cell types.
We have learned, however, that stem cells from the bone marrow may be able to give rise not only to blood cells but to other types of cells as well. This newly recognized feature of adult stem cells makes them very useful in Regenerative Orthopedic and Spine medicine.
Other Types of Stem Cells
Another type of stem cell is the Induced pluripotent stem cell. These cells are adult cells that scientists have transformed into stem cells through genetic reprogramming. It is not yet known how people would react to treatments with these cells and they are currently being investigated with more clinical research.
What is stem cell therapy?
Stem cell therapy involves applying new cells that do not yet have a specific function within the body to an area that is diseased or injured. The rationale behind stem cell treatments is that these new cells can be guided to become specialized cells and can potentially regenerate damaged tissue, thereby improving health outcomes.
A major challenge of organ transplants is the availability of viable organs, and some experts view stem cells as a way of solving the same kind of medical issues that organ transplants solve without suffering from the limited supply of organs.
What is stem cell therapy controversial?
Stem cell therapy is a relatively new intervention, which means that it is inevitably accompanied by both hope and skepticism within the medical community. The utility and safety of stem cells are heavily debated. Fans of the therapy can point to compelling evidence regarding the medical benefits and safety associated with stem cell treatments.
At the same time, those who oppose stem cell therapy can cite equally compelling research that demonstrates that stem cells may not be particularly useful and that they may even cause harm. Indeed, the new federal ruling in favor of FDA regulation of stem cell therapy is a result of one such therapy that caused blindness in 3 patients.
Looking at the Science
While some of the data on stem cell treatments are promising and some of the procedures being performed appear to lead to positive outcomes for patients, there is still a lot we do not know about the long-term effects of stem cells and how they work in certain types of diseases and disorders (R). It is important to recognize that while there is accumulating scientific evidence for the potential of stem cells to help patients with a variety of disorders, the lack of regulation in the industry has also allowed for bad actors that promote stem cell therapy scams.
The FDA’s goal with regard to stem cell therapy is to protect people from procedures and clinics that are likely to harm them (R). The agency has shown a significant commitment to monitoring the ways in which stem cells are used but have struggled to keep up with the pace at which these procedures and clinics are sprouting up.
While the FDA catches up with this rapidly growing field, it is critical that patients understand the realities of currently available stem cell treatments and that not all procedures – and not all clinics – are created equal. Some clinics promote unapproved interventions with little evidence to support their medical utility. If patients can identify stem cell therapy scams, they can avoid unnecessarily undergoing and paying for ineffective or dangerous procedures.
Avoiding Stem Cell Therapy Scams
Many unsuspecting patients fall prey to unscrupulous stem cell therapy providers that claim that unapproved products or procedures will help those patients. Nonetheless, there are also stem cell therapy providers who account for scientific realities and consider the details of the patient’s condition in order to provide them with the most effective and safest stem cell treatment options available.
The best clinics develop protocols that reflect the best and latest data on stem cells and their clinical use. Renowned scientists with deep expertise in regenerative medicine are usually involved in the development of these protocols, and those who deliver the treatments have extensive and ongoing training in the procedures.
These clinics usually do not employ a one-size-fits-all approach but instead customize their treatments to each individual patient to ensure that therapies are optimized to be as safe and clinically beneficial as possible, as well as cost effective.
Navigating the options for stem cell treatment can be daunting. The best way to be sure that a stem cell treatment is safe is verifying that the procedure falls within the 2017 guidelines established by the FDA and the experience level of the treating physician. Physicians should never hesitate to answer any questions you have about their experience, potential complication rates, and their added training to perform these procedures.