What are the risks and considerations of using stem cells?

Author: Sharon Jang , Vanessa Mok | Reviewer: Peggy Assinck | Published: 13 May 2020 | Updated: ~

Even though Health Canada and USA Food and Drug Administration (FDA) have not yet approved of any stem cell therapies for SCI in Canada, some private clinics around the world are already selling these treatments before establishing safety and effectiveness. In Canada, offering stem cell therapies is illegal unless it is for research purposes. Before you decide, consider the following points below with a health care provider. Use these points to think critically about what is being advertised.

As described in this article, there is a lack of evidence supporting the use of stem cell therapy for spinal cord injury. Stem cell therapy is being explored as a treatment for many types of medical conditions; however, there is only strong evidence that supports its use with blood or immune system disorders that are often experienced after cancer. Currently, scientists are unsure how to repeatedly produce positive effects with the use of stem cell therapy for individuals with SCI. In addition, there remain many uncertain aspects of stem cell therapy such as knowing which type of stem cell is most effective for replacing different tissues, how these stem cells should be manipulated to produce the required cells, and what is the best way to deliver stem cells to the target area.

There are many safety risks associated with stem cell treatments, and these risks may be higher for individuals with spinal cord injuries. Some stem cell marketers may emphasize that a treatment is safer if the cells are coming from your own body; however, this does not guarantee safety. If the stem cells are grown and multiplied before being injected into your spinal cord, the cells may lose some important properties and traits in the process, such as the ability to control growth. This may lead to the development of various tumors and/or cancers. In addition, when the cells are removed from your body, it is possible that they be exposed to bacteria or viruses prior to being re-transplanted into your spine. There is also a chance that complications may arise which may lead to short- or long-term health problems. This may lead to your injury or symptoms becoming more difficult to manage.

In clinical trials with people with SCI, there have been multiple adverse events resulting from stem cell therapy. The majority of stem cell studies conclude that transplantation is relatively safe due to the lack of serious safety problems or complications observed. Mild adverse events are infrequently reported in studies, but some have been documented. Some examples that have been reported include urinary tract infections, pain, hypothermia, headaches, increased spasticity, pressure sores, and depression. Serious adverse events that have been noted in research studies include:

• • the worsening of motor functioning
  • development of a cyst on the spine (which causes a concern for cancer)
  • collection of fluid along the surgical site
  • meningitis, resulting in a decrease in AIS score
  • worsening of sensation (e.g., worsened symptoms of tingling, decrease in sensation)

However, it is important to note that these adverse effects were only monitored over the period of the study. Currently, long term effects and side effects of stem cell therapy is unknown. Further longitudinal research is required.

As the use of stem cell therapy is not currently approved by the government, most often government health programs and insurance companies will not cover the costs. The costs of receiving stem cell therapy can be very high. On top of the cost for the treatment (being in the tens of thousands of dollars itself), there is the cost of travel, accommodations, and other fees. In addition, travelling for stem cell therapy may require you to go through a medical procedure without the support of all your family and friends.

Receiving an experimental treatment is not the same as participating in a clinical trial. If you choose to receive stem cell therapy from a private clinic, you may be ineligible to participate in future clinical trials. Participating in a clinical trial is advised over receiving stem cell therapy from an unregulated private clinic, as:

• • Clinical trials are overseen by an independent medical ethics committee. This group of people is there to protect your rights and safety as a participant.
  • Clinical trials require some safety and efficacy testing before trying it in humans. This ensures that the treatment is relatively safe and effective.
  • By participating in a clinical trial (research), you are contributing back to the pool of knowledge. When you partake in a research study, you help scientists learn more about stem cell therapy and the safety or effectiveness of it.
  • There is no cost for the treatment in a clinical trial, as participants are not required to pay to partake in research studies.

Private stem cell clinics often use overly positive/ optimistic advertisements that may be misleading.³¹

Unapproved stem cell marking websites often feature many patient testimonials in addition to references to research studies. The use of testimonials may be very persuasive, but may be misleading. Some of the positive benefits that these individuals may be feeling may be the result of the placebo effect. Given that many people who go in for stem cell therapy treatment have a strong belief that it will work, they may perceive less pain or greater sensation after their treatment. Patient anecdotes should not be held equal to research evidence supporting the use of stem cell therapy.

Additionally, many private stem cell therapy clinics will try to sell the treatment by citing multiple research studies to build credibility. In reality, these research articles often have no direct association with stem cell therapy specific to spinal cord injuries. Currently, there is a lack of high-quality research studies on stem cell therapy. As a result, many of the human-based studies cited are low quality and are not specific to spinal cord injury, and some reports are based on animal trials.