UConn Health

Unproven “stem cell” therapy injuries are more common than we realized

/ Yimy Villa / 1 Comment
Jaime Imitola, senior author of the paper and director of the Comprehensive Multiple Sclerosis Center at UConn Health

Here at CIRM we only fund clinical trials that meet the rigorous standards outlined by the Food and Drug Administration (FDA). These requirements are not only necessary to properly evaluate how effective a potential treatment may be, but they are also important in fulfilling the Hippocratic Oath to “first, do no harm”.

The journey from the bench to the bedside for a potential treatment is one that is long, arduous, and often filled with setbacks. Unfortunately, there are those affected with various diseases that do not have the luxury of time. People who have suffered brain or spinal cord damage, or have been diagnosed with neurological disease, are often frustrated by the lack of treatments available to help them. That frustration can make them susceptible to the false promises made by predatory clinics, which operate outside of FDA oversight and offer “stem cell” treatments that are unproven and cost upwards of $50,000. In the midst of a global pandemic, some of these predatory clinics are even promoting false cures for COVID-19.

In an effort to better understand how often people gravitate to these predatory clinics, a phenomenon known as stem cell tourism, Dr. Jaime Imitola and a team of researchers at UConn Health conducted a nationwide survey of academic neurologists’ experiences in stem cell tourism complications. The study also evaluated the level of physician preparation to counsel and educate patients. These neurologists will typically have patients come to them asking for permission, a kind of “clearance” in their eyes, to get these unapproved stem cell treatments.

The results of the survey were very revealing. Of the neurologists who responded to the survey, one in four had a patient with complications related to stem cell therapy, which includes infections, strokes, spinal tumors, seizures, and even death. Additionally, 73% of neurologists responding to the survey said they felt that having more educational tools to discuss the issue with patients would be helpful.

In a press release, Dr. Imitola elaborated on the importance of this study.

“It is really shocking that only 28% of board-certified neurologists feel completely prepared to discuss this important issue with their patients…The ultimate goal of this research is to be able to determine the extent of the complications and the readiness of neurologists to counsel patients. All of us are interested in bringing real stem cells to the clinic, but this process is arduous and requires a great level of rigor and reproducibility.”

Dr. Imitola and his team also plan on starting a national patient registry, where physicians can report complications from stem cell tourism procedures. This would not only provide a better sense of the problem at hand, it would gather data that physicians could use to better educate patients.

The full results to this study were published in Annals of Neurology.

CIRM has produced a short video and other easy to digest information on questions people should ask before signing up for any clinical trial. You can find those resources here.

CIRM has also published findings in Stem Cells Translational Medicine that discuss the three R’s–regulated, reliable, and reputable–and how these can help protect patients with uniform standards for stem cell treatments .

Old cells need not apply: how a stem cell’s age can impact potential treatments

/ Yimy Villa / 2 Comments

Getting older is a normal, at times existential, part of life. The outward changes are abundant and noticeable: thinning of the hair, greying of the hair, and added lines to the face. There are also changes that happen that are not so abundantly clear in terms of outward appearance: slowing of healing time for bone fractures and a gradual loss of bodily function. The process of aging poses one very fundamental question — Could understanding how stem cells age lead to a greater understanding of how diseases develop? More importantly, could it guide the approach towards developing potential treatments? Two different studies highlight the importance of evaluating and understanding the process of aging in stem cells.

The first study, led by Dr. Michael Fehlings, looked at the impact of donor age in relation to stem cell therapies for spinal cord injuries (SCI). Dr. Fehlings, with a team of investigators from the University of Toronto and Krembil Research Institute, University Health Network, used an adult rat model to look at how cells derived from young vs. old stem cells affected tissue regeneration and recovery after a spinal cord injury.

Some rats with a SCI received cells derived from stem cells in the umbilical cord blood, which are considered “young” stem cells. The other rats with a SCI received cells derived from stem cells in the bone marrow, which are considered “old” stem cells. The results showed, ten weeks after treatment, that rats given the “young” stem cells exhibited a better recovery in comparison to those given the “old” stem cells.

In a press release, Dr. Fehlings stated that,

“Together, this minimally invasive and effective approach to cell therapy has significant implications on the treatment of traumatic cervical SCI and other central nervous system injuries. These results can help to optimize cell treatment strategies for eventual use in humans.”

The full results to this study were published in Stem Cells Translational Medicine.

The second, separate study, conducted by Dr. Stephen Crocker at UConn Health, looks at brain stem cells in people with multiple sclerosis (MS), a neurodegenerative disease caused by the inflammation and destruction of the insulation around the nerves, also known as myelin. Problems with insulation around the nerves can prevent or complicate the electrical signals sent from the brain to the body, which can lead to problems with walking or other bodily movements.

Drawing of a healthy nerve cell with insulation (left) and one damaged by multiple sclerosis (right). Image courtesy of Shutterstock

Dr. Crocker and his team found that brain stem cells in patients with MS look much older when compared to the brain stem cells of a healthy person around the same age. Not only did these brain stem cells look older, but they also acted much older in comparison to their healthy counterparts. It was also discovered that the brain stem cells of MS patients were producing a protein that prevented the development of insulation around the nerves. What is more remarkable is that Dr. Crocker and his team demonstrated that when this protein is blocked, the insulation around the nerves develops normally again.

In a press release, Dr. Valentina Fossati, a neurologist at the New York Stem Cell Foundation who evaluated these brain stem cells, stated that,

“We are excited that the study of human stem cells in a dish led to the discovery of a new disease mechanism that could be targeted in much-needed therapeutics for progressive MS patients.”

The complete study was published in the Proceedings of the National Academy of Sciences (PNAS).