By Vita Quintanilla, Genetics 23’

Author’s Note: My purpose in writing this piece is to educate the current safe applications of stem cell as misuse and damage due to the same is so prevalent in the US and abroad. While not detracting from the great advances being made in the field currently this piece is to take stock of the reality of this treatment.

Large segments of the American and world population living with medical conditions that cause significant loss of mobility and quality of life are searching for hope in Stem Cell therapy.  The unfortunate reality is that many of these “therapies” are not only ineffective but potentially harmful and the clinics that distribute them are not always properly certified. While stem cell therapies are promising, run away hope for a miracle cure coupled with unethical advertising and untested procedures have caused patients in the United States and beyond to be harmed by a potentially life saving tool. Here we will examine the current state of stem cell investigation, treatment, US Regulation, prospects in the future of medicine, and information for consumers to consider in deciding to receive a stem cell treatment.

Stem cells are undifferentiated cells that are at the start of all cell lines. Embryonic stem cells come from the blastocyst, a small clump of cells that forms several days after conception, and are pluripotent, meaning that they can give rise to any cell type (except specific embryonic tissues not present out of utero). [1] While these are the most often referred to type of stem cells there are also multipotent stem cells that can only give rise to a specific kind of tissue and are present into adulthood. Somatic cells, or differentiated cells, can be reverted to a pluripotent state. Induced pluripotent stem cells (IPS) are a growing area of interest in the field as they carry with them the possibility of culturing tissues for transplant using the existing cells of a patient thus eliminating the possibility of rejection.[2]

IPS exemplify an unfortunate reality in the whole of stem cell research, that at present widespread stem cell therapies are not ready for the general public. While these cells have great potential, a major hurdle is the cost in both time and labor required to culture them in a safe and sterile environment. A single vial of research grade cells that will produce fewer than thirty colonies in five days under ideal circumstances can cost over 1,000 dollars. This does not include the cost of facilities, culture equipment, and labor making these therapies cost prohibitive as the resulting therapy can run as far as 10,000 dollars per treatment. [3&4] Furthermore, colonies of cells are far from fully developed tissues that could potentially be implanted. A patient in critical condition in need of a transplant likely cannot wait for the cells to grow into tissue in culture, even if they can afford it.

Difficulties in access however are not the greatest barrier to stem cell therapy, but rather the lack of widespread testing and approval for the treatment of the diverse conditions for which they are sometimes advertised.  While these cells are promising for usage in widespread areas of medicine, at present they do not live up to the claims that many unscrupulous clinics make for them. US Stem Cell Clinic, with a sleek website, and moving testimonials, advertises the use of stem cells as a magical cure that make the old feel young again using stem cells to treat a host of orthopedic maladies. These claims are highly suspicious as the FDA website says, as of January 2019, that only stem cell therapies for blood disorders are approved. [5]

These cells have been proclaimed cure-alls and medical miracles by the mass media but the reality is that the research into the application of stem cells for diverse ailments in humans is not conclusive at the present moment. [5]  The FDA only approves stem cell treatments for blood disorders using stem cells from umbilical cord blood or bone marrow, but many clinics are offering stem cell treatments for everything from vision problems to COPD. The FDA recently filed two complaints against US Stem Cell Clinic LLC in Florida and California Stem Cell Treatment Inc. for marketing stem cell products that do not have the proper approval and for having unsafe manufacturing conditions that compromised sterility and patient safety. Patients filed lawsuits against California based stem cell supplier Liveyon who sold umbilical cord stem cells contaminated with E. Coli that resulted in sepsis and several patient hospitalizations after the stem cells were used for unapproved treatments. [6]  In a recent lawsuit Florida based US Stem Cell was ordered to cease and desist, destroy all stem cells in their possession and pay for twice annual facilities inspections after taking cells from fat and injecting them into the eyes of patients causing five women to be blinded. In a 2018 statement FDA Commissioner Scott Gottlieb, M.D. said “We support sound, scientific research and regulation of cell-based regenerative medicine, and the FDA has advanced a comprehensive policy framework to promote the approval of regenerative medicine products. But at the same time, the FDA will continue to take enforcement actions against clinics that abuse the trust of patients and endanger their health” [7] The FDA, has in the past been accused of slowing down progress with novel treatments, but in the case of stem cells it is apparent that their actions hold patient safety as first priority, protecting the public from doctors and companies that value monetization over public health.

Patients in the United States have been harmed by these clinics including adverse injection site reactions, migration of cells to the improper location, the failure of cells to work in the desired way, and even the growth of tumors. Clinics that operate these studies may even be operating criminally as the FDA has pressed charges against these clinics in the past in the form of permanent injunction, an order to cease and desist permanently. [7]

Patients are often motivated to take these risky treatments because there is no other hope for a cure, however, unapproved treatments can make the condition worse or even lead to death. The dangers of receiving unapproved therapies is illustrated in the case of a 38-year-old man, who developed a spinal tumor after a stem cell treatment in preformed in Portugal where doctors injected cells taken from his nose into his spine. The treatment was attempting to cure paralysis in his legs and arms. It had no effect on his paralysis, but twelve years later the tumor that formed further limited his mobility and quality of life as his bladder control and motor function in arms steadily declined. Complications have been even more dire as a thirteen-year-old male in Israel who was treated at a clinic in Moscow for Ataxia telangiectasia, which affects the nervous system, died of a tumor that arose from donor cells. These are not isolated instances of unsuccessful treatment in patients that were already ill, the stem cells themselves were directly the cause of degeneration in the patients, and more than 19 deaths confirmed by the National Institute of Health as of 2018. [8&9]

Predatory clinics that perform these unapproved procedures can be especially hard to identify. Many have sleek well-designed websites with official looking personnel and lofty claims of unrealistic success rates and propositions for stem cells as cures for many diverse and at times totally unrelated disorders. Many clinics are located in Florida and Southern California however there are hundreds of clinics across the United States.  [10]*** Patients should be advised to do some research into these claims and check to see if the clinic in question as well as the treatment has FDA approval. A good strategy for determining the legitimacy of a clinic is to do research on the main doctors performing the procedure. If a clinic is claiming to be able to cure numerous unrelated and debilitating disorders, the doctors performing these procedures should be of high esteem in the community and have visible external measures to the importance of their work or the prestige of their practice. If this is not the case the patient should proceed with great caution.

The issue of deceptive stem cell clinics is not a mere issue of public health but an example of a greater problem, a break between scientific community and the public perpetuated by a few unscrupulous characters for the sake of profit. Stem cells have the potential to be life saving tools and usher in a whole new chapter of regenerative medicine, but if the reputation of this technology continues to be tarnished by clinics that do not abide by the laws and conventions put in place to keep consumers safe, this technology may never get an opportunity to reach its full potential.While stem cells have great potential for diverse treatments at some point in the future, at present their efficacy and safety for regenerative medicine has not been firmly established in the context of current technology. Not all stem cell treatments are to be feared, stem cell treatments for some blood disorders have been shown to be effective and safe. At some point in the future when culture and delivery techniques improve stem cells could revolutionize transplant and regenerative medicine.  At present the best course of action for consumers in regard to these therapies is to partake only in treatments or clinical trials operating with the approval of the FDA, and keep up with developments in the field by reading peer reviewed papers published in reputable journals. Exercise great caution but do not lose hope for the future. Stay current with research and, considering the risks and benefits, consumers may choose to enroll in FDA supervised clinical trials that adhere to the three phase clinical trial process, but always be sure to exclusively receive treatment from FDA regulated and approved clinicians.

Sources

1. Yu, Junying, and James Thomson. “Embryonic Stem Cells.”National Institutes of Health, U.S. Department of Health and Human Services, 2016, stemcells.nih.gov/info/Regenerative_Medicine/2006Chapter1.htm. 
2. “Home.” A Closer Look at Stem Cells, www.closerlookatstemcells.org/learn-about-stem-cells/types-of-stem-cells/.
3. McCormack, Kevin. “Patients Beware: Warnings about Shady Clinics and Suspect Treatments.” The Stem Cellar, CRIM, 19 Jan. 2016, blog.cirm.ca.gov/2016/01/19/patients-beware-warnings-about-shady-clinics-and-suspect- treatments/.
4. https://www.atcc.org/search?title=Human%20IPS%20(Pluripotent)#q=%40productline%3DL035&sort=relevancy&f:contentTypeFacetATCC=[Products]
5. Office of the Commissioner. “Consumer Updates – FDA Warns About Stem Cell Therapies.” U S Food and DrugAdministration Home Page, Center for Drug Evaluation and Research, 16 Nov. 2016, www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm.
6. William Wan, Laurie McGinley. “’Miraculous’ Stem Cell Therapy Has Sickened People in Five States.” The Washington Post, WP Company, 27 Feb. 2019, www.washingtonpost.com/national/health-science/miraculous-stem-cell-therapy-has-sickened-people-in-five-states/2019/02/26/c04b23a4-3539-11e9-854a-7a14d7fec96a_story.html.
7. Commissioner, Office of the. “FDA Seeks Permanent Injunctions against Two Stem Cell Clinics.” U.S. Food and Drug Administration, FDA, 9 May 2018, www.fda.gov/news-events/press-announcements/fda-seeks-permanent-injunctions-against-two-stem-cell-clinics.
8. Bauer, Gerhard, et al. “Concise Review: A Comprehensive Analysis of Reported Adverse Events in Patients Receiving Unproven Stem Cell-Based Interventions.” Stem Cells Translational Medicine, John Wiley & Sons, Inc., Sept. 2018, www.ncbi.nlm.nih.gov/pmc/articles/PMC6127222/#!po=19.4444.
9. Flaherty, Brittany, et al. “Case Highlights the Risks of Experimental Stem Cell Therapy.” STAT, Staten News, 11 July 2019, www.statnews.com/2019/07/11/canada-case-long-term-risks-experimental-stem-cell-therapy/.
10. https://usstemcellclinic.com/ [10]
11. Commissioner, Office of the. “Step 3: Clinical Research.” U.S. Food and Drug Administration, FDA , 4 Jan. 2018, www.fda.gov/patients/drug-development-process/step-3-clinical-research.
12. Hiltznik, Micheal. “Column: Judge Throws the Book at a Clinic Offering Unproven Stem Cell ‘Treatments’.” Los Angeles Times, Los Angeles Times, 26 June 2019, www.latimes.com/business/hiltzik/la-fi-hiltzik-stem-cell-injunction-20190626-story.html.