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accreditation statistics

As of April 1, 2021

Cellular Therapy Entities

  • Accredited: 237
  • Applicants: 21

Cord Blood Banks

  • Accredited: 58
  • Applicants: 8

A complete list of accredited organizations can be found at www.factwebsite.org.

Congratulations to the following organization for achieving its initial FACT accreditation:

GW Cancer Center Stem Cell Transplantation and Cellular Therapy Program, Washington, DC

Director: John Barrett, MD

Adult Autologous Hematopoietic Progenitor Cell Transplantation, Peripheral Blood Cellular Therapy Product Collection, and Cellular Therapy Product Processing with Minimal Manipulation

The Importance of Both Hope and Information when Battling Disease: A FACT Accreditation Coordinator’s Experience

Posted in :: 2020 Volume 7 :: Thursday, September 17th, 2020

By: Dina Becirovic, MPH, FACT Accreditation Coordinator

I lost a loved one to testicular cancer. At the time of his death two years after diagnosis, my cousin was more alive than most living people. He was an example of someone willing to try different treatments and travel far in the hopes of a cure.  He was in his early 40s and living in Bosnia when he was diagnosed early enough that the tumor could be removed. The follow-up scans showed the involvement of the lymph nodes, which were also removed. Subsequent scans showed elevated cancer markers, with additional scans showing nodules in the right lung and kidneys. He remained hopeful that he could still be cured. Holding onto hope, he turned to herbal supplements and cocktails. He would drink fluids that would “boost his immunity.”

With a poor prognosis, his last resort was coming to the United States. The cancer was inoperable at this point as it metastasized close to the walls of the aorta.  With the condition that far advanced, his treating physician indicated the stem cell transplant would yield a 10% chance of recovery and cancer remission. He passed away a week after receiving an autologous transplant, two years after his diagnosis. Even in his worst days, he was full of life, unscathed, hoping to see his son again. His experience showed the perseverance, hope, and desperation of someone who wanted to live.

A couple of months ago, I had the opportunity to attend a webinar on the topic of stem cell tourism (Gulera, 2020). This presentation reminded me of what I had already personally seen regarding the extent people are willing to go out of desperation, hope, and a desire to live.  My cousin’s experiments with outside remedies did not touch the surface compared to the extreme examples shown during the webinar. Stem cell tourism is often presented to patients as having the ability to treat or cure conditions and diseases such as diabetes, stroke, paralysis, or cerebral palsy (ISSCR, 2014). For example, because of a stem cell treatment in this setting, an individual lost an eye. Perhaps the most gruesome example of stem cell tourism was that of a man with an aggressive growing mass of someone else’s cells in the lower portion of his spine. For treatment and in hopes of finding a cure for quadriplegia post-stroke, that man paid $300,000 for injections (Kolata, 2016).

The International Society for Cell & Gene Therapy (ISCT) describes stem cell tourism as  “any unproven or insufficiently proven cell therapies proposed to patients as “treatments or therapies” for a specific financial cost and without recognized biological and medical proofs of safety and efficacy (i.e., without a positive benefit-risk assessment in place)” (ISTC, 2015, p.9).  These therapies are often offered to patients in clinics locally and worldwide. Most therapies are not part of the domain of conventional clinical trials, and no regulatory monitoring or information about risks or benefits is available. Furthermore, unproven cell therapies are characterized by the inability to confirm product quality and efficacy due to unclear scientific foundation or experimental procedures or consistency in cell manufacturing, inadequate consent forms, and failure to support clinical use due to incomplete research on action mechanism and biological function (ISCT, 2015).

The International Society for Stem Cell Research (2014) developed a Patient Handbook on Stem Cell Therapies, including stem cell tourism.  This resource provides a set of questions one might ask of the clinic or their provider. It also includes the warning signs a patient should look for should they ever find themselves in this situation.

FACT Standards require independent oversight by appropriate agencies, such as an Internal Review Board, ethics boards, and regulatory agencies; the disclosure of risks and benefits; and the disclosure of the cell source and how the cells will be collected, manufactured and administered. Additionally, FACT Standards reinforce training and continued annual competence of stem cell transplant physicians, advanced practice providers, and staff that are providing patient care in the stem cell transplant field. These requirements would mitigate the risks of stem cell tourism of clinics that voluntarily comply with them.

For a list of patient-related resources on Stem Cell Tourism and similar topics, visit the FACT website. Whatever you do for yourself or a loved one, be informed.

References

Gulera, I. (2020). Stem Cell Tourism [Webinar]. AABB Spanish Subsection.

Kolata, G. (2016, June 23). A Cautionary Tale of ‘Stem Cell Tourism’. https://www.nytimes.com/2016/06/23/health/a-cautionary-tale-of-stem-cell-tourism.html.

International Society for Cellular Therapy. (2015). ISCT Presidential Task Force on the Use of Unproven Cellular Therapies: Reference Guide. https://isctglobal.org/page/PTF2015 .

Mummery, C. L., Stolpe, A. van de, Roelen, B. A. J., & Clevers, H. (2014). Chapter 11. In Stem cells: scientific facts and fiction. Elsevier/AP, Academic Press is an imprint of Elsevier. https://doi.org/https://doi.org/10.1016/B978-0-12-411551-4.00011-8