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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

 


FACT Events at ISCT Were a Success!

Posted in :: 2019 Volume 6 :: Thursday, June 13th, 2019

Chrissy Gordon: A Patient Perspective

FACT was honored to have its Cellular Therapy and Cord Blood Inspection and Accreditation Workshop in Melbourne, Australia opened by Ms. Chrissy Gordon, a recipient of an unrelated bone marrow transplant in 2000. Chrissy’s inspirational story of diagnosis, treatment, transplant, challenges, and successes over the past twenty years highlighted the importance of continuing to pursue improvements in the quality of patient care and advancing the promising developments in the field of cellular therapy.  Diagnosed with leukemia in 1999 at the age of 28, Chrissy was treated in Melbourne, but her matched donor was found half way around the globe in Omaha, Nebraska where the donation was made at the University of Nebraska Medical Center.  We first met Chrissy when she and her husband Dave visited Omaha to celebrate the 70th birthday of her marrow donor, Mr. Ken Vice of Lincoln, Nebraska.

Bone marrow transplant recipient Chrissy Gordon and her husband Dave shared her transplant story during the FACT Accreditation Workshop. 

ISCT-FACT Quality Boot Camp 2019

The 2019 ISCT Annual Meeting in Melbourne kicked off during the Pre-Conference Day with a packed house at the ISCT – FACT Quality Boot Camp on Wednesday, May 29, 2019.  Patrick Hanley, PhD presented timely information on incorporating immune effector cell activities into existing quality management programs. Guy Klamer, PhD discussed the importance of document control and common issues faced by cord blood banks.  Participants were actively engaged during an interactive session with Phillip Johnson on risk management, and were presented with several case scenarios and asked to assess the risk.  With validations being an important and challenging component of every cellular therapy facility, Robyn Rodwell, PhD and Annette Tricket, PhD provided details on the validation process and examples of their organizations’ results.  FACT’s Quality Manager, Heather Conway, addressed the important subject of auditing, focusing on the minimum requirements of an audit report and the “Five Whys.” The day concluded with a hands-on exercise using the ISBT 128 Audit Tool for Cellular Therapy.  The day was a great success and we look forward to future quality boot camps discussing core quality topics valuable to your organization. If you have ideas for future quality sessions, email  your ideas to FACT@UNMC.edu.

Quality Boot Camp participants work together on an activity applying quality principles to real-world scenarios.

 


New NMDP/Be the Match Video Series Available for Patients and Families

Posted in :: 2016 Volume I :: Thursday, April 14th, 2016

Many Clinical Program Directors and Quality Managers believe socioeconomic factors influence clinical outcomes after transplant. The NMDP/Be the Match has several resources to help patients and their families understand the seriousness of transplants and the care patients need. A new resource recently announced is a Basics of Blood and Marrow Transplant video series.

According to NMDP/Be the Match, “Whether your patient is going for a transplant consultation or is preparing for transplant, our new video series can help patients, caregivers, and families understand what to expect before, during, and after transplant.”

There are 10 easy-to-understand videos that use both animation and interviews with patients, caregivers, and transplant clinicians. Topics include the basics of transplant, the difference between an autologous and allogeneic transplant, HLA matching, engraftment, what it is like to be a caregiver, and life after transplant.

The Basics of Blood and Marrow Transplant videos can be used individually or as a complete series. The short videos range from 2 to 6 minutes in length. The free videos are coming soon in Spanish and on DVD.

This video series is a useful means to prepare patients and families for transplantation and prepare them for the long and difficult journey ahead. Such education may empower them to actively participate in the recovery process, thereby improving outcomes.

View the videos and share with your patients