Just like cellular therapy itself, donor registry and regulatory requirements evolve over time. As a voluntary, peer-based accrediting organization, FACT reviews updates to requirements that are relevant to our Standards and affect our accredited organizations. We take every opportunity to provide input on these requirements as a value-added service to the FACT community.
There have been notable requests for public comments in the first half of 2022, and FACT committees, task forces, and leadership have evaluated draft requirements and submitted comments when determined to be appropriate. These include:
- Proposed NMDP/Be the Match Participation Criteria A00960, titled, “U.S. Apheresis and Collection Center Participation Criteria”: FACT expressed support for NMDP/Be the Match’s efforts to simplify and streamline criteria, requested clarification regarding whether the proposed criteria reflect a change in current practice regarding Apheresis Centers’ option to decline the opportunity to share NMDP collection center adult results with other NMDP clients, and reiterated support of retaining this option for NMDP collection centers.
- Draft Version of 25th Edition NMDP Standards: FACT expressed support for the National Marrow Donor Program (NMDP)/Be the Match’s efforts to streamline and simplify its Standards and provided recommendations for increasing clarity regarding the requirements and the scope of related accrediting organizations (e.g., FACT, the Joint Accreditation Committee of ISCT & EBMT (JACIE), and WMDA/NetCord).
- Draft guidance from the FDA proposed rule titled, “Medical Devices; Immunology and Microbiology Classification of Human Leukocyte, Neutrophil and Platelet Antigen and Antibody Tests”: FACT expressed its support of the comments submitted under separate cover by the American Society for Histocompatibility & Immunogenetics (ASHI) and opposed FDA’s proposal to classify HLA devices into class II with special controls.
Read the proposed FDA rule
- Draft guidance from the Food and Drug Administration (FDA), titled: “Considerations for the Development of Chimeric Antigen Receptor (CAR) T Cell Products”: FACT comments focused on the importance of relationships between cellular therapy product manufacturing companies and the health care institutions in their collection and treatment site networks to enhance patient safety, product efficacy, and patient access while minimizing the burdens on the health care institutions. FACT also recommended references to ISBT 128 coding and labeling and ASTCT consensus criteria for grading cytokine release syndrome and neurologic toxicities.
Read the draft FDA guidance
The National Marrow Donor Program®(NMDP)/Be the Match® has announced proposed changes to U.S. Apheresis and Collection Center Participation Criteria, which will be published in a combined document.
The changes support simplification and alignment with FACT and/or AABB accreditation. All NMDP/Be The Match apheresis and collection center Network partners are expected to hold the appropriate accreditation or demonstrate application for accreditation by Oct. 1, 2022. If a center is not yet accredited, it should contact the Partner Liaison team at the beginning of 2022 to discuss the plan for pursuing accreditation.
Comments on these proposed changes can be submitted by November 16, 2022 to PartnerLiaisons@nmdp.org. Discussion of the proposed changes can also take place during quarterly meetings with Partner Liaisons in November.
The Effect of the COVID-19 Pandemic on Cord Blood Banking
Monday, June 22, 2020, at 9:00 am ET, 13:00 GMT
Presenters will discuss how cord blood banks have been managing through the COVID-19 pandemic:
Heidi Elmoazzen, PhD
Canadian Blood Services’ Cord Blood Bank & Stem Cell Manufacturing
Dr. Elmoazzen will discuss the impact of the COVID-19 Pandemic on stem cell transplantation in Canada including Canadian Blood Services’ Cord Blood Bank Stem Cell Registry and Public Cord Blood Bank.
Roger Horton, PhD
Anthony Nolan Cord Blood Bank, United Kingdom
Dr. Horton will summarize the demand for UK cords between Jan-May 2019 and 2020, and compare both years to give an idea on the impact of the pandemic on operations. He will provide detail on collections, processing, storage, distribution, product protection, and staffing to demonstrate how Anthony Nolan has adapted or mitigated each issue. Where possible Dr. Horton will compare Anthony Nolan practices with other European partners.
Arvin Faundo, MD
Cordlife Group Limited, Singapore
Dr. Faundo will discuss how the coronavirus pandemic is affecting the operations of the Cordlife Group Limited bank and identify the pandemic-related problems that are specific to private or family cord blood banks.
Donna Regan MT(ASCP), SBB
Donna will present statistics before and through the pandemic (CB orders, shipments, transplants) and the promotion of services that supported this activity. She will also highlight the unique steps taken by the registry to support unrelated transplant, not least of which is leveraging the cord blood story to cryopreserve all unrelated products prior to patient conditioning.
Lydia Foeken, LN
WMDA, Executive Director
By Andra Moehring, MHA, FACT Standards Development Manager
Dr. John Hansen, physician scientist and emeritus faculty member of Fred Hutchinson Cancer Research Center, died of pancreatic cancer on July 31, 2019. Dr. Hansen was well known for his innumerable contributions to the field of blood and marrow transplantation, his pioneering research and discoveries in Immunogenetics, his pivotal role in establishment of global registries of potential unrelated stem cell donors, and his generosity in mentoring others.
Dr. Hansen was also a founding member of the volunteer expert panel that became FACT’s Histocompatibility Committee, responsible for development of the guidelines by which to measure organizations that accredit histocompatibility services in hematopoietic cellular therapy. FACT accreditation of clinical transplant programs and cord blood banks requires histocompatibility laboratories to meet appropriate standards. As FACT extends accreditation services globally, these histocompatibility guidelines are critical to advancing quality care for patients. Dr. Hansen’s foundational contributions and willingness to share his expertise will continue to impact patients and the cellular therapy field worldwide.
The Cellular Therapy Community Corner provides a forum for the cell therapy community that includes educational opportunities, recent publications, and upcoming events.
ASGCT Debuts Patient Education Program
The American Society of Gene & Cell Therapy (ASGCT) announced the first release of the Society’s Patient Education program, a new initiative for 2019. Designed by ASGCT committee volunteers in coordination with patient advocacy groups, the new patient-centered portal is designed to educate and inform patients, families, and the public on the status and promise of gene and cell therapies.
The following Sessions are now live on ASGCT.org:
Gene Therapy 101, which includes the following information:
Disease Treatments, which includes the following information:
- Spinal Muscular Atrophy
- X-Linked Myotubular Myopathy
- Leukodystrophy (coming February 15)
- Blood Disorders (coming February 22)
- Inherited Retinal Disorders (coming February 28)
All topics ultimately provide patients and patient advocates with video, text, and infographic resources to share with various stakeholders. ASGCT encourages people to share these resources with their friends and family.
FDA Outlines Planned Policies to Advance Development of Safe and Effective Cell and Gene Therapies
Statement from FDA Commissioner Scott Gottlieb, M.D. and Peter Marks, M.D., Ph.D., Director of the Center for Biologics Evaluation and Research
On January 15, 2019, FDA announced its plans to provide policy guidance and advance its drug development network over the coming year in response to increases in cell and gene therapy investigational new drug (IND) applications. The FDA anticipates receiving more than 200 INDs per year by 2020 and approving 10 to 20 cell and gene products a year by 2025.
The full statement outlines FDA’s policy agenda as it relates to these technologies.
Find a clinical trial through the Jason Carter Clinical Trials Program Offered by The National Marrow Donor Program®/Be The Match®
The National Marrow Donor Program®/Be The Match® is offering a new program, The Jason Carter Clinical Trials Program, designed to help patients with blood cancers or blood disorders and their families find and join clinical trials. Funding was provided by the Carter family, in memory of their son and brother, Jason Carter. This free program offers:
- One-on-one telephone support and information from a clinical trial nurse to help patients and families navigate their clinical trial search.
- Easy-to-use, web-based search tool to find relevant clinical trials: JasonCarterClinicalTrialsProgram.org
- Easy-to-understand educational resources for patients and families to learn about cancer treatment options and clinical trials.
On the JCCTP.org website, there are patient-friendly clinical trial descriptions related to leukemia, lymphoma, MDS, aplastic anemia, and more. Treatments in some of these clinical trials include blood or marrow transplant, but many others trials include the latest cell therapies such as CAR T and immunotherapies.
Patients can also apply for financial assistance from the Drs. Jeffrey and Isabel Chell Clinical Trials Travel Grant. This grant works to offset the cost of travel related to clinical trial participation. Grant eligibility information and application are available on JasonCarterClinicalTrialsProgram.org.
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.