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AABB CellSource - January 2020

AABB Cellsource
An Update on Cell Therapy News from AABB  |JANUARY 2020
HIGHLIGHTS
IN THIS ISSUE
ANNOUNCEMENTS
Experience the Cellular Therapies Certificate Program for That Professional Edge 
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The AABB Cellular Therapies Certificate Program, produced in partnership with the George Washington University, is a self-paced, online program designed for professionals interested in expanding their knowledge of CT. The program features 12 narrated modules covering scientific, operational and regulatory topics. Students who work through the modules, complete each assessment with a score of 80% or higher and complete a program evaluation form will receive a certificate of completion. The program also provides an opportunity to earn up to 37 continuing education credits (CEs).
eCasts in CT in 2020
Registration for AABB eCasts is available for both individuals and groups, and institutions can host eCasts for employees at one or more sites. Participants in group eCasts are eligible to earn continuing education credit. On-demand recordings of eCast sessions are available for those unable to attend a live eCast.
 
Upcoming CT eCasts:
Cellsource
 
Editor:
Christina M. Celluzzi, PhD
 
Contributors:
Kathy Loper,  MHS, MT(ASCP)
Maysum Chaudri
 
AABB Center for Cellular Therapies
4550 Montgomery Avenue, Suite 700, North Tower, Bethesda, MD 20814, +1.301.907.6977
 
IN THE NEWS
Deadline for Education Proposal Submission for 2020 AABB Annual Meeting Ends Jan. 31
There is still time to help build an exciting educational session program for AABB’s premier event, the 2020 AABB Annual Meeting, to be held Oct. 3-6 in Baltimore. Session proposals are due by Friday, Jan. 31. AABB’s Annual Meeting Education Committee (AMEC) is looking forward to reviewing and selecting a wide range of education topics. This list of key topics suggested by Annual Meeting attendees and the AMEC is a helpful resource when thinking of session proposal topics. For more information and to prepare a proposal for submission, download the Education Session Proposal Guide. Late or incomplete submissions will not be accepted. Submit your engaging, forward-thinking proposal today before it is too late.
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Nominations Requested to Honor Those Who Contribute to Cellular Therapies and Transfusion Medicine 
AABB encourages members to nominate their colleagues for 2020 and 2021 AABB Memorial Awards. The awards honor those who have made significant contributions to the fields of transfusion medicine and cellular therapies by recognizing achievements in administration, immunohematology, quality and innovative research, as well as overall outstanding service to these fields. Individuals can nominate candidates by completing and submitting the online nomination form and supporting documentation by Friday, Jan. 31. AABB will present the awards during the 2020 Annual Meeting in Baltimore, Md., or during the 2021 AABB Annual Meeting in Anaheim, Calif. 
REGULATORY AND GOVERNMENT UPDATE
NHLBI Releases Report of 2019 Research Achievements, Planned 2020 Activities
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The National Heart, Lung and Blood Institute (NHLBI) recently released a brochure highlighting its major programs and partnership activities, advances in research funded by the Institute during 2019, and research activities planned for 2020. The report points out NHLBI’s efforts to develop cures and deliver better care for patients with sickle cell disease (SCD) and includes an update on the progress toward gene-based cures for SCD and the approval of new medications to manage the condition. NHLBI-supported research seeks to reduce graft-versus-host disease after a blood or bone marrow transplant.
FDA Extends Program for Cellular Therapies Manufacturers
FDA extended the agency’s Tissue Reference Group Rapid Inquiry program (TRIP) to help manufacturers of HCT/Ps obtain a rapid, preliminary, informal, non-binding assessment from FDA regarding how specific HCT/Ps are regulated. The program will operate until March 31. Instructions for submitting a TRIP request are available online.
FDA Issues Public Safety Notification About Exosome Products
FDA issued a public safety notification following reports of patients in Nebraska experiencing serious adverse events after treatment with unapproved products marketed as containing exosomes. In its notice, FDA emphasized that there are currently no FDA-approved exosome products. Exosomes used to treat diseases and conditions in humans are regulated as drugs and biological products that are subject to pre-market review and approval requirements. FDA is working with state and federal government partners to assess the situation. FDA asks consumers and health care professionals to report any adverse events related to exosome products or other unapproved products to FDA's MedWatch adverse events reporting program.
AABB Supports PACT Act
AABB co-signed a letter supporting the Protect Access to Cellular Transplant Act (PACT) Act (S. 1286/H.R. 2498). AABB previously submitted letters in support of the PACT Act, which is being spearheaded by NMDP/Be the Match and would create a separate Medicare payment for donor search and cell acquisition cost for allogeneic HCT. The policy would align payment policy for HCT with that for solid organs. 

 
RESEARCH FOCUS
Four U.S. CRISPR Trials Editing Human DNA to Research New Treatments
CRISPR technology is a simple yet powerful tool for editing genomes. It allows researchers to easily alter DNA sequences and modify gene function. Its many potential applications include correcting genetic defects and treating and preventing the spread of diseases. In the past 12 months, four clinical trials have been launched in the United States using CRISPR to treat and potentially cure patients of serious medical conditions. Trials include editing patients’ T cells to fight cancer, boosting fetal hemoglobin in patients with sickle cell disease, editing donor T cells to fight lymphoma and editing photoreceptor cells to treat inherited blindness.
Discovery Could Lead to ‘One-Size-Fits-All’ Cancer Treatment
A newly discovered type of killer immune cell suggests the potential for a “universal” cancer therapy a “one-size-fits-all” T cell. The current most widely used T cell treatment, known as chimeric antigen receptor (CAR) T-cell therapy, is personalized to each patient; however, it only targets a limited number of cancers and has not been successful for solid tumors, which make up most cancers. Researchers recently report in Nature Immunology the discovery of T-cells equipped with a new type of T-cell receptor (TCR) that recognize and kill most human cancer types while ignoring healthy cells. Using genome-wide CRISPR–Cas9 screening, Crowther et al established that a TCR recognized and killed most human cancer types via the monomorphic MHC class I-related protein, MR1, while remaining inert to noncancerous cells. These findings offer opportunities for HLA-independent, pan-cancer, pan-population immunotherapies. More research will help to better understand the mechanisms and applications of this exciting finding.
Cytokine Release Syndrome: Current Perspectives
CAR T-cell therapy represents a novel and potentially paradigm-shifting approach to treating cancer. Recent clinical successes have widened the applicability of CD19 CAR T cells for the treatment of relapsed/refractory B-cell NHL, namely tisagenleclucel and axicabtagene ciloleucel. Tisagenleclucel was also approved for relapsed and/or refractory B-ALL up to age 25. CAR T-cell therapy may be associated with unique and potentially life-threatening toxicities, notably cytokine release syndrome (CRS). A better understanding of the pathogenesis of CRS is crucial to ensure proper management. In their open access review, Murthy et al discuss CRS definitions, profiles, risk factors and grading systems and summarize current and novel investigational approaches and therapies for CRS.
Stem Cells and AI: Better Together
 
Cells differ in so many ways it is difficult to predict what cells will do in any given therapeutic scenario. Because there are so many parameters when it comes to living products, there is a chance that a medical therapy will not be effective. Applying an open-source type of artificial intelligence (AI) program called deep neural networks, Shaub et al analyzed images of lab-grown eye tissues. Their program ‘learned’ how to predict cell function in different scenarios and settings from annotated images of cells and could rapidly analyze images of the lab-grown eye tissues to classify the tissues as good or bad. Once trained, an AI program can classify eye tissues more accurately and faster than any human— combining new technology with the basic tool of microscopy
Validation of Simple Prediction Algorithms to Consistently Achieve CD3+ and Post-Selection CD34+ Targets With Leukapheresis
Cellular therapies using engineered T cells, haploidentical transplants, and autologous gene therapy are increasing and require specified CD3+ or high CD34+ doses for subsequent manufacturing, manipulation or selection. Achievement of CD3+ or CD34+ dose targets are important to safety and efficacy of cell therapies. Yoon et al report, in Transfusion, simple, practical, and reliable prediction algorithms for lymphocyte and HPC collections that use conservative facility-specific collection efficiencies, CD34+ selection efficiency, and donor-specific peripheral counts to reliably achieve target CD3+ and CD34+ product doses. The algorithms expand on previously published work useful for collection facilities.

 
 
 
 
EVENTS, OPPORTUNITIES, RESOURCES
NIH Spanish Health Information Portal
Spanish-language health information from across the NIH is available in one place. This site offers free, science-based health information, including dozens of NIH News in Health articles. A feature, called “Ask Carla,” invites questions and comments about finding health info. Visit the website: https://salud.nih.gov
 
Cell Counting Standard Published Through Standard Coordinating Body
A new regenerative medicine standard on evaluating cell counting measurement quality — ISO 20391-2:2019 — is now available. Part 1 (published in January 2018) defines terms and provides general guidance for cell counting measurement processes, while Part 2 (published in August 2019) provides a method for evaluating specific aspects of the quality of a cell counting measurement process. Learn more about how this documentary standard was advanced through an SCB-coordinated project.
New ICD-10-PCS Code for Inpatient T Cell Depletion
A proposal to create a unique ICD-10-Procedure Coding System (PCS) code specific for T cell- depleted stem cell transplants was accepted by the Coordination and Maintenance Committee meeting in April 2019. The American Society for Transplantation and Cellular Therapy (ASTCT, formerly ASBMT) requested the addition of a new ICD-10-PCS code to the existing Administration Table (Table 1) so hospitals will be able to report when T-cell depleted grafts are used for inpatient hematopoietic stem cell (HSC) transplants. Adding this code will allow for more accurate reporting of the specific type of transplant procedure, enable comprehensive analysis of patient outcomes and cost differences by type of graft utilized, and may support advocating for differentiated payment rates for stem cell transplants over time. Information  specific to this coding and the requesting process is summarized on the Miltenyi website.
Cord Blood Connect Online Presentations Available to Public
Open access video presentations from the 2019 Cord Blood Connect International Congress are available for streaming on-demand. The Board of Directors of the Cord Blood Association allocated funding to make the scientific and technical information available to the public. 
AABB Seeking Cellular Therapies Professionals to Join PEP Mentoring Program
AABB is seeking cellular therapies professionals to serve as mentors for the Professional Engagement Program (PEP) mentoring program. The informal, six-month program provides a way for AABB members to share their expertise, expand their professional network and engage in an exchange of ideas. The program pairs experienced AABB members with colleagues who have worked in transfusion medicine, blood banking or cellular therapies for less than 5 years. Mentors and mentees communicate at least once per month by phone. Individuals interested in mentoring can complete an online application. Additional information is available on the volunteer opportunities web page.
AABB Committees Have Openings for 2020-21 Association Year
Committees are vital to the success of AABB. The Association’s committees and volunteers help ensure the information and knowledge it shares with the membership, public and media are timely and accurate. Members who are interested in serving on a committee during the 2020-21 association year may apply by completing the committee volunteer form. AABB will keep the information on file for 3 years. Additionally, all AABB committees seek qualified junior committee members to fill standing positions. To be eligible, applicants must be a current AABB early-career member or an individual member with less than 2 years of membership who has not yet served on an AABB committee, task force or working group. AABB encourages interested members to complete the Committee Volunteer Form, selecting “Junior Committee Member” in the contact information. The application deadline is Feb. 15.

 
 
FOR MEMBERS ONLY
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Members of the AABB Center for Cellular Therapies' subsections meet regularly via teleconference to participate in interactive activities, including developing tools and reference materials, as well as discuss CT topics. For more information visit www.aabbcct.org.

 
The Latest on CT Subsection Activities
The AABB Center for Cellular Therapies encourages members to enroll in subsections to enrich their professional experience connecting with colleagues. An assortment of materials presented on the monthly calls can be found on the CCT projects website.

All subsections met face to face at the AABB 2019 Annual Meeting held in October in San Antonio and are embarking on a new year. 
 
CT-CET: The CT-CET subsection welcomed several speakers, including Indira Guleria, PhD, who spoke on “Stem Cell Tourism” and Amanda Marchiando, PhD, MPH, who spoke on “cGMP Manufacturing for Cell Therapy.”

QRM: The QRM subsection discussed a variety of topics including: the use of artificial intelligence for quality control of stem cell-derived tissues by NIH, NIST researchers and the FDA’s Tissue Reference Group Rapid Inquiry Program (TRIP).

Cord Blood: Discussion encompassed “The CFU Assay: A Biological Tool to Determine Functional Viability, Potency and Stability of CTPs” presented by Jackie Damen, PhD, and “Validation- Let Me Qualify This: How to Feel Good by Knowing Your Equipment Works” presented by subsection Associate Leader, Matthew Wilgo. Other presentations can be viewed on the project web page

Asia Pacific Group (APG): The APG continues its multi-national lineup of guest speakers, who provide worldwide and regional information. Members were sent a survey requesting information on how to optimize their APG experience. Results will be discussed during the February teleconference. Residents of the Asia Pacific region who are interested in being a part of AABB may find information on AABB membership and subsection enrollment online.

Spanish Language Subsection (SLS): The SLS subsection is conducted entirely in Spanish. Presentations can be found on the project web page.