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AABB CellSource - July 2018

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AN UPDATE ON CELL THERAPY NEWS FROM AABB
July 2018
in the news
2018 AABB Annual Meeting Program Guide Available Online
aabbbannercopygood.jpg?r=1531425546774AABB released a detailed program guide for the 2018 AABB Annual Meeting, to be held Oct. 13-16 in Boston. Cellular Therapy (CT) sessions include a wide scope of topics, such as breakthroughs and advances in haploidentical stem cell transplantation; considerations in  CT product characterization and standardization; state of the art chimeric antigen receptor (CAR) T-cell therapies and treatment for non-malignant conditions; xenotransplantation as a source of organs and cells for clinical transplantation and regenerative medicine; novel CT products and functional insights; compliance with current GTP requirements; and CT for sickle cell disease. A pre-meeting CT networking reception will provide a great way to connect and re-connect with CT colleagues. CT enthusiasts will be able to explore the Solve It! Scenarios in CT session where attendees discuss CT challenges and practices. The CT Sizzling Topics luncheon will offer a comfortable setting for discussing the latest advances in MSC practices.
 
Additional information about the meeting, pre-meeting workshops and activities, registration and hotels can be found on the 2018 AABB Annual Meeting website.
Pre-Meeting Workshop to Explore “Cellular Therapies in Trauma and Critical Care”
AABB, in collaboration with the Cellular Therapies in Trauma and Critical Care Conference faculty, will present a preconference workshop, “Cellular Therapies in Trauma and Critical Care,” on Oct. 12 from 8:00 am-5:00 pm just prior to the start of the AABB Annual Meeting in Boston. This one-day workshop will focus on the emerging role of CT in the treatment of trauma and critical care conditions. Speakers will address novel products and their applications, as well as cell manufacturing, regulatory challenges and production needs. The workshop will also include discussions on aligning the needs of those serving in critical care and trauma with those of programs and facilities providing the products, and current clinical trials and lessons learned from designing them. The agenda web page provides topics, scheduled speakers and registration information.
Opportunities Available for CT Section Members to Be a Part of Section Leadership
leadershipcopy.jpg?r=1531425199847AABB’s Cellular Therapies Section welcomes applications from current members of any CT subsection who are interested in seeking election to the CT Section Coordinating Committee, or CTSCC. The CTSCC works collaboratively to lead subsections, set priorities and support CT Section members – providing valuable leadership experience plus the opportunity to network and to enhance industry knowledge. Interested CT Section members should send a message to celltherapy@aabb.org by Aug. 31 stating their intention to seek election, listing subsection areas of interest and describing — in 250 words or less — their relevant experience and potential to contribute to the CT Section. The email should include a photo, as well. To ensure fairness, submissions exceeding the word limit will not be accepted. AABB will acknowledge submissions with an email. Information from qualified candidates will be posted online, and the election will be held by electronic ballot. Results will be announced in October during the CT Section Business Meeting in Boston. AABB strongly encourages international participation.
Application Cycle for 2019 NBF Early-Career Scientific Research Grants Opens
NBFcopychris.png?r=1531429385362The National Blood Foundation (NBF) has begun accepting applications for the early-career Scientific Research Grants Program's 2019 cycle. NBF awards grants to early-career scientists engaged in original research in an area related to blood banking, transfusion medicine, CT or patient blood management. The NBF Scientific Research Grants Review Committee evaluates grant applications on scientific merit, focus and appropriateness to the scope of funding, and likelihood of yielding meaningful data. Additional information about the eligibility criteria, application process and previous recipients is available on the NBF Early-Career Scientific Research Grants Program web page. The application deadline for the 2019 cycle is Dec. 1, 2018. AABB encourages both domestic and international researchers to apply.
Inaugural Spanish-Language eCast to Highlight HLA Typing
ecastspanishcopy.jpg?r=1531425845903AABB will explore HLA in its inaugural Spanish-language eCast, "Métodos para Tipificación Molecular de los Genes HLA." The program, to be held Sept. 27 at 2 pm ET, will feature expert Maria P. Bettinotti, PhD, D(ABHI), FACMG, director of the Immunogenetics Laboratory at the Johns Hopkins University School of Medicine and moderator Celina Montemayor, MD, PhD, staff clinician at the National Institutes of Health Clinical Center's Department of Transfusion Medicine. The program will include case discussions and an open Q&A session to review molecular methods for HLA typing, including underlying principles, advantages and disadvantages, and commonly encountered challenges. The eCast will be available for purchase in the AABB Marketplace following its live broadcast. For more information contact eLearning@aabb.org.
 
AABB invites Spanish-speaking professionals to join the AABB Spanish Language Subsection (SLS). This CT subsection meets the third Wednesday of each month at 10 am ET to discuss assorted topics. Subsection enrollment is a complimentary benefit of AABB Individual Membership.
Interest in Cord Blood Remains High
The U.S. Department of Health and Human Services’ National Health Information Center designated July as National Cord Blood Awareness Month to promote the saving and storing of cord blood and to highlight its potentially life-saving properties.
 
At an international level, Save The Cord Foundation initiated World Cord Blood Day (WCBD) in 2017 to promote the life-giving potential of cord blood worldwide. CellSource_WBD_logo_copy.jpg
 
Building on the success of the 2017 event, organizations, health care professionals and expectant parents are encouraged to participate again this year in activities in the months leading up to the celebration, which falls on Nov. 15. The day will be marked with a free, live virtual conference featuring a variety of guest experts in the field. As an “inspiring partner” in World Cord Blood Day, AABB invites readers to participate in its activities, which include “Cord Blood- Where Are We 30 Years On?, "a complimentary eCast celebrating the 30th anniversary of the first cord blood transplant. Other activities include discussions on Twitter and other social media platforms about cord blood, follower experiences and events, the role or interest of readers in cord blood practice, and education. For information on global events visit www.worldcordbloodday.org.
BARDA Requests Information on “Cellular Therapies and Related Products to Treat Acute Radiation Syndrome”
radiationcopy.png?r=1531426936154The Biomedical Advanced Research and Development Authority (BARDA) within the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services issued a Request for Information (RFI) to identify the readiness of CT and related products for the treatment of acute radiation syndrome. CT provides a potential treatment option to support a patient’s immune system until it has fully recovered from radiation exposure (~21 days). BARDA intends to use responses to this RFI for planning future acquisitions. The Authority seeks pertinent marketplace data on existing availabilities and capabilities to improve its understanding of the current and future marketplace, as well as to enhance its ability to obtain quality services and products economically, and to efficiently and lawfully establish potential vendor source files and listings. Specifically, BARDA is seeking narratives that describe capabilities and address a variety of points, such as primary indications, market penetration, non-clinical and clinical studies, product development plans, regulatory strategy, previous engagements with the Food and Drug Administration, manufacturing process and release testing, cellular characterization, storage conditions and stability testing, as well as relevant opinions and existing solutions. Interested individuals are encouraged to visit FedBizOpps.gov for additional information.
REGULATORY AND GOVERNMENT UPDATE
FDA Releases Six Draft Guidance Documents for Gene Therapies
stemcellscopy.png?r=1531427143860FDA recently released six draft guidance documents for gene therapies. Of particular interest is the draft guidance, “Long Term Follow-Up After Administration of Human Gene Therapy Products.” Scott Gottlieb, MD, released a statement regarding the FDA’s efforts to advance the development of gene therapies, which highlights these draft guidance documents. Comments are due to the Federal Register by October 10th. AABB will be reviewing these draft guidance documents, please send any questions or comments to regulatory@aabb.org. Below is the full list of the six draft guidance documents.
CMS Committee to Review Evidence on National Coverage for CAR T-Cell Therapy
The Centers for Medicare and Medicaid Services (CMS) initiated a national coverage analysis for CAR T-cell therapy for cancers. The analysis will help inform Medicare coverage policies for the therapies. CMS will convene a Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) meeting on Aug. 22 to review the available evidence on the topic.
FDA Updates Guidance on Donor Screening Recommendations for ZIKV in HCT/Ps
zikacopy.png?r=1531427289378The FDA released the updated guidance document, “Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus (ZIKV) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps).” This guidance updates information in the March 2016 guidance by: 1) providing findings from more recent epidemiological studies including impact on public health; 2) reporting new data on the potential for ZIKV transmission; 3) discussing the current status of availability of ZIKV tests; 4) updating sexual contact risk factors; 5) updating when an area is considered to have an increased risk for ZIKV transmission; and 6) providing additional scientific references. The revised guidance supports the continuation of recommendations to screen living donors for ZIKV in HCT/Ps, based on geographic areas with an increased risk for ZIKV. The CDC Blood and Tissue Safety page lists geographic areas with increased risk of ZIKV transmission. The HPC, Apheresis and Marrow Donor History Questionnaire (DHQ) and the HPC, Cord Blood DHQ include the updated sexual contact risk factors.
RESEARCH FOCUS
Modifiers of Mesenchymal Stem Cell Quantity and Quality
mscscopy.png?r=1531427454536Clinical trials involving mesenchymal stem cell (MSC) therapy have variable outcomes. Despite a growing body of knowledge regarding the many ways by which MSCs can exert their therapeutic and reparative effects, the outcomes of MSC-based clinical trials have been highly variable and inconsistent across studies aimed at treating the same indication. Examining proliferation rates, cytokine secretion profiles and differentiation capability of bone marrow- and adipose tissue- derived MSCs, Russell et al report in Transfusion that MSC physiology is significantly influenced by donor variability and tissue of origin, information that should be considered when designing clinical trials.
Development of a Proof of Principle for Universal Neutralization of Antibiotics in Cord Blood Byproducts Used for Sterility Testing
The fact that bacterial contamination of cord blood (CB) represents a safety risk for transplantation patients highlights the importance of sterility testing. Accuracy of testing results may be affected in collections from donors who have undergone antibiotic treatment; therefore, neutralization of antimicrobials used in CB units is recommended for an optimal sterility testing process to minimize false-negative results. Kou et al report in Transfusion the development of an in-house protocol at Canadian Blood Services for antibiotic neutralization in CB used for sterility testing and discuss its benefits and limitations.
Flashback Highlights the Consistency and Safety of Established HPC Collections
In 1997, the NIH Clinical Center produced an educational video for patients and blood donor volunteers who considered undergoing hematopoietic progenitor cell (HPC) collection by peripheral blood apheresis. Over time, little has changed in the basic information on this procedure that enables potentially life-saving transplantations. Readers are encouraged to view the video first published in Transfusion by Flegel et al: “Flashback 1997: collection of hematopoietic progenitor cells by peripheral blood apheresis after stimulation with granulocyte-colony-stimulating factor to reflect on any changes.”
What Happens When the Immune System Goes Rogue?
chancecopy.png?r=1531427634992When the immune system functions well, it activates a variety of processes to protect against deadly threats, such as invading microbes and cellular disease. However, what happens when the immune system goes rogue and attacks the body it is meant to defend? This is the essence of autoimmune disease — a person's immune system mistakenly attacking healthy cells. Approximately 10% of the population suffers from some form of autoimmune disorder. To understand more about the underlying mechanisms, watch immunologist Betty Diamond, MD, as she describes her patient-centered studies that reveal valuable new insights and empower patients to play a leading role in the research into autoimmune diseases.
Stem Cell-Based Eye Repair: A Review of Current Clinical and Preclinical Studies
eyecopy.png?r=1531427847339
Stern et al. review the status of clinical and preclinical studies for stem cell-based repair, covering key eye tissues from front to back, from cornea to retina, and including bioengineering approaches that advance cell product manufacturing in this CellPress video abstract.
EVENTS, OPPORTUNITIES, RESOURCES
AABB eCasts
CELLSOURCE_ecastsimage.jpgAABB offers educational programs via eCasts — live, online interactive programs covering topics in transfusion medicine, cellular therapies and patient blood management. Registration is available for individuals and groups. Institutions can host eCasts for employees at one or more sites.  On-demand recordings of eCast sessions are available for those unable to attend a live eCast.
 
Upcoming CT eCasts:
 
 
Sept 6: Cord Blood - Where Are We 30 Years On? (Anniversary of the First Transplant (1988)) - This complimentary eCast will be a part of the celebration of World Cord Blood Day. In order to attend this program, please register through the GoToWebinar link.
 
 
Cellular Therapies Certificate Program Provides CME Opportunity for CT Professionals 
CELLSOURCE_CTCERTIFICATEprogram.jpgThe 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 fill out a program evaluation form will receive a certificate of completion. The program also provides continuing education credits (CMEs).
A Unifying View of the Human Induced Pluripotent Stem Cells
ipscopy.png?r=1531428850120The Allen Integrated Cell is a predictive, 3D model of human induced pluripotent stem cell (hiPSC) organization. It provides a realistic, data-driven 3D visualization of a living hiPSC in its pluripotent state. The visualization simultaneously shows the many molecular machines and structures (organelles) inside the cell. This integrated organization drives the cell’s basic functions, and these models provide a baseline for new models of different cell types, disease, drug responses, and cellular environments.
 
The Allen Integrated Cell unites two technologies to improve understanding of how hiPSCs vary in both shape and organization. One is a deterministic model, which shows the organization of organelles in particular individual cells, and the other model is probabilistic — showing likely shapes and locations for organelles in any cell. One can interactively explore many examples of their cells — including some that are preparing to divide(!) — in both the 3D deterministic and probabilistic views in the Allen Integrated Cell. Click on the Visual Guide to Human Cells to experience cell functions and structures. This site is best viewed in Chrome, Safari or Firefox browsers.
PODCAST: Cord Blood — Tips from the Delivery Room
In this podcast, Kim Petrella, RNC-OB, MSN, provides facts about umbilical cord blood banking and current and potential therapeutic uses of cord blood - key information that can be shared with expectant parents considering cord blood collection. Through a Q&A interview format with a moderator, Kim also discusses best cord blood collection practices to ensure high-volume and high-quality cord blood units (audio only, works best in Firefox or Chrome).
 
The link to this NMDP podcast as well as other CB information is available through the CB FAQs found on the AABB CCT website.
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
Asia Pacific Group (APG): This subsection accommodates members in the Asia/Pacific region on the second Wednesday of each month at 0400 UTC (universal coordinated time) to discuss a variety of topics related to cellular therapies. Yen-Michael S. Hsu, MD, PhD, David Stroncek, MD, and Arun Prasath, MS, lead the discussions. 
Both from the Tata Memorial Hospital-ACTREC (Mumbai, Maharashtra, India), Anisha Navkudkar, MD, presented “Adoptive Immunotherapy,” and Minal Poojary, MD, presented “Transfusion-Associated Graft vs Host Disease.” Li Chen, PhD, introduced the group to the “Biological Role of Exosomes in Liver Fibrosis.” APG members are encouraged to attend upcoming talks that will cover "Stem Cell Banking in Yunnan Province" and "Advances in Cell Therapy and Considerations for Blood Centers."
 
Regulatory Affairs: This subsection, led by Ljiljana Vasovic, MD, and Olive Sturtevant, MHP, MT(ASCP)SBB,SLS, CQA(ASQ), discussed a range of issues including Right to Try and its impact.
 
CT Management: This group, led by subsection leaders Suzanne Dworsky, MBA, MT(ASCP), and Brian Jones, SBB(ASCP), revisited a popular topic — personnel management. Participants shared their experiences and advice.
 
Novel Therapies and CT Product Development: This subsection, led by Magali Fontaine, MD, PhD, and Richard Schaefer, MD, welcomed Christof Westenfelder, MD, who presented “Durable Control of Autoimmune Diabetes in Mice Achieved by Intraperitoneal Transplantation of ‘Neo-Islets:’ 3D Aggregates of Allogeneic Islet and Mesenchymal Stem Cells.”
 
CT Quality Operations: Ed Brindle, MSc, MLT(CMLTO), and Deb Sesok-Pizzini, MD, MBA, discussed their benchmarking project on environmental monitoring as well as upcoming AABB activities.
 
CT Product Collection and Clinical Practices: Subsection leaders Tom Spitzer, MD, and Jay Raval, MD, discussed a variety of topics including practices for infusing large volumes of cryopreserved products, hetastarch for red cell depletion and ‘spotlighted’ articles, such as “Adverse Prognostic Factors for Morbidity and Mortality During Peripheral Blood Stem Cell Mobilization in Patients with Light Chain Amyloidosis" as well as a long-term follow-up report on plerixafor plus G-CSF for patients with non-Hodgkin lymphoma and multiple myeloma.
 
CT Product Manufacturing and Testing: Ronit Slotky, PhD, MSc, and Mike Halpenny, MLT(CMLTO), discussed assorted challenges. Guest speaker, Kevin Shoulars, PhD, presented “Development and Validation of a Rapid Aldehyde Dehydrogenase Bright-Based, Cord Blood Potency Assay.”
 
Cord Blood Subsection: Subsection leaders Salem Akel, PhD, and Gwen Epstein, BSC, RT, discussed a variety of topics  with guest Cade Hildreth, MS, who updated the group on cord blood issues and invited discussion on current trends and activities.
 
Spanish Language Subsection (SLS): AABB encourages copy_CELLSOURCE_SLS.jpgSpanish-speaking members to join the SLS. Celina Montemayor, MD, PhD, moderates this subsection, which is conducted entirely in Spanish. The SLS projects page showcases content that has been presented to the subsection.
 
 
 
 
Editor: Christina M. Celluzzi
Contributors: Kathy Loper and Jessica Yozwiak
 
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