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AABB CellSource - January 2018

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AN UPDATE ON CELL THERAPY NEWS FROM AABB
January 2018
in the news
Registration Opens for 16th International Cord Blood Symposium
CELLSOURCE_ICBS50.jpgThe International Cord Blood Symposium (ICBS) is the premier event for the cord blood, cord tissue and regenerative medicine industries. The meeting brings together top experts in cord blood banking and research from throughout the world. Early registration is open with special pricing for AABB members. Those interested can sign up to be notified as more information becomes available.
Submissions of abstracts will be accepted until March 29. Those interested in submitting an abstract should review the guidelines
World Cord Blood Day Celebration Deemed a ‘Hit’- Q&A From Live Virtual Conference Now Available
CELLSOURCE_WCBDlogo.jpgThe value of cord blood was celebrated throughout 2017, culminating in a free, live virtual  conference marking World Cord Blood Day (WCBD) on Nov 15. WCBD, an initiative of Save the Cord Foundation, attracted international attention and drew more than 2,000 participants in 58 countries. More than 100 organizations were involved in a variety of events to celebrate WCBD. An estimated 29% of attendees were members of the general public and 71% were health professionals who joined in to hear presentations on topics ranging from the history of cord blood to potential cord blood therapies to treat type 1 diabetes, spinal cord injuries, autism and cerebral palsy. Participants submitted questions to the expert panel of speakers. The questions and responses from an expert panel have been posted on the WCBD website. WCBD is planned as an annual event going forward. The AABB Center for Cellular Therapies encourages members to mark their calendars for the 2018 WCBD to be held on Nov. 15.
AABB Awards Free ICBS Registration to Participant Who Shares Story of Inspiration
CELLSOURCE_Instagram(1).jpgAs an “inspiring partner” in World Cord Blood Day, AABB celebrated cord blood’s potential in a variety of ways. The association provided a forum on FacebookInstagram and Twitter where individuals could discuss their experience working in the field and describe their role or interest in cord blood practice and education. AABB also offered a free registration to the meeting, to be held on June 14-16, to an individual who described a compelling reason for becoming interested in cord blood. Maria Hernandez, known as “glamreaper” on Instagram, won the giveaway for sharing the story of her mother, life’s timing and the rewards of being a cord blood collector. Read her post on Instagram.
ICCBBA Releases ISBT 128 Compliance Audit Tool for Use with CT Products
CELLSOURCE_AUDITISBT128.jpgICCBA released an audit tool developed to help determine compliance with the ISBT 128 Standard; the tool is intended for use by any licensed CT facility in the world. The tool was developed with input received from industry experts and the international Cellular Therapy Coding and Labeling Advisory Group, which is co-sponsored by ICCBBA, AABB, the Foundation for the Accreditation of Cellular Therapy, the International Society for Cellular Therapy and others. The tool enables users to scan and manually enter product information and add notes during the audit. It includes an interactive user interface, links to helpful documents/databases and a running tally to aid in audit “scoring.”
 
It should be noted that the tool does not take into consideration requirements from national regulatory bodies and may not cover all labeling requirements of CT accreditation bodies. Additionally, the tool does not ensure that proper Product Codes have been selected. AABB notes that this tool may be used in future accreditation audits to verify compliance with the ISBT 128 labeling standard and encourages accredited users to contact their accreditation body to find out if and how the tool will be used. Feedback on the CT audit tool will be used in creating similar audit tools for other subject areas. For more information visit ICCBBA.
 
RAND Releases Report on Challenges to the Sustainability of the US Public Cord Blood System; AABB Posts Q&A with Cord Blood Expert
RAND produced a report on the United States public cord blood system to help fill gaps in knowledge by describing the existing public cord blood bank (CBB) system. The report assesses current trends and economic relationships from the perspective of key stakeholders in the public CBB system, and provides recommendations to improve the economic sustainability of the system. Karen Ballen, MD, chair of the National Marrow Donor Program’s cord blood advisory committee, agreed to answer a few questions on the report. AABB posted her comments on its website.
Perinatal Stem Cell Society Meeting Open for Registration
Perinatal stem cell sources include amnion, amniotic fluid, cord blood, cord tissue, and placental blood and tissue. The Perinatal Stem Cell Society (PSCS), Inc. is a non-profit organization founded on the principle that stem cells from these perinatal sources contain enormous, untapped life potential to treat a variety of diseases and disorders. The 4th Annual PSCS Congress will be held Mar. 1-2 in Salt Lake City, UT. Registration is open.
AABB Accepting 2018, 2019 Memorial Award Nominations Until Jan. 26
The deadline to submit nominations for 2018 and 2019 AABB memorial awards is Jan. 26. The awards honor those who have made significant contributions to the fields of transfusion medicine, cellular therapies and patient blood management by recognizing achievements in administration, immunohematology, quality and innovative research, as well as overall outstanding service to the field. Awards will be presented during the 2018 AABB Annual Meeting — to be held Oct. 13-16 in Boston — or during the 2019 AABB Annual Meeting in San Antonio. AABB encourages members to nominate a deserving peer for a memorial award.
REGULATORY AND GOVERNMENT UPDATE
CDC Zika Virus Tracking Tool Update Prompts Revisions to Donor History Questionnaires for HPC and Cord Blood
The AABB Interorganizational Donor History Questionnaire (DHQ) – Hematopoietic Progenitor Cell (HPC) Task Force updated the Cord Blood DHQ and the HPC, Apheresis and Marrow DHQ. This was done to reflect changes to the Centers for Disease Control and Prevention’s tool for Zika virus tracking. The DHQ update included inserting the CDC web page name “blood and tissue safety” with the appropriate link in the ZIKV Appendix, User Instructions and Flow Charts. AABB encourages those with comments or questions to contact regulatory@aabb.org.
The FDA document “Important Information for Human Cell, Tissue, and Cellular and Tissue-Based Product (HCT/P) Establishments Regarding Zika Virus Transmission Risk in the World” describes how CDC previously reported areas outside of the U.S. with active Zika virus transmission risk via travel notice start and end dates. CDC will now identify Zika risk areas in other countries and territories using a world map. The document also discusses references to use when screening HCT/P donors and other considerations.
FDA Releases Comprehensive Regenerative Medicine Policy Framework, Including Guidance on Minimal Manipulation and Homologous Use
FDA announced a comprehensive policy framework for the development and oversight of regenerative medicine products, including novel cellular therapies, on Nov. 16. The framework, which comprises four guidance documents — two final and two draft guidances — fulfills provisions in the 21st Century Cures Act and builds upon FDA’s existing risk-based regulatory approach.
 
The two final guidances convey FDA’s interpretation of the risk-based criteria used by manufacturers to determine whether a product is subject to the agency’s premarket review. The first final guidance is titled “Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception,” and the second is “Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use.”
 
FDA intends for the two draft guidance documents to provide important information to help spur development and access to innovative regenerative therapies. The first draft guidance is titled “Evaluation of Devices Used with Regenerative Medicine Advanced Therapies.” The second draft guidance is titled “Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.” Both draft guidance documents include information on FDA’s Regenerative Medicine Advanced Therapy Designation (RMAT).
Centers for Medicare & Medicaid Services Finalizes Medicare Hospital Outpatient Payment Policies for 2018
The Centers for Medicare & Medicaid Services (CMS) published a final rule updating Medicare payment rates and policies under the hospital outpatient prospective payment system (OPPS) for calendar year 2018 in the Federal Register on Nov. 13, 2017. In general, the final rule increases payment rates under the OPPS by 1.35%. The payment rates for blood and blood products will experience a net reduction of 1%, which reflects decreased payments for certain products and increases for others. In contrast, the payment rates for transfusion, apheresis and stem cell procedures will undergo a net increase of 7%, and the rates for transfusion laboratory services will increase by a net payment of 22%. AABB’s summary of the final OPPS is available online.
RESEARCH FOCUS
‘Fake News’ Portrayals of Stem Cells and Stem Cell Research
The spread of misinformation, including “fake news,” has had a significant impact on recent discourse surrounding health. Access to, and proper understanding of, accurate health information has been shown to improve health outcomes. Due to confirmation bias, individuals who distrust a health product or service often seek out validating information. “Fake news” can support unverified claims in the absence of real evidence. Belief in health misinformation can have an adverse effect on health behaviors and outcomes. In a recent study, Caulfield et al examined how stem cells and stem cell research are portrayed on websites deemed to be purveyors of distorted and dubious information. The researchers compiled and analyzed data from 224 articles from 2015 and 2016. The articles were identified by searching with the keywords ‘stem cell(s)’ on a list of websites flagged for containing either “fake” or “junk science” news. The researchers found articles with various exaggerated claims — both positive and negative — about stem cells and stem cell science, health- and science-related conspiracy theories, and statements promoting fear and mistrust of conventional medicine. Their findings demonstrate the existence of organized misinformation networks, which may lead the public away from accurate information and facilitate a polarization of public discourse.
Inflammation: A Key Regulator of Hematopoietic Stem Cell Fate in Health and Disease
Hematopoietic stem cells (HSCs) are responsible for lifelong production of blood cells. At the same time, they must respond rapidly to acute needs, such as infection or injury. Significant interest has emerged on how inflammation regulates the fate of HSCs and how it effects the long-term functionality of HSCs and the blood system. In a recent article published in Blood, Eric Pietras details recent advances and unanswered questions at the intersection between inflammation and HSC biology in the contexts of development, aging and hematological malignancy.
Amniotic Fluid Contains a Wealth of Stem Cells That Can Be Safely and Non-Invasively Extracted
CELLSOURCE_amnioticfluid_video.jpgResearchers from Lund University in Sweden have developed a noninvasive method of extracting a large number of mesenchymal stromal cells from amniotic fluid that would otherwise be considered waste. The fluid is collected in a sterile container created by a 3-D printer using bio-inert plastics. It forms a seal with the fetal cavity, allowing the gentle collection of up to a liter of amniotic fluid. The fluid is then transported to the lab, where it is purified through filtering with a gauze filter and a 100-micrometer cell strainer. Stem cells are separated by centrifugation and grown in cell culture. The researchers suggest this may be a good way to provide cells for mesenchymal stem cell-based cell therapy and regenerative medicine applications. This short video illustrates the procedure.
Researchers Use CRISPR to Activate Genes
Current genome-editing systems generally rely on inducing DNA double-strandCELLSOURCE_CRISPRvideo.jpg breaks (DSBs). This may limit their utility in clinical therapies, as unwanted mutations caused by DSBs can have deleterious effects. Investigators recently repurposed the CRISPR/Cas9 system to enable target gene activation, allowing regulation of endogenous gene expression without creating DSBs. A video demonstrates how Salk scientists used a non-permanent epigenetic approach to turn genes on without altering DNA. The team is exploring if this method can be used to fight disease, demonstrating the therapeutic potential of Cas9-based epigenetic gene activation in mouse models of type I diabetes, acute kidney injury and muscular dystrophy.
The Science of Cells That Never Get Old: Elizabeth’s Blackburn’s Groundbreaking Research on Telomerase
CELLSOURCE_telomerasevideo.jpgWhat makes our bodies age? What makes our skin wrinkle, our hair turn white, our immune systems weaken? Biologist Elizabeth Blackburn shared the 2009 Nobel Prize in Physiology/Medicine for her work on aging. Her research resulted in the discovery of telomerase, an enzyme that replenishes the caps at the end of chromosomes that break down when cells divide. Blackburn's groundbreaking research — including how we might have more control over aging than previously understood — is described in this video.
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, 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.
 
 
CT eCasts available in 2018 include:
Jan. 23: ISBT 128 Audit Tool for Cellular Therapy (#18EL-309) (mandatory for CT assessors)
2017 AABB Annual Meeting On-Demand CT Sessions Available as a Separate Product
To give individuals the opportunity to earn continuing education credits in CT topics, AABB is offering for purchase a bundle of on-demand presentations for education sessions from the 2017 AABB Annual Meeting. Registration provides access for one individual log-in. Continuing education credit is offered only for the individual that purchases this on-demand program. Once registered, program content is available for use through Dec. 31, 2019. Session and purchase information is provided on the AABB website.
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).
Three-Year AABB Memberships Available
CELLSOURCE_AABBlogo.jpgThose who are interested in joining AABB now have the option to purchase a three-year (best value) membership. Current members will have that opportunity at their next membership renewal.
Easy Access to Resources for AABB Members

The AABB Member Resources web page provides links to relevant news sources, educational programs, advocacy updates, networking and volunteering opportunities, and more. Visit the web page to discover new ways to build a network of colleagues, investigate opportunities for professional development and keep up with the latest advances in transfusion medicine, cellular therapies and patient blood management.
ICCBBA Website Provides Resources on ISBT Labeling
As the requirement to comply with the ISBT 128 standard is nearing on July 1, 2018, users may find it useful to see what types of information appear on an ISBT 128 label. Examples of labels provided by other ISBT 128 users are available on the ISBT 128 website. The ISBT 128 for cellular therapy booklet is also a useful resource.
Information on Active Zika Virus Transmission Areas From the CDC
The CDC’s blood and tissue safety website contains information on the geographic areas of active Zika virus transmission and areas of risk of Zika virus. The information on these websites changes as the Zika Virus areas of transmission change.
FDA Video Explains Gene Therapy Inside Out
CELLSOURCE_FDAgenetherapy_videoimage.jpgGene therapy is the process of replacing defective genes with healthy ones, adding new genes to help the body fight or treat disease, or deactivating problem genes. It holds the promise to transform medicine and create options for patients who are living with difficult, and even incurable, diseases. FDA has produced this short video to show how this innovative therapy works.
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. David Stroncek, MD, Arun Prasath, MS, and Yen-Michael S. Hsu, MD, PhD, lead the discussions. Steven Highfill, PhD, presented “Current Progress and Future Prospects of CAR T-Cell Therapy.” Prasath presented a new cord blood banking model, “Crossover Banking for the Singapore Community.”
 
Regulatory Affairs: This subsection, led by Ljiljana Vasovic, MD, and Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ), discussed several FDA guidances including a Review of FDA Regenerative Medicine Framework Release. The group is working on proposals for education sessions for the 2018 AABB Annual Meeting.
 
CT Management: This group, led by subsection leaders Suzanne Dworsky, MBA, MT(ASCP), and Brian Jones, SBB(ASCP), discussed personnel management covering position determination, descriptions, interviewing, compensation rates, hiring, and orientation and training.
 
Novel Therapies and CT Product Development: This subsection, led by Magali Fontaine, MD, PhD, and Richard Schaefer, MD, discussed future activities surrounding mesenchymal stromal cells (MSCs). The group is developing proposals for education sessions for the 2018 AABB Annual Meeting.
 
CT Quality Operations: Ed Brindle, MSc, MLT(CMLTO), and Deb Sesok-Pizzini, MD, MBA, led the group in discussion on challenges in the field. The group is working on proposals for education sessions for the 2018 AABB Annual Meeting.
 
CT Product Collection and Clinical Practices: Subsection leaders Tom Spitzer, MD, and Jay Raval, MD, discussed challenges in the field such as recurrent bacterial contamination of PBSC products after central line insertion and recent articles in the spotlight. The group is working on proposals for education sessions for the 2018 AABB Annual Meeting.
 
CT Product Manufacturing and Testing: Ronit Slotky, PhD, MSc, and Yen-Michael S. Hsu, MD, PhD, worked with the group to develop proposals for education sessions for the 2018 AABB Annual Meeting. Slotky presented her “AABB Experience.”
 
Cord Blood Subsection: Subsection leaders Salem Akel, PhD, and Gwen Epstein, BSC, RT, discussed challenges in the field, the recent RAND report on “Challenges to the Sustainability of the US Public Cord Blood System,” events held to celebrate World Cord Blood Day and how the group could get involved in supporting cord blood. The group is producing proposals for education sessions for the 2018 AABB Annual Meeting.
 
Spanish Language Subsection (SLS): copy_CELLSOURCE_SLS.jpgSpanish-speaking members are encouraged 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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