| AN UPDATE ON CELL THERAPY NEWS FROM AABB |
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in the news | Cellular Therapy Sessions and Networking Opportunities Abound at 2018 AABB Annual Meeting |
 A variety of sessions developed for cellular therapy (CT) professionals are on the
program for attendees of the 2018 AABB Annual Meeting, to be held Oct. 13-16 in Boston. The meeting includes popular interorganizational educational sessions and networking events. AABB has partnered with TERMIS-AM to present “ Regenerative Medicine Therapies for the Clinic” and NMDP to hold a session on “ Challenges and Opportunities in HCT Donation.” Members of AABB’s CT subsections worked together to create an assortment of real-world scenarios for discussion at
Solve It! Scenarios in Cellular Therapies, a roundtable networking event where colleagues collaborate to find solutions to challenges in the CT field. Attendees are encouraged to visit the
AABB meeting website and to download the 2018 AABB Annual Meeting
app. | New!! Dana Farber Cancer Institute’s Cell Manipulation Facility Open House for Annual Meeting Attendees | Cellular therapy professionals attending the AABB Annual Meeting are invited to an open house event including a facility tour and dinner on Sunday, Oct. 14, from 6:00pm -8:30pm. Registration is required, and attendance is limited so
sign up today! RSVP by Oct. 8. Transportation will be provided, and the event is offered at no cost. Additional details will be available at booth 439 in the AABB Exhibit Hall. | Pre-Meeting Workshop Will Explore “Cellular Therapies in Trauma and Critical Care” |
 Trauma is a leading cause of death in both military and civilian populations worldwide. Although medical advances have improved the overall morbidity and mortality often associated with trauma, additional research and innovative advancements in therapeutic interventions are still needed to optimize patient outcomes. Cell-based therapies present a novel opportunity to improve trauma and critical care at both the acute and chronic phases that often follow injury. AABB, in collaboration with the Cellular Therapies in Trauma and Critical Care Conference faculty, will present a pre-meeting workshop, “Cellular Therapies in Trauma and Critical Care,” the day before the 2018 AABB Annual Meeting begins in Boston on Oct. 12, from 8:00 am - 5:00 pm. This one-day workshop will focus on the emerging role of CT in treating trauma and critical care conditions. The workshop will also include discussions on aligning the needs of health care providers serving patients receiving critical and trauma care with those running programs and facilities providing the products, and those performing clinical trials and the lessons they learned from designing them. The
agenda web page provides topics, scheduled speakers and registration information. | | Comment Period for Proposed 9th Edition of CT Standards Closing Soon |
 The proposed 9th edition of Standards for Cellular Therapy Services is available for public
comment. A
summary of significant changes is available to facilitate review of the proposed Standards. After the comment period ends, the CT Standards Committee will meet to review all submissions. The 9th edition will go into effect on July 1, 2019. | | Complimentary Cord Blood eCast Available From AABB for Upcoming World Cord Blood Day Celebrations | World Cord Blood Day (WCBD) will be celebrated on Nov. 15. As part of its year-long activities  as an inspiring partner, AABB offers a complimentary eCast, “Cord Blood-Where Are We 30 Years On?” This eCast took place in September and is now
available On-Demand. Other AABB activities leading up to WCBD include discussions on
Twitter and other social media platforms about experiences with cord blood. | First AABB Spanish Language eCast Available On-Demand |
 AABB premiered its first Spanish-language eCast, “Métodos para Tipificación Molecular de los Genes HLA,” on Sept. 27. The eCast is available
On-Demand. Our Spanish-speaking readers are encouraged to explore this content and provide feedback to
eLearning@aabb.org, which will be important to expanding this type of programming. 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. | |
REGULATORY AND GOVERNMENT UPDATE | Revised DHQ for HPC, Apheresis and Marrow and Cord Blood Now Available | | NIH, FDA Announce Plans to Streamline Oversight of Human Gene Therapies |
 Officials at the National Institutes of Health (NIH) and United States Food and Drug Administration recently announced plans to streamline oversight of human gene therapies in a New England Journal of Medicine perspective. NIH Director Francis S. Collins, MD, PhD, and FDA Commissioner Scott Gottlieb, MD, propose eliminating duplicative reporting requirements for gene-therapy trials. For example, it would limit the role of NIH and the Recombinant DNA Advisory Committee (RAC) in assessing gene-therapy protocols and reviewing their safety. Additionally, the agency will revise the responsibilities of Institutional Biosafety Committees to align their review of human gene-therapy protocols with other research areas subject to NIH Guidelines. These proposed changes, Collins and Gottlieb note, will allow the RAC to return to its original goal of advising the NIH director on the scientific, safety and ethical issues associated with emerging biotechnology. |
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| FDA Extends Comment Period for Draft Guidance Documents on Development of Human Gene Therapy Products | FDA
announced the agency will extend the comment period for the six draft guidance documents about
the development of human gene therapy products from the July 12 Federal Register in response to requests for an extension to allow interested individuals additional time to submit comments and any new information. Comments are due by Dec. 10 to the
Federal Register. | FDA Warns About Increased Risk of Cancer Relapse With Long-Term Use of Azithromycin After Donor Stem Cell Transplant | The U.S. FDA is
warning that the antibiotic azithromycin (Zithromax or Zmax) should not be given long-term to prevent a certain inflammatory lung condition in patients with cancers of the blood or lymph nodes who undergo a donor stem cell transplant. Results of a clinical trial found an increased rate of relapse in cancers affecting the blood and lymph nodes, including death, in these patients. Additional data are being reviewed. Conclusions and recommendations will be communicated when the review has been completed. The serious lung condition for which long-term azithromycin was being studied called bronchiolitis obliterans syndrome is caused by inflammation and scarring in the airways of the lungs, resulting in severe shortness of breath and dry cough. Cancer patients who undergo stem cell transplants from donors are at increased risk for bronchiolitis obliterans syndrome. Pfizer, the manufacturer of brand name azithromycin, is providing a
Dear Healthcare Provider letter on this safety issue to health care professionals who care for patients undergoing donor stem cell transplants. | |
RESEARCH FOCUS | Current Practices for Viability Testing of Cryopreserved Cord Blood Products: An International Survey by the Cellular Therapy Team Of The Biomedical Excellence For Safer Transfusion (BEST) Collaborative |
 Viability testing is a common practice in laboratories. The goal of a BEST study by
Takenashi et al. was to ascertain current laboratory practices internationally for performing viability testing for cryopreserved cord blood (CB) products and to glean information about how to standardize the method to improve interlaboratory reproducibility. The researchers designed a survey to evaluate current laboratory practices for viability testing and distributed it internationally. The questions covered sampling and testing methods, responses to unexpected results, and the rating of the reliability of the CB quality tests, together with expectations for standardization. Overall, responses indicated that various stains were used among the laboratories, and when multiple sites used the same viability stain, the methods differed. The majority of the respondents favored standardizing the viability testing methods. Flow cytometry with a 7‐AAD dye was suggested as a first step toward standardization. |
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| Effect of Platelet-Rich Plasma on Chondrogenic Differentiation of Adipose- and Bone Marrow-Derived Mesenchymal Stem Cells | Platelet-rich plasma (PRP) is an autologous, growth factor-rich biologic preparation that has received increasing attention as a therapeutic adjunct to treat degenerative joint diseases. There is evidence suggesting that PRP acts by promoting stem cell proliferation and tissue healing. Liou et al. have examined the effect of PRP treatment on chondrogenic differentiation of adult human MSCs derived from infrapatellar fat pad-adipose stem cells (IFP-ASCs) and bone marrow (BM-MSCs). Both cell types were placed in high-density pellet culture and hydrogel-encapsulated culture under chondrogenic conditions. The results showed that PRP did not improve IFP-ASC or BM-MSC chondrogenesis. In general, chondrogenesis was inhibited with increasing PRP concentrations and duration of exposure, based on histological, biochemical and gene expression analyses. Taken together, these findings suggest that although PRP is believed to be beneficial for pain relief and joint function improvement, its mechanism of action is unlikely to directly involve enhancing MSC-mediated hyaline cartilage formation. | Staying ‘Chill’ Even When Disaster Strikes; NIST Cryogenic Teams Working to Protect Valuable Specimens in Biorepositories | Technically, there is no universal definition of a repository, although the International Society for Biological and Environmental Repositories (ISBER) hopes to have one soon. For five years, members of ISBER and other organizations have been developing an ISO standard that would help formalize the term and provide appropriate best practices for running such a facility. The resulting
ISBER Best Practices are now freely available online to benefit the entire scientific community. Collaborations among professionals to discuss and develop best practices have been key. The National Institutes of Standards and Technology (NIST) illustrates the importance of a harmonized standard via their
description of the rare specimen collection storage at the Hollings Marine Lab located in Charleston, South Carolina. | |
EVENTS, OPPORTUNITIES, RESOURCES | |
 AABB offers educational programs via
eCasts.
On-Demand recordings of AABB sessions, including CT programs, are available for those unable to attend a live eCast. eCasts for 2019 will soon be posted on the AABB eLearning webpage. |
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| Abstract Presentations from the 2018 AABB Annual Meeting Available in Transfusion Supplement | Interested readers can read the abstracts from the Abstract Presentations sessions to be highlighted during the 2018 AABB Annual Meeting Boston, Mass., October 13–16, in a special supplement to the September issue of
Transfusion journal. | | Video Details Essentials of Delayed Cord Blood Clamping | | Human Cell Atlas Aims to Map Every Cell in the Human Body | A project known as the
Human Cell Atlas (HCA) Consortium, formed in 2016, is seeking to create an index of every unique type of cell in the body. Researchers hope this catalog will provide new insights into how the body works and how it can ward off disease. The global effort, which currently includes 500 scientists, has received $200 million in funding from the National Institutes of Health. Given the experiences with the National Human Genome Research Institute’s Human Genome Project, researchers acknowledge that cataloging every cell will be time-consuming and may not lead to immediate breakthroughs; however, they are optimistic that the HCA will prove invaluable in disease research. A complimentary white paper available for
download provides an overview of the effort. It includes the framework for the first draft of the atlas; descriptions of the technology and data analysis tools available to build the atlas; an introduction to the Data Coordination Platform that will host the data for researchers worldwide; and an in-depth description of the biological systems the Consortium plans to explore and map. The paper also details the organization and governance of the HCA consortium and its relationships with the public — including ethical considerations regarding organ and tissue donors — and to funding support. | | Cellular Therapies Certificate Program Offers Distinctive Learning Opportunity |
 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 that cover 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 helps students stand out among peers with expanded knowledge and provides the opportunity to earn continuing education credits (CMEs). | |
FOR MEMBERS ONLY |
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 led by
Yen-Michael Hsu, MD, PhD, and
Arun Prasath, MS, 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 CT.
Li Chen, PhD, presented “Biological Role of Exosomes in Liver Fibrosis, and
Sandhya Panch, MD, MPH, presented “ Advances in Gene 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 US FDA Guidance documents on gene therapy. The subsection also welcomed guest speaker
Rob Tressler, PhD, who presented “ Blood Center Considerations for Product Collections, Processing and Distribution.”
CT Management: This group, led by subsection leaders
Suzanne Dworsky, MBA, MT(ASCP), and
Brian Jones, SBB(ASCP), developed scenarios for the AABB Annual Meeting and identified management issues for future discussion.
CT Quality Operations:
Ed Brindle, MSc, MLT(CMLTO), and
Deb Sesok-Pizzini, MD, MBA, discussed their survey and prepared for the AABB Annual Meeting.
CT Product Collection and Clinical Practices: Subsection leaders
Tom Spitzer, MD, and
Jay Raval, MD, discussed a variety of challenges surrounding sample contamination and DMSO exposure time of thawed samples. They also held several journal clubs on topics such as apheresis volumes and the associated reduction in relapse risk and increased survival. In addition, the group examined a long-term follow-up report of bone marrow transplant in patients with non-Hodgkin lymphoma.
CT Product Manufacturing and Testing:
Ronit Slotky, PhD, MSc, and
Mike Halpenny, MMLT(CMLTO), conducted a journal club discussion on cryopreservation and related adverse events. Halpenny presented “Conversations on Post-Thaw Testing: Testing Methods, Standardization, Challenges and Regulations/Standards.”
Cord Blood Subsection: Subsection leaders
Salem Akel, PhD, and
Gwen Epstein, BSC, RT, welcomed Terri Tibbot, MS, CTBS to share experiences related to collecting cord blood and other perinatal tissues. |
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Editor: Christina M. Celluzzi
Contributors: Kathy Loper and Jessica Yozwiak
AABB Center for Cellular Therapies
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