AABB CellSource - July 2015

 
AN UPDATE ON CELL THERAPY NEWS FROM AABB
July 2015

IN THE NEWS

AABB Annual Meeting Registration Opens

Registration for the 2015 AABB Annual Meeting, to be held Oct. 24-27 in Anaheim, Calif., is now open. This four-day event offers participants access to educational sessions on the latest research; continuing education credits; networking opportunities; social events; and exhibits featuring innovative products and services.There will be several pre-convention workshops including a workshop on mesenchymal stromal cells. AABB will offer assessor training for new and established professionals. Discounted registration rates apply for AABB members. Individuals seeking to become AABB members can do so by checking the appropriate box on the Annual Meeting registration form or by applying online.

Leadership Opportunities Opening for Current AABB CT Section Members

Positions are available for current members of the AABB Cellular Therapy, or CT, Section who would like to seek election to the CT Section Coordinating Committee, or CTSCC. Members who serve on the CTSCC gain the opportunity to serve as leaders, meet fellow professionals in the field, provide expertise and enhance their industry knowledge. Active leadership and participation is required. The committee works collaboratively to develop educational programs, set priorities for the section and support its members. Interested CT Section members — from any CT subsection — should submit an email message by Aug. 31 to celltherapy@aabb.org stating their intention to seek election and listing subsection areas of interest. Additionally, the email should include a photo and brief summary — no more than 250 words — that describes the member's relevant experience and potential contribution to the CTSCC. To ensure fairness, submissions exceeding the word limit will not be accepted. AABB will acknowledge submissions with an email. Names, summaries and photos of qualified candidates will be posted on the AABB Center for Cellular Therapies Web page. Following the Aug. 31 submission deadline, CT Section members will receive voting instructions and ballot details. Election results will be announced during the CT Section Business Meeting and Luncheon at the Annual Meeting in Anaheim this October. Individuals seeking election are not required to attend the business meeting. AABB strongly encourages international participation.

Join in the Conversation on the AABB HUB

AABB invites members to experience the best features and functionality of popular social media platforms by joining or initiating a conversation on AABB’s new online collaborative space, the AABB HUB. The HUB offers members access to discussion groups that focus on a variety of topics including cellular therapies. Members can subscribe to discussion groups to receive email alerts when new threads are posted and reply to posts directly from their email inboxes. The AABB HUB enables participants to ask and answer questions, share ideas and network with colleagues from across the United States and around the world. Start connecting with your cell therapy peers today.

AABB CCT Is Casting A Web

The Center for Cellular Therapies wants to hear your ideas for potential webcast and webinar topics. Please submit your suggestions for educational topics that you would like to see developed or included in a webinar for the 2016 schedule to celltherapy@aabb.org.

REGULATORY AND GOVERNMENT UPDATE

AABB Urges CMS to Cover HSCT for Sickle Cell Disease Treatment

AABB submitted comments to the Centers for Medicare and Medicaid Services, or CMS, asking the agency to add sickle cell disease, or SCD, treatment to the national coverage determination for hematopoietic stem cell transplantation, or HSCT. The current lack of clarity over whether or not the treatment is covered by Medicare produces an access barrier for patients with sickle cell disease and for transplant programs, creating a risk that coverage might be denied after treatment has been completed. AABB based its comments on the severity of the disease, the clinical evidence for the efficacy of allogeneic HSCT as a treatment for SCD and the current lack of clarity over whether or not the treatment is covered by Medicare. A decision is expected in late October.

Comments to FDA, Pertinent to Cellular Therapies, on Proposed Rule “Electronic Distribution of Prescribing Information for Human Prescription Drugs, Including Biological Products”

In comments to the Food and Drug Administration, AABB recommended a dual system for 351 products that includes both electronic data and paper prescribing information to be shipped with each product. CT products have unique handling constraints that make it necessary to include printed information in addition to electronic data. Unlike traditional pharmaceuticals, CT products are unique to each patient based on HLA-matching requirements. They also are routinely cryopreserved and shipped overseas and have product-specific labeling and administration prerequisites.

House Energy and Commerce Committee Hears Testimony on Stem Cell Reauthorization Act

The United States House of Representatives’ Energy and Commerce Committee heard testimony on June 25, 2015 regarding the Stem Cell Therapeutic and Research Authorization Act of 2015. Speakers included Jeff Chell, MD, CEO of the National Marrow Donor Program (NMDP), and Joanne Kurtzberg, MD, president of the Cord Blood Association (CBA). The NMDP, which was awarded contracts under the Stem Cell Act for three components of the C.W. Bill Young Cell Transplantation Program in September 2006, operates the Office of Patient Advocacy/Single Point of Access, the Bone Marrow Coordinating Center and the Cord Blood Coordinating Center.

The Stem Cell Act — which was passed by Congress in 2005 and reauthorized in 2010 — is being considered for reauthorization again this year. It provides federal support for cord blood donation, a national bone marrow registry and research essential to increasing patient access to transplants. AABB fully supports reauthorization of the legislation and the continuation of NMDP’s important work on behalf of those in need of hematopoietic cell transplants.

RESEARCH FOCUS

Use of Laboratory Tests to Guide Initiation of Autologous Hematopoietic Progenitor Cell Collection by Apheresis: Results From the Multicenter Hematopoieic Progenitor Cell Collection by Apheresis Laboratory Trigger Survey

Makar et al used a web-based survey to determine which parameters are used to initiate autologous hematopoietic progenitor cell collection by apheresis, or HPC[A], collection in adults and pediatric patients and to identify common practice patterns. The survey, developed with members of the AABB Center for Cellular Therapies Cellular Therapy Product Collection and Clinical Practices subsection and the American Society for Apheresis HPC Donor Committee, addressed issues related to use of laboratory parameters to trigger apheresis collections reporting. According to the survey results, peripheral blood CD34+cell count was the most common parameter to initiate HPC[A] collection for both adult and pediatric patients. More than 90% of centers used a laboratory test to trigger apheresis in cytokine-mobilized or chemomobilized patients. However, only 57% used a laboratory trigger if the patient was mobilized with GM-CSF plus plerixafor. Data reveal ongoing diversity in clinical practices and suggest that consensus guidelines on use of laboratory practices may further optimize HPC[A] collection.

Broxmeyer Team Demonstrates Method to Increase Recovery of Transplantable HSCs

Hematopoietic stem cells, or HSCs, reside in hypoxic niches within bone marrow and cord blood. Yet, essentially all HSC studies have been performed with cells isolated and processed in non-physiologic, ambient air. By collecting and manipulating bone marrow and cord blood in native hypoxic conditions, Mantel et al demonstrate that brief exposure to ambient oxygen decreases recovery of long-term repopulating HSCs and increases progenitor cells, a phenomenon the research team termed extraphysiologic oxygen shock/stress, or EPHOSS. True numbers of HSCs in the bone marrow and cord blood are routinely underestimated. Reported in Cell, the team linked reactive oxgen species production and induction of the mitochondrial permeability transition pore, or MPTP, via cyclophilin D and p53 as mechanisms of EPHOSS. The MPTP inhibitor cyclosporin A protects mouse bone marrow and human cord blood HSCs from EPHOSS during collection in air, resulting in increased recovery of transplantable HSCs. Mitigating EPHOSS during cell collection and processing by pharmacological means may be clinically advantageous for transplantation.

Natural Killer Cells: In Health and Disease

Natural killer, or NK cells, constitute the bodies’ frontline defense system, guarding against tumors and launching attacks against infections. Mandal and Viswanathan present an overview of the role of NK cells −discussing the possible utilization of NK cells as immunotherapeutic agents in combating diseases such as asthma, autoimmune diseases, and HIV-AIDS. Their review, published in Hematology/Oncology and Stem Cell Therapy, also outlines current challenges in NK cell therapy.

EVENTS, OPPORTUNITIES, RESOURCES

CT AABB Audioconferences and Webinars

Upcoming 2015 CT Audioconference Programs:

09/02 Optimizing Mobilization Strategies (#154865) (AABB/ASBMT joint program)
11/18 Using Competency Assessments to Assure Quality (#154867)

Upcoming 2015 CT Webinar Schedule:

07/23 Funding Strategies for Cord Blood Banks (#1515)
08/06 Technical Topic Medley-How Cellular Therapy Facilities Handle Daily Occurrences and Quality Issues with the Available Resources (#1516)
08/20 Workload Justification and Staffing (#1517)
09/24 Topical Application and Bio-printing of Cells for Regenerative Medicine Applications (#1518)
10/01 Platelet Rich Plasma in Regenerative Medicine (#1519)
10/15 Supplier Quality Agreements for Cellular Therapy Products (#1521)

A complete listing of past 2014-2015 educational events available for purchase can be viewed on the CT Webinar page.

PEP Mentoring Programs for Early Career Professionals

Young professsionals looking to get involved in AABB CT activities or share their experiences and guidance with others may want to consider the AABB Professional Engagement Program. This informal, six-month mentoring program matches experienced professionals with those new to the field. Expand your professional network and exchange information and ideas while building lasting relationships. To request information, contact PEP@aabb.org.

Digital Version of 2nd Edition of HSCT Handbook Available in Marketplace

A digital version of the 2nd edition of Hematopoietic Stem Cell Transplantation: A Handbook for Clinicians is now available for purchase from the AABB Marketplace. The new edition adds chapters on hematopoietic stem cell transplantation, or HSCT, for nonmalignant diseases, haploidentical transplants, photopheresis, financial considerations and iron overload. The content from the 1st edition — including general principles of HSCT, pretransplant concerns, donor selection, graft preparation and more — has been updated and reorganized so readers can more easily locate topics of interest. A bundle including the digital and printed editions also is available.

FOR MEMBERS ONLY

The Latest Updates on CT Subsection Activities

Members of the AABB Center for Cellular Therapies’ subsections meet regularly via teleconferences and participate in interactive activities including the development of tools and reference materials. The materials or “projects” produced by the subsections are located on the AABB Center for Cellular Therapies Web page. Each quarter in this newsletter, we update members on some of these activities. Click on the links provided to learn more.

Asia Pacific Group, or APG: This subsection, set up to specifically accommodate members in the Asia Pacific time zones, has been expanding its discussions to bring awareness to a variety of topics including unique challenges encountered by those working in the region. APG meets via telephone on the second Wednesday of each month at 0400 UTC (universal coordinated time). Interested individuals are encouraged to enroll. Recent presentations addressed: dextran (David Stroncek, MD, National Institutes of Health), Cord Blood Regulation and Operation in Thailand (Rachanee O-Charoen, MD, Cryoviva) and “Novel Strategies of Graft Manipulation for Haploidentical Stem Cell Transplantation” (Sergio Rultella, MD, PhD, Clinical Research Center, Doha, Qatar).

Regulatory Affairs: This subsection prepared comments to several FDA documents this quarter and hosted multiple presentations including a demonstration of the AABB Standards Portal.

CT Management: This subsection discussed dealing with a variety of employee types in a range of scenarios derived from the book by Ken Lloyd “Jerks at Work.” Scenarios included “transferring troubles” focused on shifting difficult employees to different departments; “hooked on compliments,” which addressed employees requiring a lot of attention; “fear of the unknown” covering employee stress in a tight labor market; “the bottom line” focused on optimizing effects of training; and “rework those rewards,” which examined programs for giving good customer service.

Novel Therapies and CT Product Development: Subsection leaders, Pampee Young, MD, PhD (Vanderbilt University) and Magali Fontaine, MD, PhD, (University of Maryland), led a journal club. Scott Guelcher, PhD (Vanderbilt University) also gave a presentation, “A Transient Cell-Shielding Method for Viable MSC Delivery with Hydrophobic Scaffolds Polymerized in situ” as well as John McLenithan, PhD (University of Maryland Baltimore) “Characterization of Stromal-Vascular Cells Following Enzymatic Digestion or Mechanical Processing of Aspirated Adipose Tissue.”

In addition, a mesenchymal stromal cell, or MSC, work group led by Richard Schaefer, MD, (German Red Cross, Frankfurt-Mainz) met to discuss future projects and goals of the group. MSC work group members are enrolled members within the Novel Therapies and CT Product Development subsection.

CT Quality Operations: Subsection leaders Kathy Fortune, BS, MT(ASCP) (SSM Health) presented “A Bag of Tricks for Quality Managers” describing a variety of resources found by being creative in web searches and Diane Kadidlo BS, MT(ASCP) (University of Minnesota) discussed “Change Control” practices.

CT Product Collection and Clinical Practices: Associate leader, Jay Raval, MD (University of North Carolina at Chapel Hill) discussed a subsection initiative to establish standardization of infusion reaction reporting.

Cord Blood Subsection: In lieu of its June teleconference, several subsection members who attended the International Cord Blood Symposium in San Francisco met face to face to network and discuss issues related to cord blood banking, research, clinical trials and applications of cord blood in regenerative medicine. During the subsection’s July teleconference, Nick Greco, PhD, (Upstate Cord Blood Bank, New York) presented an update of the literature on “Delayed Umbilical Cord Blood Clamping” −a review originally prepared by David Harris, PhD (University of Arizona).

 

Editor: Christina Celluzzi;
Contributors: Kathy Loper and Jacqlyn Riposo

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