AABB CellSource - October 2015

 
AN UPDATE ON CELL THERAPY NEWS FROM AABB
October 2015

IN THE NEWS

Workshop Highlights Current Thinking on Mesenchymal Stromal Cells

Places are still available for AABB’s pre-conference workshop, “Mesenchymal Stromal Cells: Are They Ready for Prime Time?” on Friday, Oct. 23 at the Anaheim Convention Center. Experts will discuss current thinking on how best to characterize mesenchymal stromal cells, or MSCs, their functionality and considerations for manufacturing them for research and commercial use. Researchers will relate the latest clinical findings on the use of MSCs to treat ischemia, lung disease and neurodegenerative disorders. The workshop also will feature sessions on regulatory considerations and end with a networking reception, which is open to all Annual Meeting attendees interested in cellular therapy.

CT Section Invites its Members to Lunch and Learn at its Annual Business Meeting

CT Section members have the opportunity to share the past year’s events and consider future activities while enjoying lunch together. Attendees can network with other CT professionals, learn about the activities of the topic-driven subsections and meet this year’s Cell Therapies Section Coordinating Committee, or CTSCC, including the newly elected members. The CT Section Business meeting will be held on Monday, Oct. 26 from noon-2:00 pm in the Anaheim Convention Center.

Networking Session Offered With a NEW Twist

Solve It! Scenarios in Cellular Therapy is a new format to bring out individuals’ inner Sherlock in solving issues in CT. Recognizable case scenarios will be presented to attendees in small groups to promote interactive discussions and generate potential resolutions. This program will allow attendees to select topics of particular interest and rotate through multiple scenario case presentations — with the intent of creating a congenial, informal and informative atmosphere. No preparation is needed. Attendees are invited to brainstorm in lively interactions and network with their fellow CT sleuths. The ‘Solve It!’ session will be held Saturday, Oct 24, 2:00-3:30 pm in the Anaheim Convention Center.

Tools Available to Help Navigate the Annual Meeting

Various media are available to help attendees navigate the myriad of activities available this year at Annual Meeting. The AABB app has many useful features to help participants stay organized and personalize schedules with current exhibitor, speaker and event information. Users can sync the app across devices and communicate with fellow attendees via Twitter. The app is compatible with Apple, Android and other Windows-based devices and will be active before, during and after the meeting. Use it to stay in the know.

For those who prefer to be unplugged, a hard copy of “CT Schedule At A Glance” will be available at Annual Meeting kiosks and posted on the AABB website.

Invitation to Look Ahead and Contribute to the AABB 2016 Annual Meeting

It may seem early to begin thinking about 2016 sessions, but take a little time to ponder which CT programs you would benefit from in the new year. The Annual Meeting Education Program Unit, a group of dedicated AABB members involved in the selection and organization of education programs, is soliciting proposals for educational programs to be presented at the 2016 Annual Meeting in Orlando, Fla. The Annual Meeting Program proposal site is open for submissions. The submission deadline is Nov. 13. Please send any questions to the Education and Professional Development Department at professionaldevelopment@aabb.org.

REGULATORY AND GOVERNMENT UPDATE

FDA Releases Final Guidance on HCT/P Donor Screening for T. pallidum

The FDA announced the availability of a guidance document, “Use of Donor Screening Tests to Test Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis).” The document provides FDA’s updated recommendations for establishments that determine the eligibility for donors of HCT/Ps. FDA clarifies in the guidance that it does not consider cleared or approved diagnostic tests or pre-amendment devices to be adequate for use in donor testing for T. pallidum infection under criteria specified in 21 CFR 1271.85. AABB provided input to FDA on the draft guidance through comments it submitted in Jan. 2014.

Proposed Rulemaking: Federal Policy for the Protection of Human Subjects

The U.S. Department of Health and Human Services and fifteen other federal departments and agencies have proposed revisions to modernize, strengthen and make more effective the Federal Policy for the Protection of Human Subjects. A Notice of Proposed Rulemaking was made available on Sept. 2. The public is invited to comment on proposals to better protect human subjects involved in research. Comments are due by Dec. 7, 2015.

GAO Report on “Regenerative Medicine: Federal Investment, Information Sharing, and Challenges in an Evolving Field”

The Government Accountability Office, or GAO, published a report on federal involvement in the field of regenerative medicine. The report describes which federal agencies conducted or funded regenerative research in recent years and how these agencies invested their resources, the activities these agencies undertook to share information across agencies, challenges to advancing the field of regenerative medicine identified by federal agencies and other stakeholders and the steps taken, if any, to address them.

RESEARCH FOCUS

Video on the History of Transplantation — Celebrating a Second Chance at Life

A video produced by BMT Infonet.org delivers a fascinating look at the history of bone marrow, stem cell and cord blood transplantation featuring survivors from the early days of transplant. Matthew Farrow, recipient of the world’s first cord blood transplant who appeared as a child in the video, is currently a patient advocate and works in the corporate office of a hybrid public/private cord blood bank. An interview with Farrow appears in the Parent's Guide to Cord Blood Foundation newsletter.

Global Stem Cell Array Brings Precision Medicine Closer to the Clinic

New York Stem Cell Foundation, or NYSCF, researchers designed and built a high-throughput robotic platform, NYSCF Global Stem Cell ArrayTM, which automates and standardizes the process of transforming patient samples into stem cells. Paull et al describe in “Nature Methods” the application of the modular platform for induced pluripotent stem cells, or iPSCs. iPSCs are an essential tool for modeling how causal genetic variants impact cellular function in disease. They are also an emerging source of tissue for regenerative medicine. The automated reprogramming platform enables conversion of cells from skin biopsies into iPSCs and differentiated cells with minimal manual intervention, demonstrating that automation and the pooled selection of polyclonal pluripotent cells results in high-quality, stable iPSCs. It is reported that this approach would enable the application of iPSCs to population-scale biomedical problems, including the study of complex genetic diseases and the development of personalized medicines.

Process Development Considerations for Cell Therapy

The development of robust and well-characterized methods of production of cell therapies has become increasingly important as therapies advance through clinical trials and approval. Successful cell therapies need to be consistent, safe and effective. Process development strategies can be developed to gain efficiency while maintaining or improving safety and quality profiles. In their review in “Stem Cells Translational Medicine,” Campbell et al present an introduction to the process development challenges of cell therapies and describe some of the tools available to address production issues.

Patient-Funded Trials: Opportunity or Liability?

Patient-funded trials, or PFTs, are gaining traction as a means of accelerating clinical translation. However, according to Wenner et al in “Cell Stem Cell,” such trials sidestep mechanisms that promote rigor, relevance, efficiency and fairness. The authors recommend that funding bodies or research institutions establish mechanisms for merit review of patient-funded trials and offer some basic criteria for evaluating PFT protocols.

EVENTS, OPPORTUNITIES, RESOURCES

Abstracts for the 2015 AABB Annual Meeting Published in TRANSFUSION

Abstracts to be presented at the AABB Annual Meeting are available online and in hardcopy. Materials are divided into scientific and administrative sections. AABB acknowledges everyone who contributed to the meeting journal supplement, including submitters, presenters, graders, directors, editors and members of the Selection of Abstracts Program Unit and Annual Meeting Education Program Unit.

CT AABB Audioconferences and Webinars

Upcoming 2015 CT Audioconference and Webinar Programs:

11/18 Using Competency Assessments to Assure Quality (#154867) (audioconference)
11/19 Funding Strategies for Cord Blood Banks (#1515) (webinar — please note new date)

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

Volunteer Opportunities for Early Career Members

AABB has created junior member positions on association year 2015-16 committees that will allow early career individuals to gain experience, contribute to important deliverables, network and learn more about operations and how the association develops policies and positions. Members who would like to apply or who know of others who might be interested in this opportunity for the 2016-17 association year are encouraged to visit the AABB Website Committee Volunteer Opportunities page.

FOR MEMBERS ONLY

The Latest 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, which specifically accommodates members in the Asia Pacific time zones, has been expanding its discussions to bring awareness to a variety of topics, including challenges unique to 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. Matt Delgado, CQA(ASQ), of ICCBBA, recently addressed the “Global Status of ISBT 128 Implementation for Cellular Therapy.” Further presentations on topics including “HLA for Transplantation” and “The Role of Private Cord Blood Banks in Regenerative Medicine” are planned in the coming months.

Regulatory Affairs: This subsection was treated to multiple presentations including a history of the AABB Standards, “Stem Cell Collection Standards and their Clinical Background,” by Joseph (Yossi) Schwartz, MD. “Three Years in Summary,” describing events occurring during her tenure as the leader of the subsection, was presented by Fran Rabe, MS, CQM(ASQ).

CT Management: This subsection continued an interesting discussion dealing with a variety of employee types in a range of scenarios derived from the book by Ken Lloyd, “Jerks at Work.” If you are interested in joining a discussion on scenarios involving worker interactions and CT-work situations, plan to attend the Solve It! Scenarios in Cellular Therapy on Saturday, Oct 24 from 2:00-3:30 pm. Scenarios involving topics from all of the other subsections will also be presented.

Novel Therapies and CT Product Development: Abba Zubair, MD, PhD, presented “Feasibility Studies to Assess the Application of Stem Cells to Treat Pressure Ulcers.” Subsection leaders Pampee Young, MD, PhD, and Magali Fontaine, MD, PhD, led a journal club on mesenchymal stromal cells, or MSCs.

Richard Schaefer, MD, who started a workgroup focused on MSCs, began a discussion thread on the AABB HUB based on two articles covering MSC heterogeneity and the mechanism of MSC-mediated immunosuppression in mammalian species. CT members are welcome and encouraged to join the AABB HUB to contribute their thoughts to this thread, as well as to contribute to the other discussions in the Cellular Therapies Forum. Schaefer will be one of the speakers in the MSC Workshop to be held prior to the start of the AABB Annual Meeting.

CT Quality Operations: Subsection leaders Kathy Fortune, BS, MT(ASCP), and Diane Kadidlo, BS, MT(ASCP), discussed a variety of challenges and topics including deviation reporting.

CT Product Collection and Clinical Practices: Subsection leaders Michele Sugrue, MS, MT(ASCP)SBB, Tom Spitzer, MD, and Jay Raval, MD, discussed their ongoing projects, which include a narrative review on collection triggers for HPC, Apheresis; an initiative to establish standardization of infusion reaction reporting; and a recent survey on bone marrow collection quality improvement. The survey, which was created by the Bone Marrow Collection Quality Improvement Initiative interorganizational workgroup, includes questions on autologous red cell collection and transfusion practices for allogeneic bone marrow donor harvests. The workgroup comprises representatives from AABB, ASBMT, CIBMTR, DOD and NMDP.

Cord Blood Subsection: Several presentations were delivered. Ivan N. Rich, PhD, discussed “Detecting Primitive HSCs in Total Nucleated and Mononuclear Cell Fractions from UCB Segments and Units” and Omar Aljitawi, MD, presented his novel research, “Modulating the Recipient Microenvironment Using Hyperbaric Oxygen Therapy to Improve Umbilical Cord Engraftment.”

Face to Face Subsection Meetings to be held at AABB Annual Meeting

CT subsection members will have the opportunity to meet face to face in Anaheim. Morning meetings will be held from 7:00-8:00 am in the Hilton, room Huntington A/B/C, according to the following schedule: Cord Blood, CT Product Manufacturing and Testing, and APG subsections will meet on Saturday, Oct. 24. Regulatory Affairs, Quality Operations, and CT Management subsections will meet on Sunday, Oct. 25. CT Product Collection and Clinical Practices and Novel Therapies and CT Product Development will meet on Monday, Oct.26.

 

Editor: Christina Celluzzi
Contributors: Kathy Loper and Jacqlyn Riposo


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