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FDA Licenses First Cord Blood Product
Making history, the Food and Drug Administration has licensed the first umbilical cord blood product for use in hematopoietic stem cell transplants. According to the FDA, New York Blood Center's Hemacord (hematopoietic progenitor cells, cord blood) is indicated for "unrelated donor hematopoietic progenitor cell transplantation procedures in conjunction with an appropriate preparative regimen for hematopoietic and immunologic reconstitution in patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment."
AABB Partners With International Cellular Medicine Society To Provide Global Accreditation
AABB and the International Cellular Medicine Society, or ICMS, announced at the 2011 AABB Annual Meeting in San Diego that they have formed an alliance under which the two organizations will explore working together to develop global accreditation for clinics and facilities providing autologous cell-based medical treatments. The initiative aims to boost the transparency of facility operations and their offered treatments so patients can make better-informed health care decisions. AABB assessors will perform assessments against the requirements of ICMS. Both organizations will identify individuals to form a work group to translate the standards developed by ICMS into requirements for the accreditation program. Several facilities have been identified as pilot sites for the accreditation process, with implementation planned for spring 2012.
NCI Releases Best Practices for Biospecimen Resources
The National Cancer Institute has released the revised NCI Best Practices for Biospecimen Resources. According to the institute, the document "identifies guiding principles defining state-of-the-science practices for biospecimen resources, promoting biospecimen and data quality, and supporting adherence to ethical and legal principles." The new version includes more current and detailed recommendations and responds to comments received from community stakeholders. Revisions include an interactive online format that allows greater flexibility and access to the information and new sections on conflicts of interest and the management and operation of biospecimen resources.
Opportunities for Participation and Funding
Subsection Issues Invitation to Administrative Professionals
Kevin L. Bundy, BB, MLScm(ASCP)SBB, operations manager for Transfusion Medicine at the Mayo Clinic in Rochester, Minnesota, serves as the new leader of the CT Business Management subsection and welcomes all interested members to the group. "I believe we have much to learn from each other in how we manage and operate our cell therapy facilities," said Bundy. Topics to be addressed in the subsection include workload recording, cost accounting, job descriptions, staffing models, personnel management/project management and strategic planning. Click here to join and learn more.
Contribute to the 2012 Annual Meeting Program
AABB's Annual Meeting Education Program Unit is accepting proposals for educational programs for the 2012 AABB Annual Meeting and CTTXPO until Nov. 28. Proposal submissions for 90-minute and three-hour programs focused on quality, technical, scientific and administrative topics in cellular therapies are encouraged. The Program Proposal form is available on the AABB website. Completed forms may be faxed to +1.301.951.3729 or emailed by November 28, 2011.
AABB Community Offers Technical Assistance and Advice
Nearly 200 AABB members have joined the CT group within the AABB Community! Similar to other social media tools, the AABB Community provides individual members the opportunity to discuss important topics, post questions or comments, learn from one another and share technical and practical findings for continuous self-improvement. In addition, the platform provides an avenue to help individual members network with colleagues. Lizette Caballero, BsMT(ASCP), Blood and Marrow Transplant Laboratory, University of California, San Francisco, has recently been named the CT group's new moderator. Want to put a face with a name? Join your colleagues and subscribe to discussion email alerts now.
2012 NBF Grant Applications Due Dec. 30
Individuals interested in applying for the National Blood Foundation's 2012 scientific research grants are reminded that the deadline for submission is Dec. 30, 2011. NBF annually awards transfusion medicine and cellular therapy grants for one- or two-year research projects, with a maximum award of $75,000 per grant. Priority will be given to new investigators and innovative projects with the potential to improve patient safety and donor health. Instructions and application guidelines are available to assist applicants with the process. Grant winners will be notified in June and funds will be disbursed in July 2012. The November issue of Transfusion includes a supplement from the National Blood Foundation spotlighting NBF-funded research conducted by early-career transfusion medicine investigators in the cellular therapy field. In the last decade, the field of cellular therapy has become a focus of NBF's grants program.
Member Benefits
Regenerative Medicine Journal Offered to AABB Members
 New this year! AABB is offering members the Regenerative Medicine Journal at a discounted rate. The award-winning Medline referenced journal, available for $30 as a six-issue online subscription, provides a forum for addressing important challenges and advances in regenerative medicine and stem cell research. Coverage includes bench-to-bedside translation and scale up of stem cell and regenerative medicine therapies. Potential applications for stem cell-based strategies in pathological conditions and emerging technologies also are included. The subscription option is available with online membership renewal and in the AABB Marketplace.
Slides Available From Radiation Injury Treatment Workshop
The Radiation Injury Treatment Network (RITN) has posted the slides from its workshop "Radiation Exposure, Medical Countermeasures and Treatment," held Oct. 11 in Chicago. Among the presentations were those on stem cell-based therapies for acute radiation syndrome, mitigation of hematopoietic syndrome and strategies to enhance immune reconstitution after irradiation. The network is a cooperative effort of the National Marrow Donor Program (NMDP) and the American Society for Blood and Marrow Transplantation (ASBMT). The AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism is an RITN partner.
New References
Cord Blood: Biology, Immunology, Banking, and Clinical Transplantation
 The relatively new field of cord blood is still evolving, having seen vast change since the first successful cord blood transplantation more than 20 years ago. Cord Blood: Biology, Immunology, Banking, and Clinical Transplantation, by cord blood pioneer Hal Broxmeyer, PhD, aims to continue advancing the clinical efficacy and relevance of this area by providing a solid understanding of its present status. This comprehensive resource on cord blood incorporates the latest developments into 39 chapters by experts in various areas of practice. Topics include cord blood biology, engraftment and regenerative medicine.
New Digital Download Available: Core Principles in Cellular Therapy
 The chapters of the Core Principles in Cellular Therapy digital download form a key resource for a distinct readership in laboratories that typically have not used the Technical Manual. Highlights include a revised section on quality control in the marrow chapter and new data on adhesion-blocking agents in apheresis collections. This economically priced resource is great for training medical staff.
Regulatory Update
FY2012 Deviation Reporting Code Changes for HCT/P
In October, the Food and Drug Administration released changes to the codes for deviation reporting for human cells, tissues and cellular- and tissue-based products for fiscal year 2012. New codes for the HCT/P establishments include codes for facility and equipment deviations. Changes made on Oct. 1 are identified with a dagger (†).
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Dendritic Cells: A Look Into the Past as a Look Toward the Future
The 2011 Nobel Laureates in Medicine revolutionized our understanding of the immune system by discovering key principles for its activation. Bruce A. Beutler, MD, and Jules A. Hoffmann, PhD, were awarded the prize for their discoveries concerning the activation of innate immunity, and Ralph M. Steinman, MD, won for his discovery of the dendritic cell and its role in adaptive immunity. Immunology is pivotal to major problems in medicine. These discoveries provided novel insights and made possible the development of new methods for preventing and treating disease with improved vaccines against infection and stimulation of the immune response to attack tumors. Recently, dendritic cells have been incorporated in a cellular immunotherapy approach against prostate cancer, which has been approved by the Food and Drug Administration. Readers are invited to (re)visit a Ralph Steinman article, published in 2007, that provides a glimpse into the history of dendritic cells, his own journey into their discovery, and his description of "dendritic cells as part of the tapestry of immunology and medicine."
Ocular Epithelial Transplantation: Current Uses and Future Potential
Visual loss may be caused by a variety of ocular diseases and places a significant burden on society. Replacing or regenerating epithelial structures in the eye has been demonstrated to recover visual loss in a number of such diseases. Several types of cells (e.g., embryonic stem cells, adult stem/progenitor/differentiated epithelial cells and induced pluripotent cells) have generated much interest and research into their potential for restoring vision in a variety of conditions: from ocular surface disease to age-related macular degeneration. While there has been some success in clinical transplantation of conjunctival, and particularly corneal, epithelium utilizing ocular stem cells, in particular from the limbus, the replacement of the retinal pigment epithelium by utilizing stem cell sources has yet to reach the clinic. Advances in our understanding of all of these cell types, their differentiation and the subsequent optimization of culture conditions and development of suitable substrates for their transplantation will enable us to overcome current clinical obstacles. This description and review by Mason et al. appears in the journal Regenerative Medicine and addresses the current status of knowledge concerning the biology of stem cells, their progeny and the use of differentiated epithelial cells to replace ocular epithelial cells. Clinical outcomes to date and the potential for future clinical use are highlighted.
Creating Stem Cells From Humans Moving a Step Closer
Researchers from the Erasmus University in Rotterdam in The Netherlands have discovered the protein that causes embryonic stem cells to develop into any type of cell in the body. This discovery, made in mice, is an important step for creating new cells from adult cells. From adult body cells, it is theoretically possible to create stem cells, but the problem is that these stem cells "do not forget where they came from." If for example, one needs stem cells to repair a defect in the heart muscle, it is difficult to first retrieve the cells from the heart. It might be useful to use skin cells for that purpose and transform them into stem cells to repair the damaged heart tissue. However, those stem cells retain "memory" of their skin origin, so it is not easy to change them into heart cells that can help. Ten Berge et al. in an article appearing in Nature Cell Biology describes their studies on the Wnt protein, which researchers hope will allow ways to circumvent this problem and make embryonic-like stem cells of the body's cells, which then can be used anywhere, eliminating the need for stem cells from embryos.
Resources
Cellular, Tissue and Gene Therapies Advisory Committee September 22-23 Meeting Transcripts read more
Webinar Slides on Implementation of ISBT 128 in Cellular Therapies read more
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