Transplantation of Hematopoietic Stem Cells: Role of National Transplantation Center

Transplantation of Hematopoietic Stem Cells: Role of National Transplantation Center

Transplantation of Hematopoietic Stem Cells: Role of National Transplantation Center L. Lombardini and A. Nanni Costa ransplantation of hematopoietic ...

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Transplantation of Hematopoietic Stem Cells: Role of National Transplantation Center L. Lombardini and A. Nanni Costa ransplantation of hematopoietic stem cells (HSCs) has been, for many years, a therapy choice for the treatment of many hematologic and nonhematologic diseases: leukemias, lymphomas, myeloma, congenital diseases of metabolism, immunodeficiencies, autoimmune disease, and solid tumor. The biologic basis of transplantation was first known in the 1950s with the identification of hematopoietic stem cells in bone marrow and elucidation of the major histocompatibility system. The first pioneering transplantation attempts were performed in the 1950s and 1960’s, and the first successful procedure was described by Gatti et al in November 1968.1 In 1975, the Seattle group published the results of the first 110 implanted patients, providing the basis for the clinical application of bone marrow transplantation on a large scale.2 Until the early 1990s, the only source of stem cells was bone marrow (BM); thereafter, HSCs were also derived from peripheral blood and then cord blood. In Italy, transplantation activity in the past years has stabilized at 4,000 procedures per year. The increase in numbers of transplantation procedures using HSCs is far greater than the refinement of transplantation techniques: supportive therapy, new techniques for HLA typing, and approaches to treat complications. This observation is also linked to the increasing number of transplantation centers to ⬎100 throughout Italy. A transplantation center is accredited by a regional authority. The Transplantation Program, consisting of clinical care, processing, and collection of units, must meet certain technical, organizational, and quality requirements to ensure safety for the donor and the patient. Given the complexity of transplantation, it is clear that this must be defined within a treatment program that provides for the coordinated actions of multiple structures and/or professionals. From an organizational view, the Italian transplantation network consists of a series of national and international clinical and scientific societies that are involved in bone marrow transplantation. In particular, transplantation centers refer to the Italian Group for Bone Marrow Transplantation (GITMO), its purpose being the development and progress of HSC transplantation technology through educational aspects as well as standardization of procedures and medical and nursing quality control activities. The search for unrelated donors is managed by a national registry, the Italian Bone Marrow Donor Registry

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(IBMDR) which, as of 1989, is located at the Galliera Hospital in Genoa. In 2001, the IBMDR received institutional recognition (law no. 52, March 6), and since February 2007 it manages the search for adult donors and blood cord units (State-Regions Agreement of October 5, 2006 on the research and retrieval of HSCs by Italian and international registries and banks). There are national and European regulations, which are designed to regulate the activities of the centers. The rules of reference are the following: State-Regions Conference of July 10, 2003, “Guidelines concerning the collection, manipulation, and clinical use of hematopoietic stem cells.”3 European Directive 2004/23/EC of March 31, 2004, on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells4 (and Guidelines EU 2006/17/EC5 and 2006/86/EC,6 which specify the technical requirements of 23/2004). State-Regions Conference of September 23, 2004, “Guidelines on how to regulate the activities of retrieval, treatment, storage, and distribution of cells and tissues for the purpose of transplantation, in implementation of article 15, paragraph 1 of Law 91/1999.7 Law no. 219, October 21, 2005, “New discipline of transfusion activities and national blood production.”8 State-Regions Agreement of October 5, 2006 on research and retrieval of hematopoietic stem cells at registries and Italian and foreign banks.9 Legislative Decree no. 191, November 6, 2007, “Implementation of Directive 2004/23/EC definition of standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of tissues and cells.”10 Within this complex organization and in accordance with applicable regulations, the National Transplantation Center (CNT), established by Law no. 91, April 1, 1999, plays an important role in the network management of data collecFrom the National Transplantation Center, Rome, Italy. Address reprint requests to Dr. Letizia Lombardini, National Transplantation Center, Via Giano della Bella 34, 00162 Roma, Italy. E-mail: [email protected]

© 2010 Published by Elsevier Inc. 360 Park Avenue South, New York, NY 10010-1710

0041-1345/–see front matter doi:10.1016/j.transproceed.2010.05.025

Transplantation Proceedings, 42, 2241–2243 (2010)

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tion on transplantation activity. It has the task of setting parameters for the quality of transplantation structures. The role of the CNT in HSC transplantation is better defined in Legislative Decree no. 191, November 6, 2007, which established (chapter III) specific areas of competence through the for the Ministry of Health, Regions, and Autonomous Provinces with the support of the CNT and the National Center for Blood (CNS). Its provisions include: supervision of human tissue and cell procurement (article 5); inspections and control measures (article 7); traceability (article 8); importation and exportation of tissues and cells (article 9); registry of tissue establishments and reporting obligations (article 10); and notification of serious adverse events and reactions (article 11). Supervision of Human Tissue and Cell Procurement (Article 5)

According to this article, the selection and collection of tissue/cells must be performed by personnel with appropriate training and experience (articles 17 and 18), based on specific requirements for each type of tissue/cell (article 28, b and d)), the results of laboratory tests (article 28, e) through procedures and operational protocols for procurement of cells/tissues, and their receipt by the tissue establishment (bank/process units). In addition to the criteria selection under the European Directive 17/2006, there are also specific selection criteria for stem cells, which refer to local regulations and guidelines/national and international standards (Foundation for the Accreditation of Cellular Therapy, Joint Accreditation Committee [JACIE]). Inspections and Control Measures (Article 7)

Based on its experience in the inspection of tissue banks, the CNT, in collaboration with the CNS, has developed a program of inspections at the centers that collect, process, store, and distribute HSCs to verify compliance with the requirements of current legislation and European Union directives. Where possible, inspections are conducted in collaboration with JACIE. The program began in 2006 with the request for a self-assessment questionnaire. As of 2007, inspections have begun at individual centers. Regarding cord blood banks, the CNS in conjunction with the CNT began a program to audit cord blood banks, conducted on the basis of 2008 European directives. Traceability (Article 8) and Registry of Tissue Establishments and Reporting Obligations (Article 10)

Legislative Decree no. 191 states to: “set the necessary measures to ensure for all tissues and cells procured, processed, stored, or distributed in the national territory tracing of the path from donor to recipient and vice versa. This traceability also covers information relating to products and materials that come into contact with these tissues and cells”; and that “a system for identifying donors, which assigns a unique code to each donation and each of the products derived from it,” be established. Data for HSCs for unrelated donors (donor adult cord blood) are managed

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by the national donor registry, the IBMDR that registers adult donors and cord blood units; each donor is identified with a unique code. The donors included in the national registry are also visible internationally through the Bone Marrow Donor Worldwide registry. The IBMDR has established specific standards for the management of donors and research protocols as well as selection and suitability of the donor, clearly taking into account the provisions of the law regarding quality and safety of the donor and the recipient. These standards were accepted by the CNT in the consultation of May 27, 2008. Data collection regarding transplantation and follow-up of patients is managed by GITMO via the registration by the transplantation centers of their case studies into the Promise software (European Group for Blood and Marrow Transplantation). There is an agreement between GITMO and CNT, which states that each is responsible for the reporting of transplants for 4 months at a time. Import and Export of Tissues and Cells (Article 9)

Under article 16, paragraph 4, of Law no. 219/2005, the import and export of HSCs for transplantation is regulated by law. The IBMDR manages the entire procedure for these activities. The authorization to import and export HSCs is issued by the Ministry of Health (Office VIII, Department of Prevention and Communication, General Management Prevention Clinic). Notification of Serious Adverse Events and Reactions (Article 11)

After June 1, 2007, the National Transplantation Center introduced a system of communication and management of events and serious adverse reactions related to tissues, for any immediate and coordinated action that is necessary in case of any unexpected event that could occur within the transplantation network. The system covers all tissue establishments, the regional transplantation centers, and the CNT. Regarding HSCs, the network is under development to include involvement of transplantation centers, tissue institutes (banks), the IBMDR (in case of unrelated donor), GITMO, the CNS, and the CNT. REFERENCES 1. Gatti RA, Meuwissen HJ, Allen HD, et al: Immunological reconstitution of sex-linked lymphopenic immunological deficiency. Lancet 2:1366, 1968 2. Thomas ED, Storb R, Clift RA, et al: Bone Marrow Transplantation. N Engl J Med 292:895, 1975 3. State-Regions Conference of July 10, 2003: “Guidelines concerning the collection, manipulation, and clinical use of hematopoietic stem cells (HSCs)”. September 30, 2003 4. European Directive 2004/23/EC of March 31, 2004, on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of tissues and cells 5. European Directive 2006/17/EC of August 2, 2006, implementing Directive of the European Parliament and Council regarding certain technical requirements for the donation, procurement, and control of tissues and cells

CENTER FOR TRANSPLANTATION OF HEMATOPOIETIC STEM CELLS 6. European Directive 2006/86/EC of October 24, 2006, implementing Directive of the European Parliament and Council regarding the technical requirements for traceability, notification of serious adverse reactions and events, and certain technical requirements for the coding, processing, preservation, storage, and distribution of tissues and cells 7. State-Regions Conference of September 23, 2004: Guidelines on how to regulate the activities of retrieval, treatment, storage, and distribution of cells and tissues for the purpose of transplantation, in implementation of article 15, paragraph 1 of law no. 91/1999, OJ 248, October 21, 2004

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8. Law no. 219, October 21, 2005: “New discipline of transfusion activities and production National blood products.” no. 251, October 27, 2005 9. State-Regions Agreement of October 5, 2006, on research and retrieval of hematopoietic stem cells at registries and Italian and foreign banks 10. Legislative Decree no. 191, November 6, 2007: “Implementation of Directive 2004/23/EC definition of standards of quality and safety for the donation, procurement, testing, processing, preservation, storage, and distribution of human tissues and cells