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Allogeneic Hematopoietic Stem Cells from Sources Other Than Bone Marrow review Haematologica 1997; 82:220-238 ALLOGENEIC HEMATOPOIETIC STEM CELLS FROM SOURCES OTHER THAN BONE MARROW: BIOLOGICAL AND TECHNICAL ASPECTS FRANCESCO BERTOLINI, ARMANDO DE VINCENTIIS, LUIGI LANATA, ROBERTO M. LEMOLI, RITA MACCARIO, IGNAZIO MAJOLINO, LUISA PONCHIO, DAMIANO RONDELLI, ANTONIO TABILIO, PAOLA ZANON, SANTE TURA Division of Oncology, IRCCS Fondazione Maugeri, Pavia; Dompé Biotec SpA, Milan; Amgen Italia SpA, Milan; Istituto di Ematologia ed Oncologia Medica “Seràgnoli”, University of Bologna, Bologna; Department of Pediatrics, IRCCS Policlinico S. Matteo di Pavia, Pavia; Department of Hematology and BMT Unit, Ospedale “V. Cervello”, Palermo; Department of Internal Medicine, University of Pavia and IRCCS Policlinico S. Matteo, Pavia; Institute of Hematology, University of Perugia, Italy ABSTRACT Background and Objective. Identification and CSF, or from cord blood upon delivery, are capa- characterization of hematopoietic stem cells in ble of supporting rapid and complete reconstitu- peripheral blood (PB) and cord blood (CB) have tion of BM function in allogeneic recipients. suggested feasible alternatives to conventional Perhaps more importantly, reinfusion of large allogeneic bone marrow (BM) transplantation. numbers of HLA-matched T-cells from PB collec- The growing interest in this use of allogeneic stem tions or T-cells with various degrees of HLA dis- cells has prompted the Working Group on CD34- parity from CB did not result in a higher incidence positive Hematopoietic Cells to review this subject or greater severity of acute graft-versus-host dis- by analyzing its biological and technical aspects. ease than expected with BM. Based on the data Evidence and Information Sources. The method reviewed, operative guidelines for mobilization, used for preparing this review was informal con- collection and graft processing are provided. sensus development. Members of the Working Perspectives. It should be remembered that Group met three times, and the participants at despite the growing interest, these procedures these meetings examined a list of problems previ- must be still considered as advanced clinical ously prepared by the chairman. They discussed research and should be included in formal clinical the individual points in order to reach an agree- trials aimed at demonstrating their definitive role ment on the various concepts, and eventually in stem cell transplantation. In this regard, a large approved the final manuscript. Some of the European randomized study is currently compar- authors of the present review have been working ing PB and BM allografts. However, the possibility in the field of hematopoietic stem cell biology and of collecting large quantities of hematopoietic processing, and have contributed original papers progenitor-stem cells, perhaps with reduced allo- published in peer-reviewed journals. In addition, reactivity, offers an exciting perspective for widen- the material examined in the present review ing the number of potential stem cell donors and includes articles and abstracts published in jour- greater leeway for graft manipulation than is pos- nals covered by the Science Citation Index® and sible with BM. ® Medline . ©1997, Ferrata Storti Foundation State of Art. Several studies have now shown that hematopoietic stem cells collected from Key words: hematopoietic stem cells, bone marrow, cord blood, peripheral blood after the administration of G- peripheral blood, allogeneic transplantation, graft-versus-host disease llogeneic bone marrow transplantation has hematopoietic stem cells itself. Whereas this had progressed from a highly experimental proce- always been by definition the bone marrow since dure to being accepted as the preferred form the very beginning, identification of stem cells in A 1 of treatment for a wide variety of diseases. There peripheral and cord blood has now provided useful have been impressive improvements in this thera- alternatives. peutic procedure in the last two decades, but the In 1994 the growing interest in the use of periph- most important advances probably took place in eral blood stem cells (PBSC) in the setting of allo- the last few years and concern the source of geneic bone marrow transplantation induced the Correspondence: Prof. Sante Tura, Istituto di Ematologia ed Oncologia Medica “Seràgnoli”, Policlinico S. Orsola, via Massarenti 9, 40138 Bologna, Italy. Acknowledgments. Preparation of this manuscript was supported by grants from Dompé Biotec SpA and Amgen Italia SpA, Milan, Italy. *This review article was prepared by a group of experts designated by Haematologica and by representatives of two pharmaceutical companies, Amgen Italia SpA and Dompé Biotec SpA, both from Milan, Italy. This co-operation between a medical journal and pharmaceutical companies is based on the common aim of achieving an optimal use of new therapeutic procedures in medical practice. In agreement with the Journal’s Conflict of Interest Policy, the reader is given the following information. The preparation of this manuscript was supported by educational grants from the two companies. Dompé Biotec SpA sells G-CSF and rHuEpo in Italy, and Amgen Italia SpA has a stake in Dompé Biotec SpA. This paper has undergone a regular peer-review process and has been evaluated by two outside referees. Received August 22, 1996; accepted January 20, 1997. Non bone marrow allogeneic hemopoietic stem cells 221 GITMO (Gruppo Italiano Trapianto di Midollo Osseo) to operative site morbidity. As many as 10 percent of promote a Study Committee for evaluating the key donations were associated with fever, and increas- aspects of allogeneic PBSC collection and trans- ing donor age was significantly linked to poor cell plantation. This Committee produced a list of rec- harvest. In a different survey, 10 percent of donors ommendations that were published as a position recovered completely from marrow donation only paper in this Journal at the beginning of 1995.2 In more than 30 days after the procedure.7 summary, the authors strongly recommended the PBSC transplantation represents an alternative use of allogeneic PBSC in experienced centers, in approach. In autologous transplantation peripheral well-defined clinical settings, and possibly – for the blood is now replacing bone marrow as a source of time being – in patients with advanced disease. progenitor cells.8 The advantage is quicker hema- As the use of PBSC expanded both in the autolo- topoietic recovery9,10 with consequently fewer com- gous and the allogeneic setting, expression of the plications and shorter hospital stay. CD34 antigen became increasingly important for In the autologous setting, PBSC can be collected their characterization. An ad hoc working group after mobilization with chemotherapy,11,12 growth reviewed the biology and clinical relevance of factors,13 or a combination of the two.14 In a ran- CD34-positive cells in this journal in 1995.3 In par- domized study, leukaphereses created less anxiety ticular, techniques for CD34-positive cell separa- and pain than bone marrow harvest.15 tion and procedures for their collection from In allogeneic transplantation, the use of PBSC peripheral blood were analyzed. A brief chapter was has been somewhat delayed by a possible increase also devoted to CD34-positive cells in cord blood.3 in graft-versus-host disease (GVHD) as a conse- The working group on CD34-positive hemato- quence of the much higher number of lymphocytes poietic cells subsequently reviewed the use of PBSC in the graft inoculum, and by the need for a mobi- in acute myeloid leukemia4 and multiple myeloma.5 lization treatment for healthy individuals in order to The growing interest in the use of PBSC and cord obtain a good cell yield. However, the clinical expe- blood stem cells in the setting of allogeneic trans- rience of the last two years suggests that the inci- plantation has now prompted the working group dence of acute GVHD is not increased with PBSC to review this subject by analyzing its biological and as compared to marrow, and that in healthy technical aspects. donors a sufficient cell number can be obtained by using growth factors alone, in particular G-CSF.16-20 As a consequence, the number of allogeneic PBSC PBSC mobilization and collection in normal transplants is increasing rapidly. The European donors Blood and Marrow Transplant Group (EBMT) reg- Until recently, the collection of hematopoietic istered only 12 PBSC allografts in 1993, but their cells for allogeneic transplantation has required number increased to 180 in 1994 and to 537 in general or spinal anesthesia and multiple punctures 1995 (Gratwohl, personal communication). of iliac bones. However, marrow harvesting is not completely devoid of complications, side effects or Collection of PBSC in normal donors patient discomfort. In a report on 1270 harvest On biological grounds, there are several means of procedures in Seattle,6 6 donors suffered life-threat- mobilizing progenitor cells into the peripheral ening complications and 10 showed significant blood, but their ultimate modality of action is always detachment of the CD34+ progenitor cell from marrow stroma and endothelium, to which it is normally bound by interactions with different integrin-adhesion molecules.3,21 We may induce Table 1. Relationship between CD34+ cell yield and G-CSF dose in allogeneic PBSC donors. Only clinical experiences are detachment either by an inhibition of the link reported. between CD34+ cells and stroma, or by inducing a stress to the hematopoietic system capable of favor- G-CSF, ing the egress of progenitor cells from marrow to Authors (ref.#) Donors dose/kg and CD34+ Apheresis circulation. The former is obtained by means of No. days of collected No. monoclonal antibodies directed against adhesion administration x 106 molecules,22 while the latter is based on the use of a Weaver (31) 4 16 µg, 4 d 9.6/kg 2 drug or a combination of drugs. Richman et al.23 Korbling (16) 9 12 µg, 7 d 13.1/kg 3 demonstrated for the first time in man that Bensinger (18) 8 16 µg, 6 d 13.1/kg 2 chemotherapy-induced cytopenia is followed by a Schmitz (17) 8 5-10 µg, 5-6 d 6.7/kg 1-3 substantial increase of CFU-C in blood.
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