Adult stem/progenitor cells are found in different human tissues. An in vitro cell culture is needed for their isolation or for their expansion when they are not available in a sufficient quantity to regenerate damaged organs and tissues. The level of complexity of these new technologies requires adequate facilities, qualified personnel with experience in cell culture techniques, assessment of quality and clear protocols for cell production. The rules for the implementation of cell therapy centers involve national and international standards of good manufacturing practices. However, such standards are not uniform, reflecting the diversity of technical and scientific development. Here standards from the United States, the European Union and Brazil are analyzed. Moreover, practical solutions encountered for the implementation of a cell therapy center appropriate for the preparation and supply of cultured cells for clinical studies are described. Development stages involved the planning and preparation of the project, the construction of the facility, standardization of laboratory procedures and development of systems to prevent cross contamination. Combining the theoretical knowledge of research centers involved in the study of cells with the practical experience of blood therapy services that manage structures for cell transplantation is presented as the best potential for synergy to meet the demands to implement cell therapy centers.

Gemtuzumab Ozogamicina (GO) é um derivado semi-sintético de caliqueamicina, um antibiótico citotóxico ligado a um anticorpo monoclonal direcionado contra antígeno CD33 presente nos mieloblastos leucêmicos. O objetivo deste trabalho é avaliar os efeitos colaterais, remissão e a sobrevida de 11 pacientes com leucemia mielóide aguda que utilizaram GO. A maior toxicidade foi atribuída à mielossupressão, a qual esteve presente em todos os pacientes. Um paciente foi a óbito devido a doença hepática veno-oclusiva. Quatro pacientes utilizaram a droga para tratamento de recaída e dois atingiram remissão parcial. Dois pacientes utilizaram a droga para tratamento de doença refratária e um atingiu remissão completa com 12 meses de sobrevida. GO foi utilizada para consolidação de cinco pacientes. Acreditamos que a droga é segura e pode ser uma opção para pacientes que não toleram os esquemas quimioterápicos tradicionais.

Gemtuzumab Ozogamicin consists of a semisynthetic derivate of calicheamicin, a cytotoxic antibiotic linked to a recombinant monoclonal antibody directed against the CD33 antigen present on leukemic myeloblasts. The aim of this report is to evaluate the side effects, remission and survival of 11 patients with acute myeloid leukemia that took Gemtuzumab Ozogamicin. The major toxicity was myelosuppression that was seen in all the patients. One patient died due to hepatic veno-occlusive disease. Four patients used the drug for relapse and two achieved partial remission. Two patients used the drug for refractory disease and one achieved complete remission with 12 months survival. Gemtuzumab Ozogamicin was also used for the consolidation therapy of 5 patients. We believe that Gemtuzumab Ozogamicin is safe and is an alternative for patients that do not respond to conventional therapy.

Gentuzumab Ozogamicina (GO) (Mylotarg®) tem como alvo células leucêmicas que expressam CD33 através de um anticorpo monoclonal conjugado a um agente citotóxico, a caliqueamicina. Esta droga foi aprovada para uso em pacientes idosos com leucemia mielóide aguda (LMA) recaída ou refratária e hepatotoxicidade é comum após sua administração. Tack e colaboradores apresentaram o primeiro caso de doença hepática veno-oclusiva (DHVO) após infusão de GO em um paciente que tinha realizado transplante de medula( TMO) há 8 meses. Três estudos de fase II com 188 pacientes com LMA foram analisados e a incidência de HVOD fatal foi inferior a 1%, sendo a realização de TMO o fator de risco mais importante. O objetivo deste artigo é relatar um caso raro de DHVO fatal com ruptura de veia e artéria hepática em um paciente de 68 anos que recebeu GO. Acreditamos que este é o primeiro relato de HVOD com ruptura de vasos hepáticos relacionado ao uso de GO.

Gemtuzumab Ozogamicin (Mylotarg®) targets leukemia cells expressing the CD 33 receptor by means of a monoclonal antibody conjugated to a cytotoxic agent, calicheamicin. It was approved for use in elderly patients with relapsed or refractory acute myeloid leukemia and reversible hepatotoxicity is common after administration. The first case of hepatic veno-occlusive disease was reported after Gemtuzumab Ozogamicin infusion in a patient who had been submitted to hematopoietic stem cell transplantation 8 months earlier. Three phase 2 studies with 188 patients with acute myeloid leukemia in first relapse that used Gemtuzumab Ozogamicin were analysed and the incidence of fatal hepatic veno-occlusive disease in these studies was < 1%, and prior hematopoietic stem cell transplantation was the most significant risk factor. The aim of this paper is to report a rare fatal case of hepatic veno-occlusive disease with rupture of the spleen vein and artery in a 68-year-old patient that had received Gemtuzumab Ozogamicin. To the best of our knowledge, it is the first case report of hepatic veno-occlusive disease with rupture of the spleen vein and artery related to Gemtuzumab Ozogamicin.