Chimeric Antigen Receptor-T cells (CAR-T) are considered novel biological agents, designed to selectively attack cancer cells expressing specific antigens, with demonstrated clinical activity in patients affected with relapsed/refractory B-cell malignancies. In consideration of their complexity, the use of CAR-T requires dedicated clinical setting and health care practitioners with expertise in the selection, treatment, and management of toxicities and side effects. Such issue appears particularly important when contextualized in the rapid progress of CAR-T cell treatment, translating into a constant need of updating and evolution. Moreover, the clinical grade manufacturing of CAR-T cells is complex and implies articulated regulatory and organizational aspects. The main goal of this review is to summarize and provide an accurate analysis of the clinical, logistic, and regulatory requirements of CAR-T cell centers. Finally, we describe a new occupational figure called "CAR-T specialist" devoted to the establishment and coordination of the required facilities and regulatory landscape in the context of cancer centers.
Therapeutic apheresis (TA) includes a wide range of therapeutic procedures based on the separation of blood components and the collection of cells with therapeutic activity or the removal of unwanted plasma or cellular components involved in the etiology of various hematologic, renal, neurological, and medical diseases. The complexity of these interventions requires an organizing model to assure a proper clinical environment, technology, quality requirements, and personnel as well as an active system for outcome monitoring for safety and efficacy. Finally, a structured organizing model may favor the efficiency of the TA unit and economic affordability. Here, we describe the more relevant characteristics of a model of TA standards, named TA unit (TAU) standards, that may help to establish a quality program in units working in the field of TA (shown as supplementary material and available at http://www.ifeit.org/pdf/TAU_Standards_3.0.pdf.
Autologous stem cell transplantation (ASCT) is a standard treatment for many hematological disorders. Since ASCT needs technical and professional skills, a start-up process should imply the application of a specific methodology to reduce time and costs, and to optimize the results. We describe here an innovative and integrated process leading to the start-up of a transplant activity in the Hematology Unit of the general hospital of Frosinone, southern Lazio, Italy. The method had previously been employed successfully by one of us in a critical context (Mediterr J Hematol Infect Dis. 2017 Apr 15;9). Since 1996, the Hematology Unit in Frosinone gained experience in treating malignant and non malignant disorders, but HSCT could not be performed so patients were referred to other institutions in the country with remarkable costs and discomfort. The innovative aspect of our project is the application of a capacity building methodology aimed at establishing a quality system prior to the initiation of the clinical transplant activity. Capacity building is a continuous process addressed to individuals, organizations and institutions aiming at developing abilities and achieve objectives. A preliminary step was to check sustainability,ie whether the institution was suitable to support an ASCT activity, and to assess the level of expertise of the medical and nurse staff involved in the process. In fact, our Hospital was lacking some of the facilities required to perform ASCT, such as apheresis and stem cell manipulation. To overcome the obstacle, an agreement with the close Latina Hospital that has consolidated experience in ASCT was established, gaining access to their facilities and expertise. In June 2018 we held a first training course addressed to physicians and nurses that covered different aspects of ASCT. A scientific advisor led the process of editing clinical protocols and procedures. Simultaneously a quality system was built based on clinical guidelines that follow the international FACT-JACIE standards. In this phase, the document management system, the outcome indicators and the main rules of the transplant program were created. In order to improve the educational program we planned a second training phase based on on-site coaching. To better accomplish the task, physicians and nurses are now asked to highlight the practical aspects of the process that require further development trough a simple questionnaire. During this second training phase, selected physicians and nurses with experience in transplantation will undertake an open discussion about the aspects requiring further evaluation. The goal is to perform our first autologous transplant within four months since the start of the project. We believe that the capacity building process through on-site training and coaching represents an innovative effective method for developing autonomous skills needed to conduct a sustainable HSCT program. Disclosures No relevant conflicts of interest to declare.
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