Cell therapy: cGMP facilities and manufacturing.

Advanced therapies constitute one of the most complex, organizational, and regulatory areas currently approached by clinical researchers in order to explore new therapeutic applications. Basic scientists and clinicians trying to implement cell therapies into clinical practice, may feel overwhelmed by the apparently endless regulatory requirements that apply. However, regulatory agencies have primary responsibility on patient safety and law enforcement are, and should be, their main considerations.

A multiple regression analysis on factors influencing haematopoietic progenitor cell collection for autologous transplantation.

Autologous hematopoietic stem cell (HSC) transplantation today is the standard treatment for a wide variety of haematological and oncological diseases. HSC are collected from peripheral blood by leukapheresis (HPC-A) following chemotherapy and/or growth factor-mediated mobilization. The ideal HPC-A collection allows to reach the CD34(+) target dose through a single, tailored leukapheresis.

Survey of current practice for monitoring and management of platelet refractoriness in Italy.

Platelet transfusion failure is a common phenomenon affecting from 7% to 34% of haematology-oncology patients. Monitoring the efficacy of platelet transfusion through the evaluation of a post-transfusion platelet count and clinical response represent an important guide for subsequent transfusions and for the detection of refractoriness. The aim of this survey was to investigate physicians' attitudes and practices regarding the monitoring of platelet response and the management of platelet refractoriness.

Comparison of ciprofloxacin, ofloxacin and pefloxacin for the prevention of the bacterial infection in neutropenic patients with haematological malignancies.

The efficacy of oral prophylaxis with ciprofloxacin, ofloxacin or pefloxacin was assessed in preventing bacterial infection in neutropenic patients with treatment being allocated randomly before beginning chemotherapy. Bacteraemia developed in six of 78 episodes (8%) treated with ciprofloxacin, in eight of 80 (10%) allocated to ofloxacin and in 12 of 77 (16%) when pefloxacin was given. However, there were no episodes involving Gram-negative bacilli among those given ciprofloxacin whereas three and seven episodes occurred in patients given ofloxacin or pefloxacin respectively (P = 0.

Rapid diagnosis of bacterial contamination of blood: comparison of three automated microbial detection systems.

Rapid methods of determining microbial contamination are needed in suspecting contaminated banked blood or other blood products. In this study, we experimented contaminated blood units with 122 strains of bacteria and fungi. After innoculation, a comparison between ESP Blood Culture System (Difco Laboratories Inc.

The role of hemapheresis technology in allogeneic bone marrow transplantation.

In this paper the impact of hemapheresis technology on 238 allogeneic bone marrow transplants performed in Pescara from 1982 through 1993 is described. Granulocyte transfusions were limited to patients with neutrophil level < 0.2 x 10(9)/L.