51 research outputs found
Ten years after the first inspection of a candidate European centre, an EBMT registry analysis suggests that clinical is improved when hematopoietic SCT is performed in a Jacie accredited program
In 2010, JACIE, the Joint Accreditation Committee of
ISCT (International Society for Cell Therapy) Europe and
EBMT (European group for Blood and Marrow Transplantation)
celebrated the tenth anniversary of the first
inspection of a European hematopoietic SCT program.
JACIE standards establish the criteria for a comprehensive
quality management program that covers all three major
domains of activity that are necessary for the delivery of
HSCT: clinical, collection and processing, as well as their
interactions with ancillary and supportive activities.
Although more than 200 European programs have applied
for JACIE accreditation, and more than 100 have been
granted accreditation, a recent retrospective analysis of the
large-size EBMT registry of autologous and allogenic
hematopoietic HSCT demonstrates that one of the factors
affecting the overall survival of recipients of allogenic
transplantation is the status of the transplant program
regarding JACIE accreditation. This provides one of the
first demonstrations that introduction of a quality management
system contributes to the overall survival of patients
treated with a highly specific medical procedure, and
represents a milestone in the implementation of JACIE
High-dose carboplatin, thiotepa and cyclophosphamide (CTC) with peripheral blood stem cell support in the adjuvant therapy of high-risk breast cancer: a practical approach.
In 29 chemotherapy-naive patients with stage II-III breast cancer, peripheral blood stem cells (PBSCs) were mobilised following fluorouracil 500 mg m-2, epirubicin 90-120 mg m-2 and cyclophosphamide 500 mg m-2 (FEC) and granulocyte colony-stimulating factor (G-CSF; Filgrastim) 300 microgram s.c. daily. In all but one patient, mobilisation was successful, requiring three or fewer leucocytopheresis sessions in 26 patients; 28 patients subsequently underwent high-dose chemotherapy consisting of carboplatin 1600 mg m-2, thiotepa 480 mg m-2 and cyclophosphamide 6 g m-2 (CTC) followed by PBSC transplantation. Haemopoietic engraftment was rapid with a median time to neutrophils of 500 x 10(6) l(-1) of 9 days (range 8-10) in patients who received G-CSF after PBSC-transplantation; platelet transfusion independence was reached within a median of 10 days (range 7-16). Neutropenic fever occurred in 96% of patients. Gastrointestinal toxicity was substantial but reversible. Renal, neural or ototoxicity was not observed. Complications related to the central venous catheter were encountered in 64% of patients, with major vein thrombosis occurring in 18%. High-dose CTC-chemotherapy with PBSC-transplantation, harvested after mobilisation with FEC and G-CSF, is reasonably well tolerated without life-threatening toxicity and is a suitable high-dose strategy for the adjuvant treatment of breast cancer
Relationships between Hematopoiesis and Hepatogenesis in the Midtrimester Fetal Liver Characterized by Dynamic Transcriptomic and Proteomic Profiles
In fetal hematopoietic organs, the switch from hematopoiesis is hypothesized to be a critical time point for organogenesis, but it is not yet evidenced. The transient coexistence of hematopoiesis will be useful to understand the development of fetal liver (FL) around this time and its relationship to hematopoiesis. Here, the temporal and the comparative transcriptomic and proteomic profiles were observed during the critical time points corresponding to the initiation (E11.5), peak (E14.5), recession (E15.5), and disappearance (3 ddp) of mouse FL hematopoiesis. We found that E11.5-E14.5 corresponds to a FL hematopoietic expansion phase with distinct molecular features, including the expression of new transcription factors, many of which are novel KRAB (Kruppel-associated box)-containing zinc finger proteins. This time period is also characterized by extensive depression of some liver functions, especially catabolism/utilization, immune and defense, classical complement cascades, and intrinsic blood coagulation. Instead, the other liver functions increased, such as xenobiotic and sterol metabolism, synthesis of carbohydrate and glycan, the alternate and lectin complement cascades and extrinsic blood coagulation, and etc. Strikingly, all of the liver functions were significantly increased at E14.5-E15.5 and thereafter, and the depression of the key pathways attributes to build the hematopoietic microenvironment. These findings signal hematopoiesis emigration is the key to open the door of liver maturation
Applying extracellular vesicles based therapeutics in clinical trials - an ISEV position paper
Extracellular vesicles (EVs), such as exosomes and microvesicles, are released by different cell types and participate in physiological and pathophysiological processes. EVs mediate intercellular communication as cell-derived extracellular signalling organelles that transmit specific information from their cell of origin to their target cells. As a result of these properties, EVs of defined cell types may serve as novel tools for various therapeutic approaches, including (a) anti-tumour therapy, (b) pathogen vaccination, (c) immune-modulatory and regenerative therapies and (d) drug delivery. The translation of EVs into clinical therapies requires the categorization of EV-based therapeutics in compliance with existing regulatory frameworks. As the classification defines subsequent requirements for manufacturing, quality control and clinical investigation, it is of major importance to define whether EVs are considered the active drug components or primarily serve as drug delivery vehicles. For an effective and particularly safe translation of EV-based therapies into clinical practice, a high level of cooperation between researchers, clinicians and competent authorities is essential. In this position statement, basic and clinical scientists, as members of the International Society for Extracellular Vesicles (ISEV) and of the European Cooperation in Science and Technology (COST) program of the European Union, namely European Network on Microvesicles and Exosomes in Health and Disease (ME-HaD), summarize recent developments and the current knowledge of EV-based therapies. Aspects of safety and regulatory requirements that must be considered for pharmaceutical manufacturing and clinical application are highlighted. Production and quality control processes are discussed. Strategies to promote the therapeutic application of EVs in future clinical studies are addresse
17th Annual ISCT Meeting. May 18-21, 2011. Rotterdam
Cell therapy continues to grow at rapid pace and ISCT continues to be the premier global society promoting the principles
and practice of all areas within the vast arena of cell therapy. Every year, we gather at a wonderful destination around
the world to talk about our work, rekindle old friendships, and make new ones. These yearly events are the forum for us
to learn about new breakthroughs, and exchange our thoughts and ideas. This year Ineke, Massimo and Fred have done
an outstanding job in producing what promises to be the best meeting ever! We truly have something for everyone! The
plenary sessions will present the most outstanding science in cell therapy covering a wide array of topics from stem cells to
immunotherapy. You will hear about everything from the basic research in cell therapy to the translation this knowledge
into the clinics and, most importantly, how cell therapy is impacting the practice of medicine. The oral abstract sessions
highlight the very best \u201ccutting-edge\u201d science at the meeting and the poster sessions generate the informal exchanges
that stimulate the ideas which ultimately move the field forward. Our workshops provide the opportunity to discuss and
debate the controversies in the field leaving all participants with a broader view than when they arrived. We continue to
have a special track at the meeting focused on the cell processing technologists, the unsung heroes of cell therapy. We
pay special attention to the legal and regulatory issues that are required to move cell therapy into the clinics\u2026after all,
we are the translational cell therapy society
International Society for Cellular Therapy - 2nd European Meeting; Belgirate, Italy 11 - 14 September 2010
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