Haematopoietic stem cell transplantation Haematopoietic stem cell transplantation (HSCT) from allogeneic normal donors represent a powerful immunological tool to eradicate minimal residual neoplastic disease in hemato-oncological patients. In spite of demonstrated activity, HSCT is gravated by serious toxicity due to the immunodeficiency status induced in the patients. Severe infections and leukemia relapse represent two areas of major concern when standard immunosuppressive regimens are utilised in the recipient. Furthermore acute and chronic graft versus host disease often take place, causing important problems and even death of the patient. Finally leukeamia patients undergoing high dose chemotherapy and/or Campath-1H treatment are heavily immunodepressed, even without undergoing HSCT. With the aim of developing protocols to overcome these problems, we are presently exploring three main cellular therapy strategies:
1) T CD3/CD56 double positive population (CIK cells) are expanded in vitro in GMP conditions and given to patients for their anti-tumour activity. Indeed these cells show a considerable anti-tumour cytotoxic activity in vitro and in vivo in several pre-clinical models. A phase I/II clinical trial is in progress with these cells in relapsed patients after HSCT.
2) Large number of total T cells are expanded in vitro using anti-CD3/CD28 antibody stimulation to allow faster immune reconstitution of heavily immunodepressed patients after chemotherapy treatment.
3) Mesenchymal stromal cells (MSCs) are expanded in vitro for the treatment of graft versus host disease. These cells have been shown to have immunosuppressive properties and overcome GVHD.
The different cell therapy protocols are being optimised for cell expansion in GMP conditions. The cell products obtained have to be fully characterised. New protocols may be developed.
The Laboratory of Cellular and Gene Therapy “G. Lanzani” has been approved during 2007 by the Agenzia Italiana del Farmaco (AIFA) as a Cell Factory for the production of Cellular Therapy Products.
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