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1.
Bull Cancer ; 107(12S): S193-S201, 2020 Dec.
Article in French | MEDLINE | ID: mdl-33187683

ABSTRACT

CAR T-cells are anti-cancer immunocellular therapy drugs that involve reprogramming the patient's T-cells using a transgene encoding a chimeric antigen receptor (CAR). Although CAR T-cells are cellular therapies, the organization for manufacturing and delivering these medicinal products is in many ways different from the one for hematopoietic cell grafts or donor lymphocyte infusions. The implementation of this innovative therapy is recent and requires close coordination between clinical teams, the therapeutic apheresis unit, the cell therapy unit, the pharmaceutical laboratory, and pharmacy. Apart from the regulatory texts, which are regularly modified, and the specific requirements of each pharmaceutical laboratory, there is currently no guide to help the centers initiating their activity and there is no specific indicator to assess the quality of the CAR T-cell activity in each center. The purpose of the current harmonization workshop is to clarify the regulatory prerequisites warranted for a center to have a CAR T-cell activity and to propose recommendations for implementing quality tools, in particular indicators, and allowing their sharing.


Subject(s)
Immunotherapy, Adoptive/standards , Quality Assurance, Health Care , Receptors, Chimeric Antigen , Accreditation , Congresses as Topic/organization & administration , France , Health Personnel/education , Humans , Immunotherapy, Adoptive/legislation & jurisprudence , Societies, Medical
2.
Bull Cancer ; 107(1S): S36-S43, 2020 Jan.
Article in French | MEDLINE | ID: mdl-31615648

ABSTRACT

Given the absence of consensus on oral feeding of patients undergoing allogeneic hematopoietic transplantation, the ninth workshops of practice harmonization of the Francophone Society of Bone Marrow Transplantation and Cellular Therapy (SFGM-TC) allocated one session to address this topic, especially during the hospitalization. A questionnaire was sent to all SFGM-TC pediatric and adult centers in order to investigate oral feeding practices. The results demonstrated a large disparity among centers regarding oral feeding. Here, we report our recommendations regarding the oral feeding after allogeneic hematopoietic cell transplantation in terms of quality, quantity and bacterial authorized load.


Subject(s)
Enteral Nutrition , Hematopoietic Stem Cell Transplantation , Allografts , Cooking , Diet , Enteral Nutrition/methods , Enteral Nutrition/standards , Food/adverse effects , Food/classification , Food/standards , Food Handling/standards , Food Microbiology , Food Preservation , Humans , Inpatients
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