Andreas Holbro1, Helen Baldomero2, Francesco Lanza3, Christian Chabannon4, John A Snowden5, Andreas Buser6, Laura Infanti6, Nina Worel7, Anna Sureda8, Manuela Badoglio9, Jakob Passweg2, Chiara Bonini10. 1. Blood Transfusion Center, Swiss Red Cross, Basel, Switzerland; Division of Hematology, University Hospital, Basel, Switzerland. Electronic address: andreas.holbro@usb.ch. 2. Division of Hematology, University Hospital, Basel, Switzerland. 3. Division of Hematology, Hospital of Ravenna, Ravenna, Italy. 4. Institut Paoli-Calmettes & Inserm CBT-1409, Centre d'Investigations Cliniques en Biothérapies, Aix-Marseille University, Marseille, France. 5. Joint Accreditation Committee International Society for Cellular Therapy (ISCT) and European Society for Blood and Marrow Transplantation (EBMT) (JACIE) Committee, Barcelona, Spain; Department of Haematology, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom. 6. Blood Transfusion Center, Swiss Red Cross, Basel, Switzerland; Division of Hematology, University Hospital, Basel, Switzerland. 7. Department of Blood Group Serology and Transfusion Medicine, Medical University Vienna, Vienna, Austria; JACIE EBMT Representative, JACIE Committee, Barcelona, Spain. 8. JACIE EBMT Representative, JACIE Committee, Barcelona, Spain; Institut Català d'Oncologia, Hospital Duran i Reynals, University Hospital Barcelona, Barcelona, Spain. 9. EBMT Data Office, Hôpital Saint Antoine, Paris, France. 10. Experimental Hematology, Università Vita-Salute San Raffaele, Milan, Italy.
Abstract
BACKGROUND: There is considerable heterogeneity in processing of stem cells for hematopoietic stem cell transplantation across Europe. The Foundation for the Accreditation of Cellular Therapy (FACT)-Joint Accreditation Committee International Society for Cellular Therapy and European Society for Blood and Marrow Transplantation (EBMT) (JACIE) standards provide minimum guidelines that, however, leave room for significant variations in practices at the individual transplantation center (TC). METHODS: To better understand the extent of heterogeneity in storage conditions, quality controls (QCs), graft processing and disposal, a questionnaire was developed, reviewed by the Cellular Therapy and Immunobiology Working Party (CTIWP) and sent to all EBMT TCs. RESULTS: In this study, 288 TCs from 46 countries (32 European, 14 associated) responded to the survey. Long-term storage is performed mainly either in liquid nitrogen or in the vapor phase of liquid nitrogen with 10% dimethyl sulfoxide (DMSO; 58% of centers). In case of microbiological contamination, most TCs make a case-by-case decision in collaboration with the clinicians. CD34+ counts are performed routinely either before and/or after thawing. Some centers perform additional QCs. DMSO is generally not removed (83%) and the graft is thawed at the bedside (68%) in a water bath (78%). There is heterogeneity between the centers regarding duration of storage and graft disposal. DISCUSSION: Overall, this survey demonstrates that the majority of responding TCs uses standardized procedures (intracenter standardization). However, significant intercenter variations persist, which warrant further standardization and investigations on clinical and financial consequences. Additionally, efforts should be undertaken to provide more specific international guidelines on storage duration and graft disposal, which may also have an important impact on health care services worldwide.
BACKGROUND: There is considerable heterogeneity in processing of stem cells for hematopoietic stem cell transplantation across Europe. The Foundation for the Accreditation of Cellular Therapy (FACT)-Joint Accreditation Committee International Society for Cellular Therapy and European Society for Blood and Marrow Transplantation (EBMT) (JACIE) standards provide minimum guidelines that, however, leave room for significant variations in practices at the individual transplantation center (TC). METHODS: To better understand the extent of heterogeneity in storage conditions, quality controls (QCs), graft processing and disposal, a questionnaire was developed, reviewed by the Cellular Therapy and Immunobiology Working Party (CTIWP) and sent to all EBMT TCs. RESULTS: In this study, 288 TCs from 46 countries (32 European, 14 associated) responded to the survey. Long-term storage is performed mainly either in liquid nitrogen or in the vapor phase of liquid nitrogen with 10% dimethyl sulfoxide (DMSO; 58% of centers). In case of microbiological contamination, most TCs make a case-by-case decision in collaboration with the clinicians. CD34+ counts are performed routinely either before and/or after thawing. Some centers perform additional QCs. DMSO is generally not removed (83%) and the graft is thawed at the bedside (68%) in a water bath (78%). There is heterogeneity between the centers regarding duration of storage and graft disposal. DISCUSSION: Overall, this survey demonstrates that the majority of responding TCs uses standardized procedures (intracenter standardization). However, significant intercenter variations persist, which warrant further standardization and investigations on clinical and financial consequences. Additionally, efforts should be undertaken to provide more specific international guidelines on storage duration and graft disposal, which may also have an important impact on health care services worldwide.