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1 storage and handling of unused stem cell products Swiss consensus? 16. Jan Panagiotis Samaras, Mario Bargetzi

2 stored units USZ

3 Type of unused product autologous stem cells never transplanted 2nd transplant (tandem, relapse) autologous back up in allogeneic transplanted patients donor lymphocytes (DLI) directed/targeted cord blood engineered cells (mesenchymal, NK)

4 patient related reasons for unused products response after first HD-chemotherapy disease progression prior to stem cell transplantation age of the patient deceased patients

5 Poll in Swiss centers

6 recomendations there should be a written policy dealing with storage, disposal and use for research purposes of unused stem cell products this policy should be part of the informed consent for high dose chemotherapy and stem cell transplantation, handed to the patient before collection of stem cells unused stem cell products of deceased patients should be disposed of for patients alive the duration of storage of unused stem cells should be at least 5 years disposal after 5 years of storage should only be done after discussion with the treating physician advanced age by itself is not a reason to discard unused stem cells Comorbidities, that preclude high dose chemotherapy and stem cell transplantation are a reason to discard unused stem cells storage duration should not be different for different diseases unused autologous back ups can be discarded after 5 years??? DLI??? stored unlimited instead of disposal unused stem cells can be used for research, if patient gave informed consent

7 Questionnaire Stem Cell Storage in Swiss Centers time period from 01/2004 to 12/2013 How many and what patients had long-term stored bags after rainy day collection (>1 year) before their first ASCT? ASCT after 1 to 5 years of storage (n, % of all stored products)? 0, 6 Entities of these transplanted patients? Lymphoma, solid tumors, AML? Patient Age? ASCT after 6 to 10 years of storage (n, % of all stored products)? 0, 1 Ly Entities of these transplanted patients? Patient age? ASCT after 10 years of storage (n, % of all stored products)? 0 Entities of these transplanted patients? Patient age?

8 How many and what patients had long-term stored bags after rainy day collection (>1 year) and NEVER received an ASCT? Storage for 1 to 5 years (n, % of all stored products)? 30 (Ly, AML, MM, Tu) Entities of these never-transplanted patients? Patient age? Storage for 6 to 10 years (n, % of all stored products)? 43 (Ly, AML, MM, Tu) Entities of these never-transplanted patients? Patient age? Storage for over 10 years (n, % of all stored products)? 15 (Ly, AML, MM, Tu) Entities of these never-transplanted patients? Patient age?

9 How many patients received a second transplant as salvage with stored bags? 1-5 years after the first ASCT? 14, 38 Entities? All MM Patient age? Mean 55 (range 27 67) at 1 st transplant 6-10 years after the first ASCT? 2, 3 Entities? All MM Patient age? 57, 58 at 1 st transplant >10 years after the first ASCT? 0

10 How many patients NEVER received a second transplant as salvage and have still bags? Storage for 1-5 years after the first ASCT? 33, 48 Entities? MM, (1Ly, 1 Tu) Patient age? Mean 56.2 y (range 37 68) Storage for 6-10 years after the first ASCT? 14, 43 Entities? MM, (2 Tu) Patient age? Mean 59.4 (range 47 69) Storage for >10 years after the first ASCT? 0, 3 Entities? MM Patient age?

11 What patients had their bags disposed at that time period? Entities? 22, 100 patients, all MM, > 90 % death, < 10 % >7y Reasons for disposal (i.e. death, age of patient, age of bag, contraindications for ASCT, Damaged bag, other reason)? Transplanted or NEVER transplanted patient? All transplanted

12

13 27 % units unused at follow up > 3 years 41 % of patients reinfused with all units < 1 % after 2 years of storage before transplantation in leukemia < 2 % in patients with myeloma or lymphoma

14

15 we should finally get there please send all data thank you

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