{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,6,9]],"date-time":"2025-06-09T13:47:20Z","timestamp":1749476840675,"version":"3.40.5"},"reference-count":43,"publisher":"Wiley","issue":"3","license":[{"start":{"date-parts":[[2022,3,20]],"date-time":"2022-03-20T00:00:00Z","timestamp":1647734400000},"content-version":"vor","delay-in-days":19,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2022,3]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>The AABB\u2010ISCT Joint Working Group Stability Project Team (SPT) was assigned to roadmap a path toward standardization of cryopreserved hematopoietic stem\/progenitor cell (HSPC) stability programs. HSPC stability encompasses a broad scope of conditions including non\u2010frozen (\u201cfresh\u201d) and cryopreserved cell products, and varying methods for storage, thaw, and administration. This report assessed current practices and focused solely on cryopreserved HSPC cell therapy products to establish preliminary recommendations for a stability program roadmap.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A survey was prepared by the SPT and distributed to ISCT and AABB members. Survey results were summarized and recommendations were outlined based on the responses from the survey. This report highlights current practices for cryopreserved HSPC stability programs, including additional considerations and recommendations.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results and Discussion<\/jats:title><jats:p>Eighty\u2010two (82) centers worldwide participated in the survey. Survey results indicate variability across programs. HSPC stability depends on multiple factors within the processing facility (e.g., cryopreservation techniques, reagents used, and storage temperature) and independent variables (e.g., donor\u2010related factors and starting material variability). While retention of hematopoietic engraftment potential is the primary goal for cryopreserved HSPC stability, engraftment results should not be used as the sole metric for stability programs. Based on the survey results, the SPT provides recommendations for consideration.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>The SPT recommendations for best practices are not intended to replace existing standards. The survey results emphasize the need for the community to optimize best practices and consider initiating collaborative projects to improve the standardization of cryopreserved HSPC stability programs for cell therapy products.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.16820","type":"journal-article","created":{"date-parts":[[2022,3,21]],"date-time":"2022-03-21T04:00:11Z","timestamp":1647835211000},"page":"651-662","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["Cryopreserved hematopoietic stem\/progenitor cells stability program\u2010development, current status and recommendations: A brief report from the AABB\u2010ISCT joint working group cellular therapy product stability project team"],"prefix":"10.1111","volume":"62","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9628-2932","authenticated-orcid":false,"given":"Ronit","family":"Reich\u2010Slotky","sequence":"first","affiliation":[{"name":"John Theurer Cancer Center Hackensack University Medical Center  Hackensack New Jersey USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-7759-4546","authenticated-orcid":false,"given":"Ljiljana V.","family":"Vasovic","sequence":"additional","affiliation":[{"name":"Weill Cornell Medicine New York\u2010Presbyterian Hospital  New York New York USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-9652-1617","authenticated-orcid":false,"given":"Kevin J.","family":"Land","sequence":"additional","affiliation":[{"name":"Vitalant Biotherapies  Phoenix Arizona USA"},{"name":"University of Texas Health Science Center San Antonio, Department of Pathology Transfusion Medicine  San Antonio Texas USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Mike","family":"Halpenny","sequence":"additional","affiliation":[{"name":"Canadian Blood Services  Ottawa Ontario Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joan","family":"Woeltz","sequence":"additional","affiliation":[{"name":"Blood &amp; Marrow Transplantation and Cellular Therapy Stanford Health Care  Stanford California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aby J.","family":"Mathew","sequence":"additional","affiliation":[{"name":"BioLife Solutions, Inc.  Bothell Washington USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Diane","family":"Fournier","sequence":"additional","affiliation":[{"name":"H\u00e9ma\u2010Qu\u00e9bec  Montreal Quebec Canada"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Brenda","family":"Alder","sequence":"additional","affiliation":[{"name":"Northside Hospital, Blood and Marrow Transplant Program, Cell Therapy Lab  Atlanta Georgia USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karl","family":"Stasko","sequence":"additional","affiliation":[{"name":"Dana\u2010Farber Cancer Institute Cell Manipulation Core Facility  Boston Massachusetts USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3113-9155","authenticated-orcid":false,"given":"Nadim","family":"Mahmud","sequence":"additional","affiliation":[{"name":"Division of Hematology\/Oncology, Department of Medicine University of Illinois College of Medicine  Chicago Illinois USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2022,3,20]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1038\/bmt.2013.176"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.12006"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcyt.2014.02.005"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1002\/jca.21914"},{"key":"e_1_2_8_6_1","unstructured":"Code of federal regulation Human cells tissues and cellular and tissue\u2010based products. Title 21 CFR Part 1271. In. Washington DC: US Government Printing Office; 2020 (revised annualy)."},{"key":"e_1_2_8_7_1","unstructured":"Code of federal regulation. Current good manufacturing practice in manufcturing processing packing or holding of drugs. Title 21 CFR Part 210. In. Washington DC: US Government Printing Office; 2020 (revised annually)."},{"key":"e_1_2_8_8_1","unstructured":"Code of federal regulation. Current good manufacturing practice for finished pharmaceuticals. Title 21 CFR Part 211. In. Washington DC: US Government Printing Office; 2020 (revised annually)."},{"key":"e_1_2_8_9_1","unstructured":"Code of federal regulation. General biological product standards. title 21 CFR Part 610. In. Washington DC: US Government Printing Office; 2020 (revised annually)."},{"volume-title":"And administration","year":"2021","key":"e_1_2_8_10_1"},{"volume-title":"Standards for cellular therapy services","year":"2021","key":"e_1_2_8_11_1"},{"key":"e_1_2_8_12_1","unstructured":"Guidance for Industry. Q1A(R2) Stability Testing of New Drug Substances and Products. In. Rockville MD: U.S. Department of Health and Human Services FDA CDER CBER; November 2009."},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2011-01-330514"},{"issue":"1","key":"e_1_2_8_14_1","first-page":"45","article-title":"High\u2010efficiency recovery of immature haematopoietic progenitor cells with extensive proliferative capacity from human cord blood cryopreserved for 10\u2009years","volume":"107","author":"Broxmeyer HE","year":"1997","journal-title":"Clin Exp Immunol"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1002\/ajh.20707"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1089\/scd.1.1996.5.213"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/(SICI)1097-0320(19980415)34:2<61::AID-CYTO1>3.0.CO;2-F"},{"key":"e_1_2_8_18_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transproceed.2009.06.191"},{"key":"e_1_2_8_19_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.onc.1207941"},{"key":"e_1_2_8_20_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcyt.2012.11.013"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2012.03650.x"},{"key":"e_1_2_8_22_1","doi-asserted-by":"publisher","DOI":"10.2174\/157488808786734006"},{"key":"e_1_2_8_23_1","doi-asserted-by":"publisher","DOI":"10.1016\/0011-2240(89)90016-3"},{"issue":"3","key":"e_1_2_8_24_1","first-page":"203","article-title":"Processing and storage of human bone marrow: a survey of current practices in North America","volume":"6","author":"Areman EM","year":"1990","journal-title":"Bone Marrow Transplant"},{"key":"e_1_2_8_25_1","first-page":"523","article-title":"Cryopreservation and storage of human bone marrow: a survey of current practices","volume":"333","author":"Areman EM","year":"1990","journal-title":"Prog Clin Biol Res"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bmt.1700644"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00277-014-2112-2"},{"volume-title":"Banking, and release for Administartion","year":"2019","key":"e_1_2_8_28_1"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-1759(00)00232-5"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1038\/cdd.2008.150"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2011.03305.x"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1155\/2013\/823912"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2007.001028.x"},{"key":"e_1_2_8_34_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcyt.2019.10.009"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bmt.1704247"},{"key":"e_1_2_8_36_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1423-0410.2007.01009.x"},{"volume-title":"Contemporary Bone Marrow Transplantation. Organ and Tissue Transplantation","author":"Mahmud N","key":"e_1_2_8_37_1"},{"key":"e_1_2_8_38_1","doi-asserted-by":"publisher","DOI":"10.1182\/blood-2019-132145"},{"key":"e_1_2_8_39_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.14777"},{"key":"e_1_2_8_40_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1537-2995.1996.36111297091743.x"},{"key":"e_1_2_8_41_1","doi-asserted-by":"publisher","DOI":"10.1089\/152581600319379"},{"key":"e_1_2_8_42_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bmt.1703575"},{"key":"e_1_2_8_43_1","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2257.1999.00253.x"},{"key":"e_1_2_8_44_1","doi-asserted-by":"publisher","DOI":"10.1111\/trf.15220"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.16820","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/trf.16820","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.16820","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,25]],"date-time":"2023-08-25T08:38:47Z","timestamp":1692952727000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.16820"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,3]]},"references-count":43,"journal-issue":{"issue":"3","published-print":{"date-parts":[[2022,3]]}},"alternative-id":["10.1111\/trf.16820"],"URL":"https:\/\/doi.org\/10.1111\/trf.16820","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"type":"print","value":"0041-1132"},{"type":"electronic","value":"1537-2995"}],"subject":[],"published":{"date-parts":[[2022,3]]},"assertion":[{"value":"2021-12-03","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-01-25","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2022-03-20","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}