{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,28]],"date-time":"2026-03-28T15:18:35Z","timestamp":1774711115183,"version":"3.50.1"},"reference-count":35,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2014,3,11]],"date-time":"2014-03-11T00:00:00Z","timestamp":1394496000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Transfusion"],"published-print":{"date-parts":[[2014,7]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Autologous serum eye drops (<jats:styled-content style=\"fixed-case\">ASED<\/jats:styled-content>s) have been used to treat many eye diseases. However, there are no standardized guidelines for the production and quality control (<jats:styled-content style=\"fixed-case\">QC<\/jats:styled-content>) of <jats:styled-content style=\"fixed-case\">ASED<\/jats:styled-content>s in <jats:styled-content style=\"fixed-case\">K<\/jats:styled-content>orea. Our aim was to propose standardized guidelines for the production and <jats:styled-content style=\"fixed-case\">QC<\/jats:styled-content> of <jats:styled-content style=\"fixed-case\">ASED<\/jats:styled-content>s.<\/jats:p><\/jats:sec><jats:sec><jats:title>Study Design and Methods<\/jats:title><jats:p>We conducted a nationwide survey consisting of questions regarding the methods used in each hospital for the production and <jats:styled-content style=\"fixed-case\">QC<\/jats:styled-content> of <jats:styled-content style=\"fixed-case\">ASED<\/jats:styled-content>s. The survey was sent by e\u2010mail to 89 doctors responsible for the blood banks at different hospitals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Thirty\u2010two hospitals replied, and 13 hospitals reported using the <jats:styled-content style=\"fixed-case\">ASED<\/jats:styled-content>s in the treatment of patients with eye diseases. The screening test for patients, amount of blood sampling, type of bottle used for blood collection, details about the production of the eye drops, and storage methods and shelf life of unopened and opened bottles of eye drops varied between hospitals.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>Based on an analysis of the survey results and a review of the standard operating procedures and protocols for <jats:styled-content style=\"fixed-case\">ASED<\/jats:styled-content>s used in <jats:styled-content style=\"fixed-case\">J<\/jats:styled-content>apan, <jats:styled-content style=\"fixed-case\">G<\/jats:styled-content>ermany, <jats:styled-content style=\"fixed-case\">E<\/jats:styled-content>ngland and <jats:styled-content style=\"fixed-case\">W<\/jats:styled-content>ales, and the <jats:styled-content style=\"fixed-case\">U<\/jats:styled-content>nited <jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>tates, we proposed standardized guidelines for the production and <jats:styled-content style=\"fixed-case\">QC<\/jats:styled-content> of <jats:styled-content style=\"fixed-case\">ASED<\/jats:styled-content>s in <jats:styled-content style=\"fixed-case\">K<\/jats:styled-content>orea. <jats:styled-content style=\"fixed-case\">ASED<\/jats:styled-content>s are not cell therapy products in the strictest sense. However, because eye drops are composed of serum isolated from blood and are used in patients, we consider <jats:styled-content style=\"fixed-case\">ASED<\/jats:styled-content>s to be the basis for cell therapy products. Therefore, <jats:styled-content style=\"fixed-case\">ASED<\/jats:styled-content>s should be produced and stored according to standardized guidelines based on the <jats:styled-content style=\"fixed-case\">G<\/jats:styled-content>ood <jats:styled-content style=\"fixed-case\">M<\/jats:styled-content>anufacturing <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>ractice guidelines.<\/jats:p><\/jats:sec>","DOI":"10.1111\/trf.12558","type":"journal-article","created":{"date-parts":[[2014,3,12]],"date-time":"2014-03-12T02:46:56Z","timestamp":1394592416000},"page":"1864-1870","source":"Crossref","is-referenced-by-count":10,"title":["Proposal of standardized guidelines for the production and quality control of autologous serum eye drops in <scp>K<\/scp>orea: based on a nationwide survey"],"prefix":"10.1111","volume":"54","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-9175-6441","authenticated-orcid":false,"given":"Hye Ryun","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Laboratory Medicine Gyeongsang National University Hospital  Jinju Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yun Ji","family":"Hong","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University College of Medicine  Seoul Korea"},{"name":"Department of Laboratory Medicine Seoul National University Bundang Hospital  Seongnam Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soie","family":"Chung","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University Hospital Healthcare System Gangnam Center  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang Mee","family":"Hwang","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University College of Medicine  Seoul Korea"},{"name":"Department of Laboratory Medicine Seoul National University Bundang Hospital  Seongnam Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Taek Soo","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University College of Medicine  Seoul Korea"},{"name":"Department of Laboratory Medicine Seoul National University Bundang Hospital  Seongnam Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Eun Young","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University College of Medicine  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyoung Un","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University College of Medicine  Seoul Korea"},{"name":"Department of Laboratory Medicine Seoul National University Bundang Hospital  Seongnam Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Junghan","family":"Song","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University College of Medicine  Seoul Korea"},{"name":"Department of Laboratory Medicine Seoul National University Bundang Hospital  Seongnam Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kyou Sup","family":"Han","sequence":"additional","affiliation":[{"name":"Department of Laboratory Medicine Seoul National University College of Medicine  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2014,3,11]]},"reference":[{"key":"e_1_2_8_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/S1350-9462(99)00007-5"},{"key":"e_1_2_8_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.exer.2004.07.008"},{"key":"e_1_2_8_4_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1537-2995.2008.01665.x"},{"key":"e_1_2_8_5_1","doi-asserted-by":"publisher","DOI":"10.1006\/exer.1994.1145"},{"key":"e_1_2_8_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ophtha.2006.04.030"},{"key":"e_1_2_8_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1365-3148.2011.01072.x"},{"key":"e_1_2_8_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/art.1780270415"},{"key":"e_1_2_8_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0161-6420(99)90412-8"},{"key":"e_1_2_8_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bmt.1702334"},{"key":"e_1_2_8_11_1","doi-asserted-by":"publisher","DOI":"10.1038\/sj.bmt.1703862"},{"key":"e_1_2_8_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.2003.026211"},{"key":"e_1_2_8_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0002-9394(14)71962-2"},{"key":"e_1_2_8_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/00003226-200111000-00006"},{"key":"e_1_2_8_15_1","doi-asserted-by":"publisher","DOI":"10.1097\/00003226-200211000-00010"},{"key":"e_1_2_8_16_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.83.4.390"},{"key":"e_1_2_8_17_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.2004.044347"},{"key":"e_1_2_8_18_1","unstructured":"NHS Blood and Transplant.Autologous Serum Eyedrops Service.2008[cited 2013 May 20]. Available from:http:\/\/www.nhsbt.nhs.uk\/tissueservices\/pdf\/Autologous_Serum_Eyedrops_Service_leaflet%20_21_10_2008.pdf."},{"key":"e_1_2_8_19_1","first-page":"96","volume-title":"Transfusion Medicine","author":"Han KS","year":"2006"},{"key":"e_1_2_8_20_1","first-page":"250","volume-title":"Technical manual","author":"Fiebig EW","year":"2011"},{"key":"e_1_2_8_21_1","doi-asserted-by":"publisher","DOI":"10.1097\/00002030-200001280-00019"},{"key":"e_1_2_8_22_1","unstructured":"Code of federal regulations.Title 21 CFR Parts 610.Washington DC:US Government Printing Office;2013[cited 2013 May 20]. Available from:http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?fr=610.40"},{"key":"e_1_2_8_23_1","volume-title":"Standards for blood banks and transfusion services","author":"American Association of Blood Banks","year":"2012"},{"key":"e_1_2_8_24_1","unstructured":"Code of federal regulations.Title 21 CFR Parts 1271. Washington DC: US Government Printing Office;2013. [cited 2013 May 20]. Available from:http:\/\/www.accessdata.fda.gov\/scripts\/cdrh\/cfdocs\/cfcfr\/CFRSearch.cfm?CFRPart=1271"},{"key":"e_1_2_8_25_1","unstructured":"FACT\u2010JACIE.International standards for cellular therapy product collection processing and administration. 5th ed. Foundation for the Accreditation of Cellular Therapy (FACT);2012. [cited 2013 May 20]. Available from:http:\/\/www.factweb.org\/forms\/store\/ProductFormPublic\/search?action=1&Product_productNumber=621"},{"key":"e_1_2_8_26_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00417-004-1106-5"},{"key":"e_1_2_8_27_1","doi-asserted-by":"publisher","DOI":"10.1007\/s004170050034"},{"key":"e_1_2_8_28_1","doi-asserted-by":"publisher","DOI":"10.1136\/bjo.85.10.1188"},{"key":"e_1_2_8_29_1","doi-asserted-by":"publisher","DOI":"10.1097\/ICO.0b013e3181a2a7f6"},{"key":"e_1_2_8_30_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.farma.2010.02.004"},{"key":"e_1_2_8_31_1","doi-asserted-by":"publisher","DOI":"10.3109\/02713683.2012.720340"},{"key":"e_1_2_8_32_1","doi-asserted-by":"publisher","DOI":"10.1038\/eye.1995.17"},{"key":"e_1_2_8_33_1","doi-asserted-by":"publisher","DOI":"10.3109\/02713689308995769"},{"key":"e_1_2_8_34_1","first-page":"187","volume-title":"Technical manual","author":"Kakaiya R","year":"2011"},{"key":"e_1_2_8_35_1","doi-asserted-by":"publisher","DOI":"10.1097\/ICO.0b013e3182542085"},{"key":"e_1_2_8_36_1","unstructured":"International Council for Commonality in Blood BankingAutomation (ICCBBA). ISBT 128 Standard Labeling of Cellular Therapy Products v1.1.0.2013[cited 2013 May 20]. Available from:http:\/\/www.iccbba.org\/uploads\/1b\/56\/1b5616fd5468623434d2bba03c36172b\/ST\u2010004\u2010ISBT\u2010128\u2010Standard\u2010Labeling\u2010of\u2010Cellular\u2010Therapy\u2010Products\u2010v1.1.0.pdf"}],"container-title":["Transfusion"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Ftrf.12558","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/trf.12558","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,1]],"date-time":"2023-10-01T16:27:37Z","timestamp":1696177657000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/trf.12558"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,3,11]]},"references-count":35,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2014,7]]}},"alternative-id":["10.1111\/trf.12558"],"URL":"https:\/\/doi.org\/10.1111\/trf.12558","archive":["Portico"],"relation":{},"ISSN":["0041-1132","1537-2995"],"issn-type":[{"value":"0041-1132","type":"print"},{"value":"1537-2995","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,3,11]]}}}