{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T07:06:52Z","timestamp":1779088012033,"version":"3.51.4"},"reference-count":16,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2026,5,3]],"date-time":"2026-05-03T00:00:00Z","timestamp":1777766400000},"content-version":"vor","delay-in-days":32,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"},{"start":{"date-parts":[[2026,4,1]],"date-time":"2026-04-01T00:00:00Z","timestamp":1775001600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cytometry Pt A"],"published-print":{"date-parts":[[2026,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    We completed an international, multicenter, randomized, open\u2010label Phase I\/IIb trial assessing the safety and preliminary efficacy of transendocardial injection of autologous expanded CD34+ cells (ProtheraCytes) in patients after acute myocardial infarction (AMI; NCT02669810). A multicenter, randomized, controlled Phase III study is now being initiated. To support release of ProtheraCytes clinical batches, we validated two flow cytometry methods for accurate quantification of CD34\/CD45\n                    <jats:sup>+<\/jats:sup>\n                    cells (stem cell enumeration\u2014SCE method) and characterization of accessory leukocyte subsets (monocytes, granulocytes, and B, T, NK lymphocytes\u2014accessory populations immunophenotyping method). All the recovery rates for both methods, with calculations derived from QC materials specifications, met the acceptance criteria, based on precision assessment according to ICH Q2(R2), European Pharmacopeia (Ph. Eur. 2.7.23 and Ph. Eur. 2.7.24), and ISHAGE guidelines. In addition, the precision results (repeatability and intermediate precision) were lower than 28.3% (\u2264\u200930% for accessory populations immunophenotyping method) and lower than 13.5% (\u2264\u200925% for SCE method). Finally, a perfect linearity was demonstrated for SCE method across 1.7\u20132622.5\u2009cells\/\u03bcL with coefficient of determination (\n                    <jats:italic>R<\/jats:italic>\n                    <jats:sup>2<\/jats:sup>\n                    ) of linear regression above 0.99 and matrix effects nearly negligible for both methods. The specificity, precision and accuracy of these methods were proven in the analysis of six determinations per operator in three different series. Altogether, these results indicate a good accuracy and precision of the proposed methods determining absolute counts, viability, and proportions of live CD34\/CD45+ cells and accessory populations. This validated flow cytometry assay will be implemented for release testing in the forthcoming Phase III clinical trial of ProtheraCytes in post\u2010AMI patients.\n                  <\/jats:p>","DOI":"10.1002\/cyto.a.70028","type":"journal-article","created":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T03:16:53Z","timestamp":1777864613000},"page":"273-289","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Development and Validation of Flow Cytometry\u2010Based Method to Quantify\n                    <scp>CD34<\/scp>\n                    \/\n                    <scp>CD45<\/scp>\n                    + Cells as a Release Criterion of Clinical\u2010Grade Products for a Phase\n                    <scp>III<\/scp>\n                    Clinical Trial"],"prefix":"10.1002","volume":"109","author":[{"given":"Delphine","family":"Bouis","sequence":"first","affiliation":[{"name":"CellProthera SAS  Mulhouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Aur\u00e9lien","family":"Goubaud","sequence":"additional","affiliation":[{"name":"CellProthera SAS  Mulhouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Arthur","family":"Cormier","sequence":"additional","affiliation":[{"name":"CellProthera SAS  Mulhouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sara","family":"Bennaoum","sequence":"additional","affiliation":[{"name":"CellProthera SAS  Mulhouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Manon","family":"Destalminil","sequence":"additional","affiliation":[{"name":"CellProthera SAS  Mulhouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"H\u00e9l\u00e8ne","family":"Schaffhauser","sequence":"additional","affiliation":[{"name":"CellProthera SAS  Mulhouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christine","family":"Vignon","sequence":"additional","affiliation":[{"name":"CellProthera SAS  Mulhouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Matthieu","family":"de Kalbermatten","sequence":"additional","affiliation":[{"name":"CellProthera SAS  Mulhouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1830-6297","authenticated-orcid":false,"given":"Ibon","family":"Garitaonandia","sequence":"additional","affiliation":[{"name":"CellProthera SAS  Mulhouse France"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2026,5,3]]},"reference":[{"key":"e_1_2_11_2_1","doi-asserted-by":"publisher","DOI":"10.1002\/sctm.17\u20100277"},{"key":"e_1_2_11_3_1","doi-asserted-by":"publisher","DOI":"10.1002\/ehf2.15124"},{"key":"e_1_2_11_4_1","doi-asserted-by":"publisher","DOI":"10.3109\/14653240903164963"},{"key":"e_1_2_11_5_1","doi-asserted-by":"publisher","DOI":"10.1007\/s12015\u2010023\u201010643\u2010w"},{"key":"e_1_2_11_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/ejhf.1594"},{"key":"e_1_2_11_7_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41598\u2010023\u201047079\u20108"},{"key":"e_1_2_11_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ahj.2010.09.025"},{"key":"e_1_2_11_9_1","unstructured":"ICH Q2(R2) Guideline on Validation of Analytical Procedures Step 5 Revision 1 EMA\/CHMP\/ICH\/82072\/2006 Effective From 14 June 2024."},{"key":"e_1_2_11_10_1","unstructured":"ICH Q14 Guideline on Analytical Procedure Development Step 5 EMA\/CHMP\/ICH\/195040\/2022 Effective From 14 June 2024."},{"key":"e_1_2_11_11_1","unstructured":"European Pharmacopoeia 12 \u00a72.7.23 Numeration of CD34\/CD45+ in Haematopoietic Products (Ph. Eur. 2.7.23). accessed January 1 2020."},{"key":"e_1_2_11_12_1","unstructured":"European Pharmacopoeia 12 \u00a72.7.24 Flow Cytometry (Ph. Eur. 2.7.24). accessed July 1 2025."},{"key":"e_1_2_11_13_1","doi-asserted-by":"publisher","DOI":"10.1089\/scd.1.1996.5.213"},{"key":"e_1_2_11_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.a.23570"},{"key":"e_1_2_11_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.esmoop.2022.100645"},{"key":"e_1_2_11_16_1","doi-asserted-by":"publisher","DOI":"10.1002\/cyto.b.22180"},{"key":"e_1_2_11_17_1","doi-asserted-by":"publisher","DOI":"10.1002\/cpcy.53"}],"container-title":["Cytometry Part A"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cyto.a.70028","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1002\/cyto.a.70028","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1002\/cyto.a.70028","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,18]],"date-time":"2026-05-18T06:12:20Z","timestamp":1779084740000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1002\/cyto.a.70028"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,4]]},"references-count":16,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2026,4]]}},"alternative-id":["10.1002\/cyto.a.70028"],"URL":"https:\/\/doi.org\/10.1002\/cyto.a.70028","archive":["Portico"],"relation":{},"ISSN":["1552-4922","1552-4930"],"issn-type":[{"value":"1552-4922","type":"print"},{"value":"1552-4930","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,4]]},"assertion":[{"value":"2025-07-11","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-03-31","order":2,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2026-05-03","order":3,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}