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The safety of systemic administration of bone marrow\u2010derived mononuclear cells (BMDMCs) has been shown in different preclinical models of kidney diseases. However, to date, no study has evaluated the safety and biodistribution of BMDMCs after infusion in renal arteries in patients with FSGS. We used a prospective, non\u2010randomized, single\u2010center longitudinal design to investigate this approach. Five patients with refractory FSGS and an estimated glomerular filtration rate (eGFR) between 20 and 40\u2009ml\/min\/1.73\u2009m<jats:sup>2<\/jats:sup> underwent bone marrow aspiration and received an arterial infusion of autologous BMDMCs (5\u2009\u00d7\u200910<jats:sup>7<\/jats:sup>) for each kidney. In addition, BMDMCs labeled with technetium\u201099m (<jats:sup>99m<\/jats:sup>Tc\u2010BMDMCs) were used to assess the biodistribution by scintigraphy. All patients completed the 270\u2010day follow\u2010up protocol with no serious adverse events. A transient increase in creatinine was observed after the cell therapy, with improvement on day 30. <jats:sup>99m<\/jats:sup>Tc\u2010BMDMCs were detected in both kidneys and counts were higher after 2\u2009hr compared with 24\u2009hr. The arterial infusion of BMDMCs in both kidneys of patients with FSGS was considered safe with stable eGFR at the end of follow\u2010up. This trial is registered with <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" xlink:href=\"https:\/\/clinicaltrials.gov\/ct2\/show\/NCT02693366\">NCT02693366<\/jats:ext-link>.<\/jats:p>","DOI":"10.1155\/2024\/2385568","type":"journal-article","created":{"date-parts":[[2024,7,9]],"date-time":"2024-07-09T13:31:21Z","timestamp":1720531881000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Safety and Biodistribution of an Autologous Bone Marrow\u2010Derived Mononuclear Cell Infusion into Renal Arteries in Patients with Focal Segmental Glomerulosclerosis: A Phase 1 Study"],"prefix":"10.1155","volume":"2024","author":[{"given":"Bruno Freire","family":"Botelho","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andr\u00e9 Luis","family":"Barreira","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcio Gomes","family":"Filippo","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Karina Dutra","family":"Asensi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lanuza A P","family":"Faccioli","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anna Beatriz","family":"dos Santos Salgado","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Elizabeth Figueiredo","family":"de Salles","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Carlos Eduardo Cruz","family":"Marques","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pedro Leme","family":"Silva","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Regina Coeli","family":"dos Santos Goldenberg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angelo","family":"Maiolino","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bianca","family":"Gutfilen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sergio Augusto Lopes","family":"de Souza","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maurilo Leite","family":"Junior","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3742-2050","authenticated-orcid":false,"given":"Marcelo Marcos","family":"Morales","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2024,7,9]]},"reference":[{"key":"e_1_2_13_1_2","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2016.03.416"},{"key":"e_1_2_13_2_2","doi-asserted-by":"publisher","DOI":"10.1093\/ndt\/gfp355"},{"key":"e_1_2_13_3_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMra1106556"},{"key":"e_1_2_13_4_2","doi-asserted-by":"publisher","DOI":"10.1080\/03007995.2017.1322567"},{"key":"e_1_2_13_5_2","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.08970719"},{"key":"e_1_2_13_6_2","doi-asserted-by":"publisher","DOI":"10.1155\/2014\/124730"},{"key":"e_1_2_13_7_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2019.100249"},{"key":"e_1_2_13_8_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.jcyt.2013.01.010"},{"key":"e_1_2_13_9_2","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2017070781"},{"key":"e_1_2_13_10_2","doi-asserted-by":"publisher","DOI":"10.1148\/radiol.2018180449"},{"key":"e_1_2_13_11_2","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCULATIONAHA.109.863084"},{"key":"e_1_2_13_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.expneurol.2009.10.010"},{"key":"e_1_2_13_13_2","first-page":"143","article-title":"Tradu\u00e7\u00e3o para a l\u00edngua portuguesa e valida\u00e7\u00e3o do question\u00e1rio gen\u00e9rico de avalia\u00e7\u00e3o de qualidade de vida SF-36 (Brasil SF-36) (Brazilian-Portuguese version of the SF-36. 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