dc.creator | Trujillo Rodríguez, María | es |
dc.creator | Viciana, Pompeyo | es |
dc.creator | Rivas Jeremías, Inmaculada | es |
dc.creator | Álvarez Ríos, Ana I. | es |
dc.creator | Ruiz García, Antonio | es |
dc.creator | Espinosa Ibáñez, Olga | es |
dc.creator | López Cortés, Luis Fernando | es |
dc.date.accessioned | 2022-07-19T10:21:32Z | |
dc.date.available | 2022-07-19T10:21:32Z | |
dc.date.issued | 2021 | |
dc.identifier.citation | Trujillo Rodríguez, M., Viciana, P., Rivas Jeremías, I., Álvarez Ríos, A.I., Ruiz García, A., Espinosa Ibáñez, O. y López Cortés, L.F. (2021). Mesenchymal stromal cells in human immunodeficiency virus infected patients with discordant immune response: Early results of a phase I/II clinical trial. Stem cells translational medicine, 10 (4), 534-541. | |
dc.identifier.issn | 2157-6564 | es |
dc.identifier.issn | 2157-6580 | es |
dc.identifier.uri | https://hdl.handle.net/11441/135554 | |
dc.description.abstract | Between 15% and 30% of HIV-infected subjects fail to increase their CD4+ T-cell counts
despite continuous viral suppression (immunological nonresponders [INRs]). These subjects
have a higher morbidity and mortality rate, but there are no effective treatments to reverse
this situation so far. This study used data from an interrupted phase I/II clinical trial to evalu ate safety and immune recovery after INRs were given four infusions, at baseline and at
weeks 4, 8, and 20, with human allogeneic mesenchymal stromal cells from adipose tissue
(Ad-MSCs). Based on the study design, the first 5 out of 15 INRs recruited received
unblinded Ad-MSC infusions. They had a median CD4+ nadir count of 16/μL (range, 2-180)
and CD4+ count of 253 cells per microliter (171-412) at baseline after 109 (54-237) months
on antiretroviral treatment and 69 (52-91) months of continuous undetectable plasma HIV RNA. After a year of follow-up, an independent committee recommended the suspension of
the study because no increase of CD4+ T-cell counts or CD4+
/CD8+ ratios was observed.
There were also no significant changes in the phenotype of different immunological lympho cyte subsets, percentages of natural killer cells, regulatory T cells, and dendritic cells, the
inflammatory parameters analyzed, and cellular associated HIV-DNA in peripheral blood
mononuclear cells. Furthermore, three subjects suffered venous thrombosis events directly
related to the Ad-MSC infusions in the arms where the infusions were performed. Although
the current study is based on a small sample of participants, the findings suggest that alloge neic Ad-MSC infusions are not effective to improve immune recovery in INR patients or to
reduce immune activation or inflammation. ClinicalTrials.gov identifier: NCT0229004.
EudraCT number: 2014-000307-26. | es |
dc.description.sponsorship | Instituto de Salud Carlos III | es |
dc.description.sponsorship | Red de Investigación en SIDA | es |
dc.description.sponsorship | Andalusian Regional Ministry of Health and Families | es |
dc.format | application/pdf | es |
dc.format.extent | 9 p. | es |
dc.language.iso | eng | es |
dc.publisher | Wiley | es |
dc.relation.ispartof | Stem cells translational medicine, 10 (4), 534-541. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Clinical trial | es |
dc.subject | HIV infection | es |
dc.subject | Immunological nonresponders | es |
dc.subject | Mesenchymal stromal cells | es |
dc.title | Mesenchymal stromal cells in human immunodeficiency virus infected patients with discordant immune response: Early results of a phase I/II clinical trial | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.projectID | AES 2015; grant PI15/01041 | es |
dc.relation.projectID | RD16/0025/0020-ISCIII-FEDER | es |
dc.relation.publisherversion | https://academic.oup.com/stcltm/article/10/4/534/6404076 | es |
dc.identifier.doi | 10.1002/sctm.20-0213 | es |
dc.journaltitle | Stem cells translational medicine | es |
dc.publication.volumen | 10 | es |
dc.publication.issue | 4 | es |
dc.publication.initialPage | 534 | es |
dc.publication.endPage | 541 | es |