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Safety and Preliminary Efficacy of Mesenchymal Stromal Cell (ORBCEL-M) Therapy in Diabetic Kidney Disease: A Randomized Clinical Trial (NEPHSTROM).
Perico N, Remuzzi G, Griffin MD, Cockwell P, Maxwell AP, Casiraghi F, Rubis N, Peracchi T, Villa A, Todeschini M, Carrara F, Magee BA, Ruggenenti PL, Rota S, Cappelletti L, McInerney V, Griffin TP, Islam MN, Introna M, Pedrini O, Golay J, Finnerty AA, Smythe J, Fibbe WE, Elliman SJ, O'Brien T; NEPHSTROM Trial Consortium. Perico N, et al. J Am Soc Nephrol. 2023 Oct 1;34(10):1733-1751. doi: 10.1681/ASN.0000000000000189. Epub 2023 Aug 10. J Am Soc Nephrol. 2023. PMID: 37560967 Clinical Trial.
Novel topical allogeneic bone-marrow-derived mesenchymal stem cell treatment of hard-to-heal diabetic foot ulcers: a proof of concept study.
Askø Andersen J, Rasmussen A, Frimodt-Møller M, Engberg S, Steeneveld E, Kirketerp-Møller K, O'Brien T, Rossing P. Askø Andersen J, et al. Among authors: steeneveld e. Stem Cell Res Ther. 2022 Jun 28;13(1):280. doi: 10.1186/s13287-022-02951-8. Stem Cell Res Ther. 2022. PMID: 35765085 Free PMC article. Clinical Trial.
Good Manufacturing Practice-compliant human induced pluripotent stem cells: from bench to putative clinical products.
Novoa JJ, Westra IM, Steeneveld E, Fonseca Neves N, Arendzen CH, Rajaei B, Grundeken E, Yildiz M, van der Valk W, Salvador A, Carlotti F, Dijkers PF, Locher H, van den Berg CW, Raymond KI, Kirkeby A, Mummery CL, Rabelink TJ, Freund C, Meij P, Wieles B. Novoa JJ, et al. Among authors: steeneveld e. Cytotherapy. 2024 Mar 5:S1465-3249(24)00070-7. doi: 10.1016/j.jcyt.2024.02.021. Online ahead of print. Cytotherapy. 2024. PMID: 38483359 Free article.
Validating human induced pluripotent stem cell-specific quality control tests for the release of an intermediate drug product in a Good Manufacturing Practice quality system.
Novoa J, Westra I, Steeneveld E, Neves NF, Daleman L, Asensio AB, Davis RP, Carlotti F, Freund C, Rabelink T, Meij P, Wieles B. Novoa J, et al. Among authors: steeneveld e. Cytotherapy. 2024 Apr 14:S1465-3249(24)00610-8. doi: 10.1016/j.jcyt.2024.04.004. Online ahead of print. Cytotherapy. 2024. PMID: 38703154 Free article.