Adipose tissue-derived stromal/stem cells + cholecalciferol: a pilot study in recent-onset type 1 diabetes patients.

Autor:	Dantas JR; Departamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil., Araújo DB; Departamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil., Silva KR; Laboratório de Bioengenharia de Tecidos, Instituto Nacional de Metrologia, Qualidade e Tecnologia (Inmetro), Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil., Souto DL; Departamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil, deboralopessouto@gmail.com., de Fátima Carvalho Pereira M; Serviço de Patologia Clínica, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil., Luiz RR; Instituto de Estudos de Saúde Pública, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil., Dos Santos Mantuano M; Faculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil., Claudio-da-Silva C; Departamento de Cirurgia Plástica, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil., Gabbay MAL; Universidade Federal de São Paulo, São Paulo, SP, Brasil., Dib SA; Universidade de São Paulo, São Paulo, SP, Brasil., Couri CEB; Departamento de Hematologia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil., Maiolino A; Departamento de Hematologia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil., Rebelatto CLK; Core Cell Technology, Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brasil., Daga DR; Core Cell Technology, Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brasil., Senegaglia AC; Core Cell Technology, Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brasil., Brofman PRS; Core Cell Technology, Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brasil., Baptista LS; Centro Multidisciplinar de Pesquisas Biológicas (Numpex-Bio), Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil; Laboratório de Bioengenharia de Tecidos, Instituto Nacional de Metrologia, Qualidade e Tecnologia (Inmetro), Rio de Janeiro, RJ, Brasil., de Oliveira JEP; Departamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil., Zajdenverg L; Departamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil., Rodacki M; Departamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil.
Jazyk:	angličtina
Zdroj:	Archives of endocrinology and metabolism [Arch Endocrinol Metab] 2021 Nov 03; Vol. 65 (3), pp. 342-351. Date of Electronic Publication: 2021 Apr 29.
DOI:	10.20945/2359-3997000000368
Abstrakt:	Objective: Adipose tissue-derived stromal/stem cells (ASCs) and vitamin D have immunomodulatory actions that could be useful for type 1 diabetes (T1D). We aimed in this study to investigate the safety and efficacy of ASCs + daily cholecalciferol (VIT D) for 6 months in patients with recent-onset T1D. Methods: In this prospective, dual-center, open trial, patients with recent onset T1D received one dose of allogenic ASC (1 × 10 6 cells/kg) and cholecalciferol 2,000 UI/day for 6 months (group 1). They were compared to patients who received chol-ecalciferol (group 2) and standard treatment (group 3). Adverse events were recorded; C-peptide (CP), insulin dose and HbA1c were measured at baseline (T0), after 3 (T3) and 6 months (T6). Results: In group 1 (n = 7), adverse events included transient headache (all), mild local reactions (all), tachycardia (n = 4), abdominal cramps (n = 1), thrombophlebitis (n = 4), scotomas (n = 2), and central retinal vein occlusion at T3 (n = 1, resolution at T6). Group 1 had an increase in basal CP (p = 0.018; mean: 40.41+/-40.79 %), without changes in stimulated CP after mixed meal (p = 0.62), from T0 to T6. Basal CP remained stable in groups 2 and 3 (p = 0.58 and p = 0.116, respectively). Group 1 had small insulin requirements (0.31+/- 0.26 UI/kg) without changes at T6 (p = 0.44) and HbA1c decline (p = 0.01). At T6, all patients (100%; n = 7) in group 1 were in honeymoon vs 75% (n = 3/4) and 50% (n = 3/6) in groups 2 and 3, p = 0.01. Conclusion: Allogenic ASC + VIT D without immunosuppression was safe and might have a role in the preservation of β-cells in patients with recent-onset T1D. ClinicalTrials.gov: NCT03920397.
Databáze:	MEDLINE
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