Produção Nacional
Revisado por pares
Allogenic Adipose Tissue-Derived Stromal/Stem Cells and Vitamin D Supplementation in Patients With Recent-Onset Type 1 Diabetes Mellitus: A 3-Month Follow-Up Pilot Study
2020; Frontiers Media; Volume: 11; Linguagem: Inglês
10.3389/fimmu.2020.00993
ISSN1664-3224
AutoresDébora Batista Araújo, Joana Rodrigues Dantas, Karina Ribeiro Silva, Débora Lopes Souto, Maria de Fátima Carvalho Pereira, Jéssica Pronestino de Lima Moreira, Ronir Raggio Luiz, César Claudio-da-Silva, Mônica Andrade Lima Gabbay, Sérgio Atala Dib, Carlos Eduardo Barra Couri, Ângelo Maiolino, Cármen Lúcia Kuniyoshi Rebelatto, Débora Regina Daga, Alexandra Cristina Senegaglia, Paulo Roberto Slud Brofman, Leandra Santos Baptista, José Egídio Paulo de Oliveira, Lenita Zajdenverg, Melanie Rodacki,
Tópico(s)Diabetes Management and Research
ResumoOBJECTIVE: To evaluate the short term safety and potential therapeutic effect of allogenic adipose tissue-derived stromal/stem cells (ASCs) + cholecalciferol in patients with recent-onset T1D. METHODS: Prospective, phase II, open trial, pilot study in which patients with recent onset T1D received ASCs (1x106 cells/kg) and cholecalciferol 2000UI/day for 3 months (group 1) and were compared to controls with standard insulin therapy (group 2). Adverse events, C-peptide (CP), insulin dose, HbA1c, time in range (TIR), glucose variability (continuous glucose monitoring) and frequency of CD4+FoxP3+ T-cells (flow cytometry) were evaluated at baseline (T0) and after 3 months (T3). RESULTS: 13 patients were included (8: group 1; 5: group 2). Their mean age and disease duration were 26.7 ± 6.1 years and 2.9 ± 1.05 months. Adverse events were transient headache (n=8), mild local reactions (n=7), tachycardia (n=4), abdominal cramps (n=1), thrombophlebitis (n=4), mild floaters (n=2), central retinal vein occlusion (n=1, complete resolution). At T3, group 1 had lower insulin requirement (0.22±0.17 vs 0.61±0.26IU/Kg; p=0.01) and HbA1c (6.47±0.86 vs 7.48±0.52%; p=0.03) than group 2. In group 1, 2 patients became insulin free (for 4 and 8 weeks) and all were in honeymoon at T3 (vs none in group 2; p=0.01). CP variations did not differ between groups (-4.6 ± 29.1% vs +2.3 ± 59.65%; p=0.83). CONCLUSIONS: Allogenic ASCs + cholecalciferol without immunosuppression was associated with stability of CP and unanticipated mild transient adverse events in patients with recent onset T1D. ClinicalTrials.gov registration: NCT03920397.
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