Adipose tissue-derived stromal/stem cells + cholecalciferol: a pilot study in recent-onset type 1 diabetes patients
ABSTRACT 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. Materials and methods: In this prospective, dual-center, open trial, patients with recent onset T1D received one dose of allogenic ASC (1 x 106 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. Conclusions: 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.
Main Authors: | Dantas,Joana Rodrigues, Araújo,Débora Batista, Silva,Karina Ribeiro, Souto,Débora Lopes, Pereira,Maria de Fátima Carvalho, Luiz,Ronir Raggio, Mantuano,Matheus dos Santos, Claudio-da-Silva,Cesar, Gabbay,Monica Andrade Lima, Dib,Sérgio Atala, Couri,Carlos Eduardo Barra, Maiolino,Angelo, Rebelatto,Carmen Lúcia Kuniyoshi, Daga,Débora Regina, Senegaglia,Alexandra Cristina, Brofman,Paulo Roberto Slud, Baptista,Leandra S., Oliveira,José Egídio Paulo de, Zajdenverg,Lenita, Rodacki,Melanie |
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Format: | Digital revista |
Language: | English |
Published: |
Sociedade Brasileira de Endocrinologia e Metabologia
2021
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Online Access: | http://old.scielo.br/scielo.php?script=sci_arttext&pid=S2359-39972021000300342 |
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