Archives of Endocrinology and Metabolism (May 2021)

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

  • Joana Rodrigues Dantas,
  • Débora Batista Araújo,
  • Karina Ribeiro Silva,
  • Débora Lopes Souto,
  • Maria de Fátima Carvalho Pereira,
  • Ronir Raggio Luiz,
  • Matheus dos Santos Mantuano,
  • Cesar Claudio-da-Silva,
  • Monica Andrade Lima Gabbay,
  • Sérgio Atala Dib,
  • Carlos Eduardo Barra Couri,
  • Angelo Maiolino,
  • Carmen Lúcia Kuniyoshi Rebelatto,
  • Débora Regina Daga,
  • Alexandra Cristina Senegaglia,
  • Paulo Roberto Slud Brofman,
  • Leandra S. Baptista,
  • José Egídio Paulo de Oliveira,
  • Lenita Zajdenverg,
  • Melanie Rodacki

DOI
https://doi.org/10.20945/2359-3997000000368
Journal volume & issue
Vol. 65, no. 3
pp. 342 – 351

Abstract

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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.

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