Departamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil.
Laboratório de Bioengenharia de Tecidos, Instituto Nacional de Metrologia, Qualidade e Tecnologia (Inmetro), Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.
Arch Endocrinol Metab. 2021 Nov 3;65(3):342-351. doi: 10.20945/2359-3997000000368. Epub 2021 Apr 29.
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.
In this prospective, dual-center, open trial, patients with recent onset T1D received one dose of allogenic ASC (1 × 10 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).
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.
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.
脂肪组织来源的基质/干细胞（ASCs）和维生素 D 具有免疫调节作用，可用于 1 型糖尿病（T1D）。本研究旨在探讨近期诊断的 T1D 患者接受 ASC 联合每日胆钙化醇（VIT D）治疗 6 个月的安全性和有效性。
在这项前瞻性、双中心、开放试验中，近期诊断的 T1D 患者接受 1 剂同种异体 ASC（1×10 个细胞/kg）和胆钙化醇 2000 UI/天，持续 6 个月（第 1 组）。将其与接受胆钙化醇（第 2 组）和标准治疗（第 3 组）的患者进行比较。记录不良事件；在基线（T0）、3 个月（T3）和 6 个月（T6）时测量 C 肽（CP）、胰岛素剂量和 HbA1c。
第 1 组（n=7）的不良事件包括短暂头痛（所有患者）、轻度局部反应（所有患者）、心动过速（n=4）、腹痛（n=1）、血栓性静脉炎（n=4）、视野缺损（n=2）和 T3 时中央视网膜静脉阻塞（n=1，T6 时恢复）。第 1 组基础 CP 增加（p=0.018；平均：40.41±40.79%），混合餐刺激后 CP 无变化（p=0.62），从 T0 到 T6。第 2 组和第 3 组基础 CP 保持稳定（p=0.58 和 p=0.116）。第 1 组胰岛素需求小（0.31±0.26 UI/kg），T6 时无变化（p=0.44），HbA1c 下降（p=0.01）。T6 时，第 1 组所有患者（100%；n=7）均处于蜜月期，而第 2 组和第 3 组分别有 75%（n=3/4）和 50%（n=3/6）的患者处于蜜月期，p=0.01。
未进行免疫抑制的同种异体 ASC+VIT D 是安全的，可能在保护近期诊断的 T1D 患者的β细胞方面发挥作用。ClinicalTrials.gov：NCT03920397。
