ABSTRACT
Objective: 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 (1 × 106 cells/kg) and cholecalciferol 2000 UI/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.
Subject(s)
Adipose Tissue/cytology , Cholecalciferol/therapeutic use , Diabetes Mellitus, Type 1/therapy , Dietary Supplements , Mesenchymal Stem Cell Transplantation , Vitamins/therapeutic use , Adolescent , Adult , Biomarkers/blood , Blood Glucose/metabolism , Brazil , Cholecalciferol/adverse effects , Combined Modality Therapy , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/diagnosis , Dietary Supplements/adverse effects , Female , Glycated Hemoglobin/metabolism , Humans , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Male , Mesenchymal Stem Cell Transplantation/adverse effects , Pilot Projects , Prospective Studies , Time Factors , Transplantation, Homologous , Treatment Outcome , Vitamins/adverse effects , Young AdultABSTRACT
C peptide (CP) was evaluated in 88 individuals with type 1 diabetes, variable disease duration and multiethnic background. Initially, 28 patients had detectable CP, which persisted in 46.2% after 17.4±4 months. CP decline was associated with ethnicity, HbA1c and baseline CP, but not with GADA, PTPN22 or insulin gene polymorphisms.
Subject(s)
C-Peptide/metabolism , Diabetes Mellitus, Type 1/ethnology , Diabetes Mellitus, Type 1/metabolism , Adolescent , Adult , Age of Onset , Black People , Child , Female , Glycated Hemoglobin/metabolism , Humans , Insulin/genetics , Male , White PeopleABSTRACT
A administraçäo de insulina geralmente é realizada com seringa e agulha. Porém, a injeçäo é frequantemente considerada dolorosa e traumática, causando problemas psicossociais em muitos pacientes com diabetes. Reconhece-se que as canetas de injeçäo de insulina säo mais convenientes, causam menos dor à injeçäo e melhoram a qualidade de vida dos pacientes. Este estudo examinou a aceitabilidade funcionalidade de uma nova caneta de administraçäo de insulina reutilizável, Humapen, em 94 pacientes diabéticos tipo 1 e 2 os quais usavam insulina por um tempo mediano de 7,8 anos com 2,7 +/- 3,0 aplicaçöes por dia. Quarenta e dois por cento deles usava outras canetas, e os 58 por cento restantes usava seringas. Os pacietes fizeram uso de Humapen por 8 semanas, mantendo o esquema de insulinizaçäo prévio. Todos os pacientes completaram o estudo...
