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
| العنوان: | 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 |
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| المؤلفون: | Debora B. Araujo, Joana R. Dantas, Karina R. Silva, Débora L. Souto, Maria de Fátima C. Pereira, Jessica P. Moreira, Ronir R. Luiz, Cesar S. Claudio-Da-Silva, Monica A. L. Gabbay, Sergio A. Dib, Carlos E. B. Couri, Angelo Maiolino, Carmen L. K. Rebelatto, Debora R. Daga, Alexandra C. Senegaglia, Paulo R. S. Brofman, Leandra Santos Baptista, José E. P. Oliveira, Lenita Zajdenverg, Melanie Rodacki |
| المصدر: | Frontiers in Immunology, Vol 11 (2020) Frontiers in Immunology |
| بيانات النشر: | Frontiers Media S.A., 2020. |
| سنة النشر: | 2020 |
| مصطلحات موضوعية: | Blood Glucose, Male, 0301 basic medicine, Time Factors, type 1 diabetes, medicine.medical_treatment, Adipose tissue, Pilot Projects, vitamin D, Gastroenterology, chemistry.chemical_compound, 0302 clinical medicine, Central retinal vein occlusion, Insulin, Immunology and Allergy, Medicine, Prospective Studies, Cholecalciferol, Vitamins, pancreatic function, Clinical Trial, Combined Modality Therapy, Treatment Outcome, Adipose Tissue, Female, Brazil, Adult, lcsh:Immunologic diseases. Allergy, medicine.medical_specialty, Adolescent, Immunology, Mesenchymal Stem Cell Transplantation, Young Adult, 03 medical and health sciences, Internal medicine, Vitamin D and neurology, Humans, Hypoglycemic Agents, Transplantation, Homologous, transplant, Adverse effect, Glycated Hemoglobin, Type 1 diabetes, business.industry, Therapeutic effect, medicine.disease, Diabetes Mellitus, Type 1, 030104 developmental biology, chemistry, Dietary Supplements, adipose tissue-derived stromal/stem cells, business, lcsh:RC581-607, Biomarkers, 030215 immunology |
| الوصف: | 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. |
| اللغة: | English |
| تدمد: | 1664-3224 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::ac79c87a7ff77f6d009d28bae8c8d1a2Test https://www.frontiersin.org/article/10.3389/fimmu.2020.00993/fullTest |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....ac79c87a7ff77f6d009d28bae8c8d1a2 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 16643224 |
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