Adipose tissue-derived stromal/stem cells + cholecalciferol: a pilot study in recent-onset type 1 diabetes patients
Dantas JR, Araújo DB, Silva KR, Souto DL, de Fátima Carvalho Pereira M, Luiz RR, Dos Santos Mantuano M, Claudio-da-Silva C, Gabbay MAL, Dib SA, Couri CEB, Maiolino A, Rebelatto CLK, Daga DR, Senegaglia AC, Brofman PRS, Baptista LS, de Oliveira JEP, Zajdenverg L, Rodacki M
Archives of endocrinology and metabolism · 27 citas
Cómo se estudió
- Diseño
- Ensayo controlado aleatorizado (indexado por PubMed)
- Estudiado en
- Personas
- Resultado principal
- Marcadores de salud y funcionamiento
Quién lo pagó
- Financiación
- Financiación independiente
- Gobierno
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
- Gobierno
- Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro
- Gobierno
- National Institute of Metrology, China
Según 3 financiadores declarados.
Publicación
- Publicado
- 2021-04-29 · Arch Endocrinol Metab · vol. 65 · número 3 · págs. 342–351
- Editorial
- Brazilian Society of Endocrinology and Metabolism
- Citado
- 32 citas · más que el 91% de estudios similares · 2.6× el promedio de su campo
- Impacto
- Entre el 10 % más citado de su campo
- Referencias
- 31 trabajos
- Acceso
- Acceso abierto (publicación gratuita) · CC-BY
- Áreas de investigación
- Mesenchymal stem cell research · Pancreatic function and diabetes · Vitamin D Research Studies
- Palabras clave
- Medicine, Cholecalciferol, Vitamin D and neurology, Adverse effect, Adipose tissue, Internal medicine, Gastroenterology, Insulin, Diabetes mellitus, Type 2 diabetes, Type 1 diabetes, Endocrinology, Surgery
- MeSH
- adipose tissue, stem cells, humans, diabetes mellitus, type 1, cholecalciferol, mesenchymal stem cell transplantation, prospective studies, pilot projects
20 autores
- Joana Rodrigues Dantas🇧🇷Universidade Federal do Rio de Janeiro
- Débora Batista Araújo🇧🇷Universidade Federal do Rio de Janeiro
- Karina Ribeiro Silva🇧🇷Universidade Federal do Rio de Janeiro; Instituto Nacional de Metrologia, Qualidade e Tecnologia
- Débora Lopes Souto🇧🇷Universidade Federal do Rio de Janeiro
- Maria de Fátima Carvalho Pereira🇧🇷Universidade Federal do Rio de Janeiro
- Ronir Raggio Luiz🇧🇷Universidade Federal do Rio de Janeiro
- M. Mantuano🇧🇷Universidade Federal do Rio de Janeiro
- Cesar Silveira Cláudio-da-Silva🇧🇷Universidade Federal do Rio de Janeiro; Universidade Federal do Estado do Rio de Janeiro
- Mônica Andrade Lima Gabbay🇧🇷Universidade Federal de São Paulo
- Sérgio Atala Dib🇧🇷Universidade de São Paulo
- Carlos Eduardo Barra Couri🇧🇷Universidade Federal do Rio de Janeiro
- Ângelo Maiolino🇧🇷Universidade Federal do Rio de Janeiro
- Cármen Lúcia Kuniyoshi Rebelatto🇧🇷Pontifícia Universidade Católica do Paraná
- Débora Regina Daga🇧🇷Pontifícia Universidade Católica do Paraná
- Alexandra Cristina Senegaglia🇧🇷Pontifícia Universidade Católica do Paraná
- Paulo Roberto Slud Brofman🇧🇷Pontifícia Universidade Católica do Paraná
- Leandra Santos Baptista🇧🇷Universidade Federal do Rio de Janeiro; Instituto Nacional de Metrologia, Qualidade e Tecnologia
- José Egídio Paulo de Oliveira🇧🇷Universidade Federal do Rio de Janeiro
- Lenita Zajdenverg🇧🇷Universidade Federal do Rio de Janeiro
- Melanie Rodacki🇧🇷Universidade Federal do Rio de Janeiro
Resumen
El texto original del estudio, en el idioma en que se publicó.
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.
Methods
In this prospective, dual-center, open trial, patients with recent onset T1D received one dose of allogenic ASC (1 × 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.
Conclusion
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.
Resumen vía Europe PMC. Los derechos de autor siguen siendo de los autores o la editorial (CC BY).
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