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 citations
How it was studied
- Design
- Randomized controlled trial (indexed by PubMed)
- Studied in
- People
- Main outcome
- Health markers and function
Who paid for it
- Funding
- Independent funding
- Government
- Coordenação de Aperfeiçoamento de Pessoal de Nível Superior
- Government
- Fundação Carlos Chagas Filho de Amparo à Pesquisa do Estado do Rio de Janeiro
- Government
- National Institute of Metrology, China
Based on 3 listed funder(s).
Publication
- Published
- 2021-04-29 · Arch Endocrinol Metab · vol. 65 · issue 3 · pp. 342–351
- Publisher
- Brazilian Society of Endocrinology and Metabolism
- Cited
- 32 citations · more than 91% of similar papers · 2.6× the field average
- Impact
- Top 10% most cited in its field
- References
- 31 works
- Access
- Open access (free to publish) · CC-BY
- Research areas
- Mesenchymal stem cell research · Pancreatic function and diabetes · Vitamin D Research Studies
- Keywords
- 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 authors
From BR
- Joana Rodrigues DantasUniversidade Federal do Rio de Janeiro
- Débora Batista AraújoUniversidade Federal do Rio de Janeiro
- Karina Ribeiro SilvaUniversidade Federal do Rio de Janeiro; Instituto Nacional de Metrologia, Qualidade e Tecnologia
- Débora Lopes SoutoUniversidade Federal do Rio de Janeiro
- Maria de Fátima Carvalho PereiraUniversidade Federal do Rio de Janeiro
- Ronir Raggio LuizUniversidade Federal do Rio de Janeiro
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.
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.
Abstract via Europe PMC. Copyright remains with the authors or publisher (CC BY).
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