Evidence map›Paper›PMID 33939911›Full record

Trial reportArchives of endocrinology and metabolism2021

Adipose tissue-derived stromal/stem cells + cholecalciferol: a pilot study in recent-onset type 1 diabetes patients.

Joana Rodrigues Dantas, Débora Batista Araújo, Karina Ribeiro Silva, Débora Lopes Souto, Maria de Fátima Carvalho Pereira, Ronir Raggio Luiz, Matheus Dos Santos Mantuano, Cesar Claudio-da-Silva, Monica Andrade Lima Gabbay, Sérgio Atala Dib and 10 more

Registry-linked trialOpen access · diamondAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Archives of endocrinology and metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03920397 (Allogenic Adipose Derived Mesenchymal Stem Cells and Vitamin D Supplementation in Patients With Recent-onset Type 1 Diabetes Mellitus), which is not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed, 2 pooled it
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03920397 nacompletednot on this map

Allogenic Adipose Derived Mesenchymal Stem Cells and Vitamin D Supplementation in Patients With Recent-onset Type 1 Diabetes Mellitus

TypeinterventionalSponsorUniversidade Federal do Rio de JaneiroRan2015 to 2021Enrolled30ConditionsType 1 Diabetes MellitusArmsInfusion of adipose tissue-derived stem/stromal cells and oral Cholecalciferol supplementation
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 31 citations in OpenAlex.

  1. Pooled it
  2. Vitamin D and Beta Cells in Type 1 Diabetes: A Systematic Review.International journal of molecular sciences · 2022
    Pooled it
  3. Trial
  4. Review
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  7. Review
  8. Review
  9. Review
  10. Review
  11. Article
  12. Review
  13. Review
  14. Review
  15. Stem Cell Therapy for the Management of Type 1 Diabetes: Advances and Perspectives.Endocrine, metabolic & immune disorders drug targets · 2024
    Review
  16. Review
  17. Review
  18. Review
  19. Stem cell-based therapy for human diseases.Signal transduction and targeted therapy · 2022
    Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors at 4 institutions in 1 country.

Joana Rodrigues DantasDepartamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil.
Débora Batista AraújoDepartamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil.
Karina Ribeiro SilvaLaboratório de Bioengenharia de Tecidos, Instituto Nacional de Metrologia, Qualidade e Tecnologia (Inmetro), Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.
Débora Lopes SoutoDepartamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil, deboralopessouto@gmail.com.
Maria de Fátima Carvalho PereiraServiço de Patologia Clínica, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.
Ronir Raggio LuizInstituto de Estudos de Saúde Pública, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.
Matheus Dos Santos MantuanoFaculdade de Medicina, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.
Cesar Claudio-da-SilvaDepartamento de Cirurgia Plástica, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.
Monica Andrade Lima GabbayUniversidade Federal de São Paulo, São Paulo, SP, Brasil.
Sérgio Atala DibUniversidade de São Paulo, São Paulo, SP, Brasil.
Carlos Eduardo Barra CouriDepartamento de Hematologia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.
Angelo MaiolinoDepartamento de Hematologia, Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil.
Carmen Lúcia Kuniyoshi RebelattoCore Cell Technology, Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brasil.
Débora Regina DagaCore Cell Technology, Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brasil.
Alexandra Cristina SenegagliaCore Cell Technology, Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brasil.
Paulo Roberto Slud BrofmanCore Cell Technology, Pontifícia Universidade Católica do Paraná, Curitiba, PR, Brasil.
Leandra S BaptistaCentro Multidisciplinar de Pesquisas Biológicas (Numpex-Bio), Universidade Federal do Rio de Janeiro, Rio de Janeiro, RJ, Brasil; Laboratório de Bioengenharia de Tecidos, Instituto Nacional de Metrologia, Qualidade e Tecnologia (Inmetro), Rio de Janeiro, RJ, Brasil.
José Egídio Paulo de OliveiraDepartamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil.
Lenita ZajdenvergDepartamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil.
Melanie RodackiDepartamento de Nutrologia e Diabetes, Universidade Federal do Rio de Janeiro, RJ, Brasil.
Universidade Federal do Rio de Janeiro · BRPontifícia Universidade Católica do Paraná · BRUniversidade de São Paulo · BRUniversidade Federal de São Paulo · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveAdipose 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.

methodsIn this prospective, dual-center, open trial, patients with recent onset T1D received one dose of allogenic ASC (1 × 10

resultsIn 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.

conclusionAllogenic 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.

Indexed as

Diabetes Mellitus, Type 1Mesenchymal Stem Cell TransplantationAdipose TissueCholecalciferolHumansPilot ProjectsProspective StudiesStem CellsCholecalciferoladipose tissue-derived stromal/stem cellspancreatic functionType 1 diabetes

Identifiers

PMID33939911
PMCPMC10065343
OpenAlexW3158349243

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.