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Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus

NCT03920397 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2021-05-26

No results posted yet for this study

Summary

In this prospective, dual-center, open trial, patients with recent onset type 1 diabetes will receive one dose of allogenic Adipose tissue-derived stromal/stem cells (1x106 cells/kg) and oral cholecalciferol 2000UI/day for 24 months (group 1). They will be compare to patients that will receive just oral cholecalciferol 2000UI/day (group 2) and standard treatment (group 3: no treatment). Adverse events will be record. In addition, glycated hemoglobin, insulin dose, frequency of hypoglycemia, glycemic variability, % of time in hyper and hypoglycemia and peak response of the C-peptide after the mixed meal teste wil be measure at baseline (T0), after 3 (T3), 6 (T6), 12 (T12), 18 (T18), and 24 (T24) months.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

BIOLOGICAL

Infusion of adipose tissue-derived stem/stromal cells and oral Cholecalciferol supplementation

The investigators will acess area under the curve of C-peptide after a liquid mixed meal (Glucerna®), considering the time 0 (basal), 30, 60, 90 and 120 minutes in each follow-up outpatient visit (3 \[T3\], 6 \[T6\], 12 \[T12\], 18 \[T18\], and 24 \[T24\] months after the adipose tissue-derived stem/stromal cells infusion). Other Clinical and Pancreatic Function Evaluation that wil be assess are: Weight, height, body mass index (BMI), blood pressure, heart frequency, frequency of hypoglycemia and insulin dose/kg of body weight, blood count, lipids, renal and hepatic function, thyroid stimulating hormone, free tyroxine, antithyroglobulin antibody, calcium, phosphorus and 25-Hydroxy Vitamin D.

Sponsors & Collaborators

  • Universidade Federal do Rio de Janeiro

    lead OTHER

Principal Investigators

  • Melanie Rodacki, Ph.D · Universidade Federal do Rio de Janeiro

  • Oliveira E.P José, Ph.D · Universidade Federal do Rio de Janeiro

  • Lenita Zajdenverg, Ph.D · Universidade Federal do Rio de Janeiro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-01
Primary Completion
2021-03-01
Completion
2021-05-01

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03920397 on ClinicalTrials.gov