Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus

NACompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 1, 2015

Primary Completion Date

March 1, 2021

Study Completion Date

May 1, 2021

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.

Trial Locations (1)

21941-913

Clementino Fraga Filho University Hospital of Rio de Janeiro, Rio de Janeiro

All Listed Sponsors
lead

Universidade Federal do Rio de Janeiro

OTHER

NCT03920397 - Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus | Biotech Hunter | Biotech Hunter