Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus
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ClinicalTrials.gov Identifier: NCT03920397 |
Recruitment Status :
Enrolling by invitation
First Posted : April 18, 2019
Last Update Posted : March 30, 2020
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Condition or disease | Intervention/treatment | Phase |
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Type 1 Diabetes Mellitus | Biological: Infusion of adipose tissue-derived stem/stromal cells and oral Cholecalciferol supplementation | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Patients with recent onset type 1 diabetes wil receive an dose of allogenic adipose tissue-derived stem/stromal cells (ASCs) and oral Cholecalciferol UI/day for 24 months. |
Masking: | None (Open Label) |
Masking Description: | This is a open trial study. |
Primary Purpose: | Treatment |
Official Title: | Allogenic Adipose Derived Mesenchymal Stem Cells and Vitamin D Supplementation in Patients With Recent-onset Type 1 Diabetes Mellitus |
Actual Study Start Date : | March 1, 2015 |
Actual Primary Completion Date : | March 1, 2020 |
Estimated Study Completion Date : | December 1, 2025 |

Arm | Intervention/treatment |
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Experimental: Adipose tissue-derived stem/stromal cells
Safety of adipose tissue-derived stem/stromal cells (ASCs) for 24 months in patients with recente onset type 1 diabetes.
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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. |
Experimental: Daily 2000 UI of daily oral cholecalciferol
To investigate the efficacy of daily 2000 UI Cholecalciferol/day for 24 months in patients with recente onset type 1 diabetes.
|
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. |
- Pancreatic β-cell function after an adipose tissue-derived stem/stromal cells infusion [ Time Frame: 24 months ]
Thirth patients with recent-onset type 1 diabetes wil receive adipose tissue-derived stem/stromal cells (ASCs). The patients wil be admitte in the day of the infusion and wil discharge 24 hours after infusion. A single dose of ASCs wil be infuse in a peripheral upper arm vein during 15-20 minutes.
Pancreatic β-cell function will be assess at each follow-up outpatient visit (1, 3, 6, 12, 18 and 24 months after the ASCs infusion). In each visit, C-Peptide wil be analyze by immunofluorometric assay, considering the time 0 (basal), and peak stimulated C-Peptide (30, 60, 90 and 120 minutes) after mixed meal test (Glucerna)
- Glycemic control after an adipose tissue-derived stem/stromal cells [ Time Frame: 24 months ]
Thirth patients with recent-onset type 1 diabetes wil receive adipose tissue-derived stem/stromal cells (ASCs). The patients wil be admitte in the day of the infusion and wil discharge 24 hours after infusion. A single dose of ASCs wil be infuse in a peripheral upper arm vein during 15-20 minutes.
Frequency of hypoglycemia (%) insulin dose/kg, and blood samples will be drawn for the Glycated hemoglobin assessment (High Performance Liquid Chromatography by boronate affinity) at each follow-up outpatient visit (1, 3, 6, 12, 18 and 24 months after the ASCs infusion)
- Oral cholecalciferol 2000UI/day supplementation [ Time Frame: 24 months ]
The same patients with recent-onset type 1 diabetes wil receive adipose tissue-derived stem/stromal cells (ASCs) will receive Oral cholecalciferol 2000UI/day supplementation for 24 months.
The sérum 25-Hydroxy Vitamin D will be assess at each follow-up outpatient visit (1, 3, 6, 12, 18 and 24 months after the ASCs infusion) and C-Peptide wil be analyze by immunofluorometric assay, considering the time 0 (basal), and peak stimulated C-Peptide (30, 60, 90 and 120 minutes) after mixed meal test (Glucerna)

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Ages Eligible for Study: | 16 Years to 35 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of Type 1 Diabetes according to the American Diabetes Association criteria for a period less than four months.
- Pancreatic Autoimmunity (positive anti-glutamic acid decarboxylase [GAD]; and/or Islet antigen 2 [anti-IA2]).
Exclusion Criteria:
- Clinical evidence of malignancy or prior history.
- Pregnancy or desire to become pregnant within 12 months of the study.
- Breastfeeding .
- HIV(+), Hepatitis B (+), Hepatitis C(+).
- Diabetic ketoacidosis at diagnosis.
- Glomerular filtration rate less than 60ml/min.
- Use of immunosuppressors or glucocorticoids.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920397
Brazil | |
Clementino Fraga Filho University Hospital of Rio de Janeiro | |
Rio de Janeiro, Brazil, 21941-913 |
Principal Investigator: | Melanie Rodacki, Ph.D | Universidade Federal do Rio de Janeiro | |
Study Director: | Oliveira E.P José, Ph.D | Universidade Federal do Rio de Janeiro | |
Study Director: | Lenita Zajdenverg, Ph.D | Universidade Federal do Rio de Janeiro |
Responsible Party: | Débora Lopes Souto, Ph. D. in Nutrition Sciences, Universidade Federal do Rio de Janeiro |
ClinicalTrials.gov Identifier: | NCT03920397 |
Other Study ID Numbers: |
Nutro_MesenchymalStemCells_DM1 |
First Posted: | April 18, 2019 Key Record Dates |
Last Update Posted: | March 30, 2020 |
Last Verified: | March 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
type 1 diabetes pancreatic function adipose tissue-derived stromal/stem cells |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Autoimmune Diseases Immune System Diseases Cholecalciferol |
Calcium-Regulating Hormones and Agents Physiological Effects of Drugs Vitamins Micronutrients Nutrients Growth Substances Bone Density Conservation Agents |