Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus

NCT03920397 | Completed DMC

• 1 other identifier: Nutro_MesenchymalStemCells_DM1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

type 1 diabetes; pancreatic function; adipose tissue-derived stromal/stem cells

Outcome Measures

Primary Outcomes (2)

• Pancreatic β-cell function after an adipose tissue-derived stem/stromal cells infusion

  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)

  24 months

• Glycemic control after an adipose tissue-derived stem/stromal cells

  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)

  24 months

Secondary Outcomes (1)

• Oral cholecalciferol 2000UI/day supplementation

  24 months

Study Arms (2)

Adipose tissue-derived stem/stromal cells

EXPERIMENTAL

Safety of adipose tissue-derived stem/stromal cells (ASCs) for 24 months in patients with recente onset type 1 diabetes.

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

Daily 2000 UI of daily oral cholecalciferol

EXPERIMENTAL

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

Interventions

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

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.

Adipose tissue-derived stem/stromal cells; Daily 2000 UI of daily oral cholecalciferol

Eligibility Criteria

• Age: 16 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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 \[anti-IA2\]).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Clementino Fraga Filho University Hospital of Rio de Janeiro

Rio de Janeiro, 21941-913, Brazil

Location

Related Publications (2)

• Dantas JR, Araujo DB, Silva KR, Souto DL, de Fatima 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. Adipose tissue-derived stromal/stem cells + cholecalciferol: a pilot study in recent-onset type 1 diabetes patients. Arch Endocrinol Metab. 2021 Nov 3;65(3):342-351. doi: 10.20945/2359-3997000000368. Epub 2021 Apr 29.

  PMID: 33939911 RESULT

• Araujo DB, Dantas JR, Silva KR, Souto DL, Pereira MFC, Moreira JP, Luiz RR, Claudio-Da-Silva CS, Gabbay MAL, Dib SA, Couri CEB, Maiolino A, Rebelatto CLK, Daga DR, Senegaglia AC, Brofman PRS, Baptista LS, Oliveira JEP, Zajdenverg L, Rodacki M. Allogenic Adipose Tissue-Derived Stromal/Stem Cells and Vitamin D Supplementation in Patients With Recent-Onset Type 1 Diabetes Mellitus: A 3-Month Follow-Up Pilot Study. Front Immunol. 2020 Jun 2;11:993. doi: 10.3389/fimmu.2020.00993. eCollection 2020.

  PMID: 32582156 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Melanie Rodacki, Ph.D

  Universidade Federal do Rio de Janeiro

  PRINCIPAL INVESTIGATOR

• Oliveira E.P José, Ph.D

  Universidade Federal do Rio de Janeiro

  STUDY DIRECTOR

• Lenita Zajdenverg, Ph.D

  Universidade Federal do Rio de Janeiro

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is a open trial study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph. D. in Nutrition Sciences

Model Details: 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.

Study Record Dates

• First Submitted: April 5, 2019
• First Posted: April 18, 2019
• Study Start: March 1, 2015
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)