Diabetes Mellitus, Insulin-Dependent
Conditions
Keywords
Diabetes mellitus, Stem cells, Autologous stem cell transplantation, Autoimmune diseases
Brief summary
Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing pancreatic β-cells. The autoimmune response begins months or even years before the presentation of hyperglycemic symptoms. Previous studies with other autoimmune diseases or acute inflammatory diseases testing the effect of the infusion of mesenchymal stem cells showed promising results in regulating immune system and promoting some degree of disease control. The aim of our study is to determine the safety and efficacy of intravenous infusions of mesenchymal stem cells in newly diagnosed type 1 diabetic patients.
Detailed description
Patients from 12 to 35 years old with type I diabetes mellitus proved by anti-pancreatic beta cell antibodies and recently diagnosed (less than 6 weeks) will be included in this study. First, bone marrow derived adult mesenchymal stem cells are collected from a first degree relative and cultured. After that, the patient receive 4 intravenous infusions 1 week apart followed by 4 infusion 4 months apart.
Interventions
BIOLOGICALIntravenous Mesenchymal stem cell infusion
Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart
Sponsors
University of Sao Paulo
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibodies * Less than 6 weeks from diagnosis
Exclusion criteria
* Previous diabetic ketoacidosis * Pregnancy * Severe psychiatric disorder * Severe organic impairment (renal, hepatic, cardiac, pulmonary) * Active infectious disease * Previous or present neoplastic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC C-peptide levels during mixed meal tolerance test | pré-treatment, 6 months, 12 months and then yearly (course of study 7 years) | — |
| Safety | Every 6 months until death | The process of analyzing safety data is made daily based on clinical interview, frequent physical examination and general laboratory findings weekly from the first stem cell infusion until 60 months after the last infusion. Chest X-ray will be performed in days 100, 180, 270, 360 after the lest infusion and then every 6 months. Fecal occult blood, alpha pheto protein, beta-human chorionic gonadotropin, carcino-embrionary antigen, abdomen ultrasound will be performed in month 6 and 12 after the last infusion and then yearly. |
Secondary
| Measure | Time frame |
|---|---|
| Daily insulin use | Daily (course of study is 7 years) |
| Hemoglobin A1C | 3 months |
| Anti-GAD titres | Every 6 months |
| Immunologic reconstitution parameters | Yearly (course of study is 7 years) |
Countries
Brazil
Contacts
Primary ContactJulio Voltarelli, MD, PhD
Backup ContactCarlos E Couri
Outcome results
None listed