NCT01322789

Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: University of Sao Paulo · Academic / Other
• Sex: All
• Age: 12 Years – 35 Years
• Healthy volunteers: Accepted

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.

Conditions

• Diabetes Mellitus, Insulin-Dependent

Interventions

Type	Name	Description
BIOLOGICAL	Intravenous Mesenchymal stem cell infusion	Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart

Timeline

• Start date: 2008-09-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2011-03-25
• Last updated: 2011-03-25

Locations

1 site across 1 country: Brazil