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

University of Sao Paulo

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Diabetes Mellitus, Insulin-Dependent

Treatments: Biological: Intravenous Mesenchymal stem cell infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01322789

CNPQ 552266/2005-1 (Other Grant/Funding Number)

HCFMRPUSP 2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 12 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Intravenous mesenchymal stem cell

Experimental group

Description:

This group wil receive 8 intravenous infusions of mesenchymal stem cells. Four infusions 1 week apart and 4 infusions a month apart

Treatment:

Biological: Intravenous Mesenchymal stem cell infusion