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

NCT01322789 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2011-03-25

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Insulin-Dependent

Interventions

BIOLOGICAL

Intravenous Mesenchymal stem cell infusion

Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart

Sponsors & Collaborators

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Julio Voltarelli, MD, PhD · University Hospital, School of Medicine of Ribeirão Preto, Brazil

  • Carlos E Couri, MD, PhD · University Hospital, School of Medicine of Ribeirão Preto, Brazil

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-09-30
Primary Completion
2015-11-30
Completion
2015-12-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01322789 on ClinicalTrials.gov