Status:
COMPLETED
Safety and Efficacy Study of Autologous Stem Cell Transplantation for Early Onset Type I Diabetes Mellitus
Lead Sponsor:
University of Sao Paulo
Collaborating Sponsors:
Northwestern University
Genzyme, a Sanofi Company
Conditions:
Type 1 Diabetes Mellitus
Eligibility:
All Genders
12-35 years
Phase:
PHASE1
PHASE2
Brief Summary
The study evaluates the effect of inactivation of the immune system with chemotherapy and immunotherapy and infusion of bone marrow stem cells in early onset type 1 diabetes mellitus. We hypothesize t...
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. Peripheral bloo...
Eligibility Criteria
Inclusion
- Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibodies
- Less than 12 weeks from diagnosis
Exclusion
- Previous diabetic ketoacidosis
- Pregnancy
- Severe psychiatric disorder
- Severe organic impairment (renal, hepatic, cardiac, pulmonary)
- Active infectious disease
- Previous or present neoplastic disease
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00315133
Start Date
December 1 2003
End Date
December 1 2014
Last Update
January 18 2017
Active Locations (1)
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1
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Ribeirão Preto, Ribeirão Preto, Brazil, 14048-900