NCT00315133View on ClinicalTrials.gov

Safety and Efficacy Study of Autologous Stem Cell Transplantation for Early Onset Type I Diabetes Mellitus

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

25

Participants

Timeline

Start Date

December 31, 2003

Primary Completion Date

December 31, 2010

Study Completion Date

December 31, 2014

Conditions
Type 1 Diabetes Mellitus
Interventions
PROCEDURE

Immunosuppression and autologous stem cell transplantation

Immunosuppression and autologous stem cell transplantation: Mobilization of hematopoietic stem cells (HSC) with cyclophosphamide (2 g/m2) and granulocyte-colony stimulating factor (G-CSF, 10 ug/kg/d), followed by collection and cryopreservation of unselected HSC and conditioning with cyclophosphamide (200 mg/kg) plus rabbit anti-thymocyte globulin (ATG 4.5 mg/kg).

Trial Locations (1)

14048-900

Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Ribeirão Preto

All Listed Sponsors
collaborator

Northwestern University

OTHER

collaborator

Genzyme, a Sanofi Company

INDUSTRY

lead

University of Sao Paulo

OTHER

NCT00315133 - Safety and Efficacy Study of Autologous Stem Cell Transplantation for Early Onset Type I Diabetes Mellitus | Biotech Hunter | Biotech Hunter