Safety and Efficacy Study of Autologous Stem Cell Transplantation for Early Onset Type I Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT00315133|
Recruitment Status : Completed
First Posted : April 17, 2006
Last Update Posted : January 18, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes Mellitus||Procedure: Immunosuppression and autologous stem cell transplantation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Autologous Hematopoietic Stem Cell Transplantation for Early Onset Type 1 Diabetes Mellitus- a Phase I/II Study|
|Study Start Date :||December 2003|
|Primary Completion Date :||December 2010|
|Study Completion Date :||December 2014|
Experimental: Transplant arm
This is a single arm study. The intervention is immunosuppression and autologous stem cell transplantation.
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).
- C-peptide levels [ Time Frame: Every 6 months ]Stimulated C-peptide levels will be measured.
- Transplant-related toxicity [ Time Frame: Every 6 months or when reported ]
- Anti-GAD titres [ Time Frame: Every 6 months ]
- Exogenous insulin dose [ Time Frame: Every 6 months ]Number of international insulin units per kilogram per day in use will be registered.
- Hemoglobin A1C [ Time Frame: Every 6 months ]Hb A1C will be measured.
- Immunologic reconstitution parameters [ Time Frame: Yearly ]
- Quality of Life [ Time Frame: Every year ]SF-36 questionnaire
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00315133
|Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo|
|Ribeirão Preto, Brazil, 14048-900|
|Principal Investigator:||Julio C Voltarelli, MD PhD||University Hospital, School of Medicine of Ribeirão Preto, Brazil|
|Study Chair:||Maria C Oliveira, MD PhD||University Hospital, Ribeirão Preto Medical School, Brazil|