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

NCT00315133 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2017-01-18

No results posted yet for this study

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 that reprograming the immune system will stop immune aggression to the insulin producing cells allowing their regeneration and thus decreasing or eliminating the need of exogenous insulin.

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).

Sponsors & Collaborators

  • Northwestern University

    collaborator OTHER

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • University of Sao Paulo

    lead OTHER

Principal Investigators

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

  • Maria C Oliveira, MD PhD · University Hospital, Ribeirão Preto Medical School, Brazil

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-12-31
Primary Completion
2010-12-31
Completion
2014-12-31

Countries

  • Brazil

Study Locations

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Entities

Companies

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 NCT00315133 on ClinicalTrials.gov