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Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

NCT01121029 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2012-12-10

No results posted yet for this study

Summary

The purpose of this study is to determine if autologous nonmyeloablative hematopoietic stem cell transplantation is able to induce prolonged and significant increases of C-peptide levels associated with absence of or reduction of daily insulin.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

PROCEDURE

Autologous hematopoietic stem cell transplantation

Patients will receive a stimulation with filgrastim 10mcg/Kg per day during 4 days and cyclophosphamide 1.5g/m2 per day during 2 days and mesna 300mg/m2 i.v. in 4 hours for prophylaxis (uroprotection). Lately, the stem cells will be recollected by apheresis. After that, the patients will receive a conditioning regimen with cyclophosphamide 500mg/m2 per day during 4 days and fludarabine 30mg/m2 per day during 4 days. After the last dose of cyclophosphamide, the autologous hematopoietic stem cell transplantation will be done on day 0, by peripheral vein. Then, a standard regimen of prophylaxis with oral ciprofloxacin 500mg every 12 hours, acyclovir 400mg every 8 hours, fluconazole 100mg per day and omeprazole 20mg per day for the recovery time of each patient.

Sponsors & Collaborators

  • Dra. Olga Graciela Cantu Rodriguez

    lead OTHER

Principal Investigators

  • Fernando J Lavalle, MD · Hospital Universitario Dr. José Eleuterio González

  • David Gómez, MD · Hospital Universitario Dr. José Eleuterio González

  • Olga G Cantú, MD · Hospital Universitario Dr. José Eleuterio González

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2011-12-31
Completion
2012-12-31

Countries

  • Mexico

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 NCT01121029 on ClinicalTrials.gov