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Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT01121029
Recruitment Status : Completed
First Posted : May 12, 2010
Last Update Posted : December 10, 2012
Sponsor:
Information provided by (Responsible Party):
Dra. Olga Graciela Cantu Rodriguez, Hospital Universitario Dr. Jose E. Gonzalez

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Procedure: Autologous hematopoietic stem cell transplantation Phase 1 Phase 2

Detailed Description:

Patients with type 1 DM depend on exogenous insulin administration for survival and for control of long-term complications. The best-established treatment is tight control of blood glucose achieved by frequent daily injections or continuous subcutaneous infusion of insulin, ie, intensive insulin therapy. Although insulin therapy has developed enormously, even the most modern technologies do not allow the maintenance of normoglycemia.

Since the establishment of the autoimmune etiology of type 1 DM in the late 1970s, many clinical trials analyzing the effects of different types of immune interventions demonstrated that beta-cell preservation is an achievable target in different degrees.

Controlled trials and further biological studies are necessary to confirm the role of this treatment in changing the natural history of type 1 DM.

This is a prospective pilot study which will enroll patients with type 1 diabetes mellitus within the first months of diagnosis, with clinical and laboratory findings. The donor stimulation will be with cyclophosphamide, filgrastim, and mesna. The cells will be recollected from peripheral blood by apheresis and refrigerated. The patients will receive a nonmyeloablative conditioning regimen with cyclophosphamide and fludarabine, and after this, the cells will be injected intravenously. They will receive a standard regimen of post-transplant prophylaxis. The duration of use of this prophylactic drugs scheme depends on the patient's recovery time. The reinfusion of stem cells will be completed after the last dose of cyclophosphamide, through a peripheral vein.

Lately, every three months, the C-Peptide levels, glucose and insulin serum levels will be measured.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus
Study Start Date : May 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Hematopoietic stem cells 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.
Other Name: Stem cell therapy


Outcome Measures
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Primary Outcome Measures :
  1. C-peptide levels before and after the hematopoietic stem cell transplantation [ Time Frame: Every 3 months for 1 year. ]

Secondary Outcome Measures :
  1. Serum levels of Hb A1C before and after the hematopoietic stem cell transplantation [ Time Frame: Every month for 1 year. ]

Eligibility Criteria
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Ages Eligible for Study:   2 Years to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed in type 1 diabetes mellitus

Exclusion Criteria:

  • Patients with HIV
  • Patients with Hepatitis
  • Patients with hematologic disease
  • Patients with hearth failure
  • Renal, Hepatic or psychiatric disease
  • Pregnant patients
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121029


Locations
Mexico
Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo Leon, Mexico, 64460
Sponsors and Collaborators
Dra. Olga Graciela Cantu Rodriguez
Investigators
Principal Investigator: Fernando J Lavalle, MD Hospital Universitario Dr. José Eleuterio González
Study Chair: David Gómez, MD Hospital Universitario Dr. José Eleuterio González
Study Director: Olga G Cantú, MD Hospital Universitario Dr. José Eleuterio González
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Dra. Olga Graciela Cantu Rodriguez, Autologous Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier: NCT01121029     History of Changes
Other Study ID Numbers: EN10-011
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: December 10, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases