Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dra. Olga Graciela Cantu Rodriguez, Hospital Universitario Dr. Jose E. Gonzalez
ClinicalTrials.gov Identifier:
NCT01121029
First received: May 11, 2010
Last updated: December 6, 2012
Last verified: December 2012

May 11, 2010
December 6, 2012
May 2010
December 2011   (final data collection date for primary outcome measure)
C-peptide levels before and after the hematopoietic stem cell transplantation [ Time Frame: Every 3 months for 1 year. ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01121029 on ClinicalTrials.gov Archive Site
Serum levels of Hb A1C before and after the hematopoietic stem cell transplantation [ Time Frame: Every month for 1 year. ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus
Autologous Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

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.

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.

Interventional
Phase 1
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
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
Experimental: Hematopoietic stem cells
Intervention: Procedure: Autologous hematopoietic stem cell transplantation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
2 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
NCT01121029
EN10-011
Yes
Dra. Olga Graciela Cantu Rodriguez, Hospital Universitario Dr. Jose E. Gonzalez
Dra. Olga Graciela Cantu Rodriguez
Not Provided
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
Hospital Universitario Dr. Jose E. Gonzalez
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP