Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Procedure: Autologous hematopoietic stem cell transplantation

• Registration Number: NCT01121029
• Lead Sponsor: Dra. Olga Graciela Cantu Rodriguez

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.

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 Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-05-11
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-12
• Primary Completion: 2011-12
• Status Verified: 2012-12
• Study Completion: 2012-12
• Last Update Submitted: 2012-12-06
• Last Update Posted: 2012-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hematopoietic stem cells	Autologous hematopoietic stem cell transplantation	-

Primary Outcome Measures

Name	Time	Method
C-peptide levels before and after the hematopoietic stem cell transplantation	Every 3 months for 1 year.

Secondary Outcome Measures

Name	Time	Method
Serum levels of Hb A1C before and after the hematopoietic stem cell transplantation	Every month for 1 year.

Trial Locations

Locations (1)

Hospital Universitario Dr. José Eleuterio González; 🇲🇽 Monterrey, Nuevo Leon, Mexico