Trial record 1 of 1 for:    NCT01121029
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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
  Purpose

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 Intervention Phase
Type 1 Diabetes Mellitus
Procedure: Autologous hematopoietic stem cell transplantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Hospital Universitario Dr. Jose E. Gonzalez:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 15
Study Start Date: May 2010
Study Completion Date: December 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   2 Years to 35 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Otonkoski T, Gao R, Lundin K. Stem cells in the treatment of diabetes. Ann Med. 2005;37(7):513-20.

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
Study First Received: May 11, 2010
Last Updated: December 6, 2012
Health Authority: Mexico: Ethics Committee

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

ClinicalTrials.gov processed this record on August 27, 2014