Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

NCT01121029 | Completed Phase 1 DMC

• 1 other identifier: EN10-011
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• C-peptide levels before and after the hematopoietic stem cell transplantation

  Every 3 months for 1 year.

Secondary Outcomes (1)

• Serum levels of Hb A1C before and after the hematopoietic stem cell transplantation

  Every month for 1 year.

Study Arms (1)

Hematopoietic stem cells

EXPERIMENTAL

Procedure: Autologous hematopoietic stem cell transplantation

Interventions

Autologous hematopoietic stem cell transplantation PROCEDURE

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.

Also known as: Stem cell therapy

Hematopoietic stem cells

Eligibility Criteria

• Age: 2 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with newly diagnosed in type 1 diabetes mellitus

You may not qualify if:

• Patients with HIV
• Patients with Hepatitis
• Patients with hematologic disease
• Patients with hearth failure
• Renal, Hepatic or psychiatric disease
• Pregnant patients

Sponsors & Collaborators

• Dra. Olga Graciela Cantu Rodriguez: lead

Study Sites (1)

Hospital Universitario Dr. José Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

Location

Related Publications (8)

• Couri CE, Voltarelli JC. Potential role of stem cell therapy in type 1 diabetes mellitus. Arq Bras Endocrinol Metabol. 2008 Mar;52(2):407-15. doi: 10.1590/s0004-27302008000200029.

  PMID: 18438552 BACKGROUND

• Couri CE, Foss MC, Voltarelli JC. Secondary prevention of type 1 diabetes mellitus: stopping immune destruction and promoting beta-cell regeneration. Braz J Med Biol Res. 2006 Oct;39(10):1271-80. doi: 10.1590/s0100-879x2006001000002. Epub 2006 Aug 22.

  PMID: 16941054 BACKGROUND

• Voltarelli JC, Couri CE, Stracieri AB, Oliveira MC, Moraes DA, Pieroni F, Coutinho M, Malmegrim KC, Foss-Freitas MC, Simoes BP, Foss MC, Squiers E, Burt RK. Autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus. JAMA. 2007 Apr 11;297(14):1568-76. doi: 10.1001/jama.297.14.1568.

  PMID: 17426276 BACKGROUND

• Voltarelli JC, Couri CE. Stem cell transplantation for type 1 diabetes mellitus. Diabetol Metab Syndr. 2009 Sep 16;1(1):4. doi: 10.1186/1758-5996-1-4.

  PMID: 19825196 BACKGROUND

• Effect of intensive therapy on residual beta-cell function in patients with type 1 diabetes in the diabetes control and complications trial. A randomized, controlled trial. The Diabetes Control and Complications Trial Research Group. Ann Intern Med. 1998 Apr 1;128(7):517-23. doi: 10.7326/0003-4819-128-7-199804010-00001.

  PMID: 9518395 BACKGROUND

• Couri CE, Oliveira MC, Stracieri AB, Moraes DA, Pieroni F, Barros GM, Madeira MI, Malmegrim KC, Foss-Freitas MC, Simoes BP, Martinez EZ, Foss MC, Burt RK, Voltarelli JC. C-peptide levels and insulin independence following autologous nonmyeloablative hematopoietic stem cell transplantation in newly diagnosed type 1 diabetes mellitus. JAMA. 2009 Apr 15;301(15):1573-9. doi: 10.1001/jama.2009.470.

  PMID: 19366777 BACKGROUND

• Otonkoski T, Gao R, Lundin K. Stem cells in the treatment of diabetes. Ann Med. 2005;37(7):513-20. doi: 10.1080/07853890500300279.

  PMID: 16278164 RESULT

• Cantu-Rodriguez OG, Lavalle-Gonzalez F, Herrera-Rojas MA, Jaime-Perez JC, Hawing-Zarate JA, Gutierrez-Aguirre CH, Mancias-Guerra C, Gonzalez-Llano O, Zapata-Garrido A, Villarreal-Perez JZ, Gomez-Almaguer D. Long-Term Insulin Independence in Type 1 Diabetes Mellitus Using a Simplified Autologous Stem Cell Transplant. J Clin Endocrinol Metab. 2016 May;101(5):2141-8. doi: 10.1210/jc.2015-2776. Epub 2016 Feb 9.

  PMID: 26859103 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Fernando J Lavalle, MD

  Hospital Universitario Dr. José Eleuterio González

  PRINCIPAL INVESTIGATOR

• David Gómez, MD

  Hospital Universitario Dr. José Eleuterio González

  STUDY CHAIR

• Olga G Cantú, MD

  Hospital Universitario Dr. José Eleuterio González

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Autologous Hematopoietic Stem Cell Transplantation in Type 1 Diabetes Mellitus

Study Record Dates

• First Submitted: May 11, 2010
• First Posted: May 12, 2010
• Study Start: May 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2012
• Last Updated: December 10, 2012

Record last verified: 2012-12

Locations

ME (1)