Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2010 by University of Sao Paulo
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01322789
First received: December 7, 2010
Last updated: March 24, 2011
Last verified: November 2010
  Purpose

Type 1 diabetes mellitus results from the autoimmune destruction of the insulin producing pancreatic β-cells. The autoimmune response begins months or even years before the presentation of hyperglycemic symptoms. Previous studies with other autoimmune diseases or acute inflammatory diseases testing the effect of the infusion of mesenchymal stem cells showed promising results in regulating immune system and promoting some degree of disease control. The aim of our study is to determine the safety and efficacy of intravenous infusions of mesenchymal stem cells in newly diagnosed type 1 diabetic patients.


Condition Intervention Phase
Diabetes Mellitus, Insulin-Dependent
Biological: Intravenous Mesenchymal stem cell infusion
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • AUC C-peptide levels during mixed meal tolerance test [ Time Frame: pré-treatment, 6 months, 12 months and then yearly (course of study 7 years) ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: Every 6 months until death ] [ Designated as safety issue: Yes ]
    The process of analyzing safety data is made daily based on clinical interview, frequent physical examination and general laboratory findings weekly from the first stem cell infusion until 60 months after the last infusion. Chest X-ray will be performed in days 100, 180, 270, 360 after the lest infusion and then every 6 months. Fecal occult blood, alpha pheto protein, beta-human chorionic gonadotropin, carcino-embrionary antigen, abdomen ultrasound will be performed in month 6 and 12 after the last infusion and then yearly.


Secondary Outcome Measures:
  • Daily insulin use [ Time Frame: Daily (course of study is 7 years) ] [ Designated as safety issue: No ]
  • Hemoglobin A1C [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Anti-GAD titres [ Time Frame: Every 6 months ] [ Designated as safety issue: No ]
  • Immunologic reconstitution parameters [ Time Frame: Yearly (course of study is 7 years) ] [ Designated as safety issue: No ]

Estimated Enrollment: 10
Study Start Date: September 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intravenous mesenchymal stem cell
This group wil receive 8 intravenous infusions of mesenchymal stem cells. Four infusions 1 week apart and 4 infusions a month apart
Biological: Intravenous Mesenchymal stem cell infusion
Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart

Detailed Description:

Patients from 12 to 35 years old with type I diabetes mellitus proved by anti-pancreatic beta cell antibodies and recently diagnosed (less than 6 weeks) will be included in this study. First, bone marrow derived adult mesenchymal stem cells are collected from a first degree relative and cultured. After that, the patient receive 4 intravenous infusions 1 week apart followed by 4 infusion 4 months apart.

  Eligibility

Ages Eligible for Study:   12 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 1 diabetes mellitus diagnosed by clinical/metabolic parameters and positive anti-GAD antibodies
  • Less than 6 weeks from diagnosis

Exclusion Criteria:

  • Previous diabetic ketoacidosis
  • Pregnancy
  • Severe psychiatric disorder
  • Severe organic impairment (renal, hepatic, cardiac, pulmonary)
  • Active infectious disease
  • Previous or present neoplastic disease
  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: NCT01322789

Contacts
Contact: Julio Voltarelli, MD, PhD +55 16 2101 9369 jcvoltar@fmrp.usp.br
Contact: Carlos E Couri +5516 91495151 ce.couri@yahoo.com.br

Locations
Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo Recruiting
Ribeirão Preto, São Paulo, Brazil
Contact: Julio C Voltarelli, MD, PhD    +551621019369    jcvoltar@fmrp.usp.br   
Contact: Carlos E Couri, MD, PhD    +551691495151    ce.couri@yahoo.com.br   
Principal Investigator: Julio Voltarelli, MD, PhD         
Sub-Investigator: Carlos E Couri, MD, PhD         
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Julio Voltarelli, MD, PhD University Hospital, School of Medicine of Ribeirão Preto, Brazil
Study Chair: Carlos E Couri, MD, PhD University Hospital, School of Medicine of Ribeirão Preto, Brazil
  More Information

No publications provided

Responsible Party: Júlio Cesar Voltarelli, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT01322789     History of Changes
Other Study ID Numbers: HCFMRPUSP 2, CNPQ 552266/2005-1
Study First Received: December 7, 2010
Last Updated: March 24, 2011
Health Authority: Brazil: Conselho Nacional de Ética em Pesquisa

Keywords provided by University of Sao Paulo:
Diabetes mellitus
Stem cells
Autologous stem cell transplantation
Autoimmune diseases

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 July 23, 2014