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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01322789
Recruitment Status : Unknown
Verified November 2010 by University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : March 25, 2011
Last Update Posted : March 25, 2011
Sponsor:
Information provided by:
University of Sao Paulo

Tracking Information
First Submitted Date  ICMJE December 7, 2010
First Posted Date  ICMJE March 25, 2011
Last Update Posted Date March 25, 2011
Study Start Date  ICMJE September 2008
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
  • 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) ]
  • Safety [ Time Frame: Every 6 months until death ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2011)
  • Daily insulin use [ Time Frame: Daily (course of study is 7 years) ]
  • Hemoglobin A1C [ Time Frame: 3 months ]
  • Anti-GAD titres [ Time Frame: Every 6 months ]
  • Immunologic reconstitution parameters [ Time Frame: Yearly (course of study is 7 years) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
Official Title  ICMJE Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Insulin-Dependent
Intervention  ICMJE Biological: Intravenous Mesenchymal stem cell infusion
Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart
Study Arms  ICMJE 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
Intervention: Biological: Intravenous Mesenchymal stem cell infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 24, 2011)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2015
Estimated Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01322789
Other Study ID Numbers  ICMJE HCFMRPUSP 2
CNPQ 552266/2005-1 ( Other Grant/Funding Number: CNPQ 552266/2005-1 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Júlio Cesar Voltarelli, Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
Study Sponsor  ICMJE University of Sao Paulo
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Sao Paulo
Verification Date November 2010

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