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

Primary Purpose

Diabetes Mellitus, Insulin-Dependent

Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Intravenous Mesenchymal stem cell infusion
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Insulin-Dependent focused on measuring Diabetes mellitus, Stem cells, Autologous stem cell transplantation, Autoimmune diseases

Eligibility Criteria

12 Years - 35 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São PauloRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intravenous mesenchymal stem cell

Arm Description

This group wil receive 8 intravenous infusions of mesenchymal stem cells. Four infusions 1 week apart and 4 infusions a month apart

Outcomes

Primary Outcome Measures

AUC C-peptide levels during mixed meal tolerance test
Safety
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
Hemoglobin A1C
Anti-GAD titres
Immunologic reconstitution parameters

Full Information

First Posted
December 7, 2010
Last Updated
March 24, 2011
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01322789
Brief Title
Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
Official Title
Safety and Efficacy of Mesenchymal Stem Cells in Newly-diagnosed Type 1 Diabetic Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2010
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Insulin-Dependent
Keywords
Diabetes mellitus, Stem cells, Autologous stem cell transplantation, Autoimmune diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intravenous mesenchymal stem cell
Arm Type
Experimental
Arm Description
This group wil receive 8 intravenous infusions of mesenchymal stem cells. Four infusions 1 week apart and 4 infusions a month apart
Intervention Type
Biological
Intervention Name(s)
Intravenous Mesenchymal stem cell infusion
Intervention Description
Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart
Primary Outcome Measure Information:
Title
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)
Title
Safety
Description
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.
Time Frame
Every 6 months until death
Secondary Outcome Measure Information:
Title
Daily insulin use
Time Frame
Daily (course of study is 7 years)
Title
Hemoglobin A1C
Time Frame
3 months
Title
Anti-GAD titres
Time Frame
Every 6 months
Title
Immunologic reconstitution parameters
Time Frame
Yearly (course of study is 7 years)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julio Voltarelli, MD, PhD
Phone
+55 16 2101 9369
Email
jcvoltar@fmrp.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Carlos E Couri
Phone
+5516 91495151
Email
ce.couri@yahoo.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julio Voltarelli, MD, PhD
Organizational Affiliation
University Hospital, School of Medicine of Ribeirão Preto, Brazil
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos E Couri, MD, PhD
Organizational Affiliation
University Hospital, School of Medicine of Ribeirão Preto, Brazil
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo
City
Ribeirão Preto
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio C Voltarelli, MD, PhD
Phone
+551621019369
Email
jcvoltar@fmrp.usp.br
First Name & Middle Initial & Last Name & Degree
Carlos E Couri, MD, PhD
Phone
+551691495151
Email
ce.couri@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Julio Voltarelli, MD, PhD
First Name & Middle Initial & Last Name & Degree
Carlos E Couri, MD, PhD

12. IPD Sharing Statement

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

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