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

NCT ID: NCT01322789

Last Updated: 2011-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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.

Conditions

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Diabetes Mellitus, Insulin-Dependent

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Intravenous Mesenchymal stem cell infusion

Intervention Type BIOLOGICAL

Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart

Interventions

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Intravenous Mesenchymal stem cell infusion

Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Principal Investigators

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Julio Voltarelli, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, School of Medicine of Ribeirão Preto, Brazil

Carlos E Couri, MD, PhD

Role: STUDY_CHAIR

University Hospital, School of Medicine of Ribeirão Preto, Brazil

Locations

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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo

Ribeirão Preto, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Julio Voltarelli, MD, PhD

Role: CONTACT

+55 16 2101 9369

Carlos E Couri

Role: CONTACT

+5516 91495151

Facility Contacts

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Julio C Voltarelli, MD, PhD

Role: primary

+551621019369

Carlos E Couri, MD, PhD

Role: backup

+551691495151

Other Identifiers

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CNPQ 552266/2005-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

HCFMRPUSP 2

Identifier Type: -

Identifier Source: org_study_id

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