NCT01322789

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Sep 2008

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2010

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 25, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

March 25, 2011

Status Verified

November 1, 2010

Enrollment Period

7.2 years

First QC Date

December 7, 2010

Last Update Submit

March 24, 2011

Conditions

Diabetes Mellitus, Insulin-Dependent

Keywords

Diabetes mellitusStem cellsAutologous stem cell transplantationAutoimmune diseases

Outcome Measures

Primary Outcomes (2)

  • AUC C-peptide levels during mixed meal tolerance test

    pré-treatment, 6 months, 12 months and then yearly (course of study 7 years)

  • 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.

    Every 6 months until death

Secondary Outcomes (4)

  • Daily insulin use

    Daily (course of study is 7 years)

  • Hemoglobin A1C

    3 months

  • Anti-GAD titres

    Every 6 months

  • Immunologic reconstitution parameters

    Yearly (course of study is 7 years)

Study Arms (1)

Intravenous mesenchymal stem cell

EXPERIMENTAL

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

Interventions

Intravenous Mesenchymal stem cell infusionBIOLOGICAL

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

Intravenous mesenchymal stem cell

Eligibility Criteria

Age12 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Ribeirão Preto, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusAutoimmune Diseases

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesImmune System Diseases

Study Officials

  • Julio Voltarelli, MD, PhD

    University Hospital, School of Medicine of Ribeirão Preto, Brazil

    PRINCIPAL INVESTIGATOR

  • Carlos E Couri, MD, PhD

    University Hospital, School of Medicine of Ribeirão Preto, Brazil

    STUDY CHAIR

Central Study Contacts

Julio Voltarelli, MD, PhD

CONTACT

+55 16 2101 9369jcvoltar@fmrp.usp.br

Carlos E Couri

CONTACT

+5516 91495151ce.couri@yahoo.com.br

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 7, 2010

First Posted

March 25, 2011

Study Start

September 1, 2008

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

March 25, 2011

Record last verified: 2010-11

Locations

BR(1)