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

Sponsor

University of Sao Paulo (Other)

Overall Status

Unknown status

CT.gov ID

NCT01322789

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

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

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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2008

Anticipated Primary Completion Date :

Nov 1, 2015

Anticipated Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

AUC C-peptide levels during mixed meal tolerance test [pré-treatment, 6 months, 12 months and then yearly (course of study 7 years)]
Safety [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.

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo	Ribeirão Preto	São Paulo	Brazil

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