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

Diabetes Mellitus, Insulin-Dependent Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01322789
• Other study ID #: HCFMRPUSP 2
• Secondary ID: CNPQ 552266/2005
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: December 7, 2010
• Last updated: March 24, 2011
• Start date: September 2008
• Est. completion date: December 2015

Study information

• Verified date: November 2010
• Source: University of Sao Paulo
• Contact: Julio Voltarelli, MD, PhD
• Phone: +55 16 2101 9369
• Email: jcvoltar[@]fmrp.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Conselho Nacional de Ética em Pesquisa
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years to 35 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Insulin-Dependent
• Diabetes Mellitus, Type 1

Intervention

Biological:
• Intravenous Mesenchymal stem cell infusion
Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC C-peptide levels during mixed meal tolerance test		pré-treatment, 6 months, 12 months and then yearly (course of study 7 years)	No
Primary	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	Yes
Secondary	Daily insulin use		Daily (course of study is 7 years)	No
Secondary	Hemoglobin A1C		3 months	No
Secondary	Anti-GAD titres		Every 6 months	No
Secondary	Immunologic reconstitution parameters		Yearly (course of study is 7 years)	No