Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus

Phase 1

• Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 1; Mesenchymal Stem Cells; Umbilical Cord
• Interventions: Biological: umbilical cord mesenchymal stem cells

• Registration Number: NCT01219465
• Lead Sponsor: Qingdao University

Brief Summary

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.

Detailed Description

Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-09
• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-12
• Last Update Submitted: 2010-10-12
• Study First Posted: 2010-10-13
• Last Update Posted: 2010-10-13
• Primary Completion: 2012-09
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
• Ability to provide written informed consent from patients or Child guardian.

Exclusion Criteria

• diabetic ketoacidosis.
• evidence of retinopathy at baseline.
• Body Mass Index >30.
• Severe or acute organ damage.
• Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
• Severe psychiatric disorder.
• Presence of malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
umbilical cord mesenchymal stem cells	umbilical cord mesenchymal stem cells	Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
C peptide release test	3 months

Secondary Outcome Measures

Name	Time	Method
Immunologic reconstitution parameters	3 months
Exogenous insulin dose	3 months
blood glucose	3 months
glycosylated Hemoglobin A1c	3 months
Number of severe and documented hypoglycemic events	3 months

Trial Locations

Locations (1)

Stem Cell Research Center of Medical School Hospital of Qingdao University; 🇨🇳 Qingdao, Shandong, China