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

Qingdao University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus; Mesenchymal Stem Cells; Umbilical Cord

Treatments: Biological: umbilical cord mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01219465

MSCT1DM003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 3 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

umbilical cord mesenchymal stem cells

Experimental group

Description:

Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells

Treatment:

Biological: umbilical cord mesenchymal stem cells