Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes

Lu Debin80 enrolled

Overview

Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for T1DM,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. Therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.

Autologous transplantation of Bone marrow mesenchymal stem cells(approximately 2.5 x 106 cells/kg body weight) intravenously

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Evidence of Liver Transplantation

Interventions

Eligibility

Sex: ALLMin age: 10 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Ability to provide written informed consent from patients or Child guardian 2. Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks • Exclusion Criteria: 1. Body Mass Index \>30 2. Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure. 3. Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction). 4. Infectious diseases, e.g. HIV infection, or hepatitis B or C infection 5. Presence of malignancy

Outcomes

Primary Outcomes

C peptide release test

The concentration of c-peptide at 90 minutes after the start of the C-peptide release test at 24 Months following the infusion or not with bone marrow mesenchymal stem cells

Time frame: 6 Months after intervention