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

Phase 2

• Conditions: Evidence of Liver Transplantation
• Interventions: Biological: Autologous transplantation

• Registration Number: NCT01157403
• Lead Sponsor: Lu Debin

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2010-07
• Study First Submitted: 2010-07-02
• Study First Submitted QC: 2010-07-06
• Study First Posted: 2010-07-07
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-15
• Last Update Posted: 2013-06-18
• Primary Completion: 2014-07
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mesenchymal stem cells	Autologous transplantation	To study the safety and efficacy of autologous transplantation of bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.

Primary Outcome Measures

Name	Time	Method
C peptide release test	6 Months after intervention	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

Trial Locations

Locations (1)

Endocrine Department, the south west Hospital of the Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China