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

Evidence of Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01157403
• Other study ID #: ldb201001
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 2, 2010
• Last updated: June 15, 2013
• Start date: July 2010
• Est. completion date: August 2014

Study information

• Verified date: June 2013
• Source: Third Military Medical University
• Contact: Chen bing, doctor
• Email: 903262619[@]qq.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 40 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Evidence of Liver Transplantation

Intervention

Biological:
• Autologous transplantation
Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously

Locations

Country	Name	City	State
China	Endocrine Department, the south west Hospital of the Third Military Medical University	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Lu Debin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 Months after intervention	No