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

NCT ID: NCT01157403

Last Updated: 2013-06-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2014-08-31

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

Conditions

Evidence of Liver Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

mesenchymal stem cells

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

Group Type: EXPERIMENTAL

Autologous transplantation

Intervention Type: BIOLOGICAL

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

Interventions

Autologous transplantation

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

Intervention Type: BIOLOGICAL

Other Intervention Names

SWH2010A19

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lu Debin

OTHER

Sponsor Role: lead

Responsible Party

Lu Debin

Southwest Hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

chen bing, doctor

Role: STUDY_DIRECTOR

Endocrine Department, the south west Hospital of the Third Military Medical University

Locations

Endocrine Department, the south west Hospital of the Third Military Medical University

Chongqing, Chongqing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Chen bing, doctor

Role: CONTACT

903262619@qq.com

lu debin, doctor

Role: CONTACT

ldb2005056@yahoo.com.cn

Facility Contacts

Chen Bing, doctor

Role: primary

cb@mail.tmmu.com.cn

Lu Debin, doctor

Role: backup

ldb2005056@yahoo.COM.CN

Other Identifiers

ldb201001

Identifier Type: -

Identifier Source: org_study_id