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

Primary Purpose

Evidence of Liver Transplantation

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Autologous transplantation
Sponsored by
Lu Debin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Evidence of Liver Transplantation focused on measuring mesenchymal stem cells

Eligibility Criteria

10 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endocrine Department, the south west Hospital of the Third Military Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

mesenchymal stem cells

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 2, 2010
Last Updated
June 15, 2013
Sponsor
Lu Debin
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1. Study Identification

Unique Protocol Identification Number
NCT01157403
Brief Title
Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
Official Title
Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
August 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Lu Debin

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Evidence of Liver Transplantation
Keywords
mesenchymal stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
mesenchymal stem cells
Arm Type
Experimental
Arm Description
To study the safety and efficacy of autologous transplantation of bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.
Intervention Type
Biological
Intervention Name(s)
Autologous transplantation
Other Intervention Name(s)
SWH2010A19
Intervention Description
Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously
Primary Outcome Measure Information:
Title
C peptide release test
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to provide written informed consent from patients or Child guardian Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks • Exclusion Criteria: Body Mass Index >30 Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure. Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction). Infectious diseases, e.g. HIV infection, or hepatitis B or C infection Presence of malignancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen bing, doctor
Email
903262619@qq.com
First Name & Middle Initial & Last Name or Official Title & Degree
lu debin, doctor
Email
ldb2005056@yahoo.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chen bing, doctor
Organizational Affiliation
Endocrine Department, the south west Hospital of the Third Military Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Endocrine Department, the south west Hospital of the Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chen Bing, doctor
Email
cb@mail.tmmu.com.cn
First Name & Middle Initial & Last Name & Degree
Lu Debin, doctor
Email
ldb2005056@yahoo.COM.CN

12. IPD Sharing Statement

Learn more about this trial

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

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