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

June 15, 2013 updated by: Lu Debin
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • Recruiting
        • Endocrine Department, the south west Hospital of the Third Military Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 40 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Autologous transplantation
Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously
Other Names:
  • SWH2010A19

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
C peptide release test
Time Frame: 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
6 Months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lu Debin

Investigators

  • Study Director: chen bing, doctor, Endocrine Department, the south west Hospital of the Third Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

August 1, 2014

Study Registration Dates

First Submitted

July 2, 2010

First Submitted That Met QC Criteria

July 6, 2010

First Posted (Estimate)

July 7, 2010

Study Record Updates

Last Update Posted (Estimate)

June 18, 2013

Last Update Submitted That Met QC Criteria

June 15, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ldb201001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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