Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus

October 12, 2010 updated by: Qingdao University

Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes

The purpose of this study is to determine whether umbilical cord Mesenchymal Stem Cells of treatment for initial type 1 diabetes is safe and effective.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells.Patients require multiple daily insulin injections throughout their lives as well as close monitoring of their diet and blood sugar levels to prevent complications. The investigators hope umbilical cord Mesenchymal Stem Cells could not only address the need for β-cell replacement but also control of the autoimmune response to β cells.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Phase 2
  • Phase 1

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
    • Shandong
      • Qingdao, Shandong, China, 266003
        • Stem Cell Research Center of Medical School Hospital of Qingdao University

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

3 years to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Confirmed diagnosis of type 1 diabetes by ADA criteria less than 9 weeks.
  • Ability to provide written informed consent from patients or Child guardian.

Exclusion Criteria:

  • diabetic ketoacidosis.
  • evidence of retinopathy at baseline.
  • Body Mass Index >30.
  • Severe or acute organ damage.
  • Infectious diseases, e.g. HIV infection, or hepatitis B or C infection.
  • Severe psychiatric disorder.
  • 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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: umbilical cord mesenchymal stem cells
Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells
Biological: umbilical cord mesenchymal stem cells
Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.
Other Names:
  • mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
C peptide release test
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Exogenous insulin dose
Time Frame: 3 months
3 months
blood glucose
Time Frame: 3 months
3 months
glycosylated Hemoglobin A1c
Time Frame: 3 months
3 months
Number of severe and documented hypoglycemic events
Time Frame: 3 months
3 months
Immunologic reconstitution parameters
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Qingdao University

Investigators

  • Study Director: Yangang Wang, MD Phd, The Affiliated Hospital of Qingdao 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

September 1, 2010

Primary Completion (Anticipated)

September 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

October 12, 2010

First Submitted That Met QC Criteria

October 12, 2010

First Posted (Estimate)

October 13, 2010

Study Record Updates

Last Update Posted (Estimate)

October 13, 2010

Last Update Submitted That Met QC Criteria

October 12, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSCT1DM003

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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