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

Sponsor
Qingdao University (Other)
Overall Status
Unknown status
CT.gov ID
NCT01219465
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
27
Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: umbilical cord mesenchymal stem cells
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes
Study Start Date :
Sep 1, 2010
Anticipated Primary Completion Date :
Sep 1, 2012
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. C peptide release test [3 months]

    Secondary Outcome Measures

    1. Exogenous insulin dose [3 months]

    2. blood glucose [3 months]

    3. glycosylated Hemoglobin A1c [3 months]

    4. Number of severe and documented hypoglycemic events [3 months]

    5. Immunologic reconstitution parameters [3 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Stem Cell Research Center of Medical School Hospital of Qingdao University Qingdao Shandong China 266003

    Sponsors and Collaborators

    • Qingdao University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01219465
    Other Study ID Numbers:
    • MSCT1DM003
    First Posted:
    Oct 13, 2010
    Last Update Posted:
    Oct 13, 2010
    Last Verified:
    Sep 1, 2010
    Keywords provided by , ,
    Diabetes Mellitus
    Diabetes Mellitus, Type 1
    mesenchymal stem cells
    Umbilical cord
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 1

    Study Results

    No Results Posted as of Oct 13, 2010