Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 5 of 227 for:    stem cell diabetes

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01219465
Recruitment Status : Unknown
Verified September 2010 by Qingdao University.
Recruitment status was:  Active, not recruiting
First Posted : October 13, 2010
Last Update Posted : October 13, 2010
Sponsor:
Information provided by:
Qingdao University

Tracking Information
First Submitted Date  ICMJE October 12, 2010
First Posted Date  ICMJE October 13, 2010
Last Update Posted Date October 13, 2010
Study Start Date  ICMJE September 2010
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
C peptide release test [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2010)
  • Exogenous insulin dose [ Time Frame: 3 months ]
  • blood glucose [ Time Frame: 3 months ]
  • glycosylated Hemoglobin A1c [ Time Frame: 3 months ]
  • Number of severe and documented hypoglycemic events [ Time Frame: 3 months ]
  • Immunologic reconstitution parameters [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus
Official Title  ICMJE Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 1
  • Mesenchymal Stem Cells
  • Umbilical Cord
Intervention  ICMJE Biological: umbilical cord mesenchymal stem cells
Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.
Other Name: mesenchymal stem cells
Study Arms  ICMJE Experimental: umbilical cord mesenchymal stem cells
Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells
Intervention: Biological: umbilical cord mesenchymal stem cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 12, 2010)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 35 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01219465
Other Study ID Numbers  ICMJE MSCT1DM003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
Study Sponsor  ICMJE Qingdao University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yangang Wang, MD Phd The Affiliated Hospital of Medical College of Qingdao University
PRS Account Qingdao University
Verification Date September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP