Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Qingdao University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Qingdao University
ClinicalTrials.gov Identifier:
NCT01219465
First received: October 12, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted

October 12, 2010
October 12, 2010
September 2010
September 2012   (final data collection date for primary outcome measure)
C peptide release test [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • Exogenous insulin dose [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • blood glucose [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • glycosylated Hemoglobin A1c [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Number of severe and documented hypoglycemic events [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Immunologic reconstitution parameters [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes Mellitus
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Diabetes Mellitus
  • Diabetes Mellitus, Type 1
  • Mesenchymal Stem Cells
  • Umbilical Cord
Biological: umbilical cord mesenchymal stem cells
Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.
Other Name: mesenchymal stem cells
Experimental: umbilical cord mesenchymal stem cells
Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells
Intervention: Biological: umbilical cord mesenchymal stem cells
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
50
December 2012
September 2012   (final data collection date for primary outcome measure)

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.
Both
3 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01219465
MSCT1DM003
Yes
Wang, Yangang MD, Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao University
Not Provided
Study Director: Yangang Wang, MD Phd The Affiliated Hospital of Medical College of Qingdao University
Qingdao University
September 2010

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