Clinical Trial: Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation for Type 1 Diabetes With Diabetic Ketoacidosis

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: The Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation to Treat New-onset Type 1 Diabetes With Diabetic Ketoacidosis

Brief Summary: This is a phase II trial in individuals who have been diagnosed with type 1 diabetes within the previous 12 months and suffered from diabetic ketoacidosis at onset of disease. The purpose of this study is to determine whether allogeneic umbilical cord mesenchymal stem cell transplantation is effective in the treatment of patients with severe type 1 diabetes.

Detailed Summary: To assess the clinical efficacy of allogeneic umbilical cord mesenchymal stem cell transplantation in the treatment of patients with severe type 1 diabetes, defined as with the history of diabetic ketoacidosis from diagnosis. All the patients are intravenously administrated with single-dose or double-dose umbilical cord mesenchymal stem cell and followed up for 36 months. Clinical and laboratory manifestations are compared before and after transplantation.
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Current Primary Outcome: Changes from baseline exogenous insulin dose at different time points post treatment [ Time Frame: 1 month, 3 months,6 months, 12 months, 24 months, 36 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • C-peptide level [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months ]
  • HbA1c level [ Time Frame: 1 month, 3 months, 6 months, 12 months, 24 months, 36 months ]
  • titres of islet antigen antibodies [ Time Frame: 1 month, 3 months, 6 months, 12 months,24 months, 36 months ]


Original Secondary Outcome: Same as current

Information By: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Dates:
Date Received: April 19, 2016
Date Started: January 2009
Date Completion: December 2019
Last Updated: May 4, 2016
Last Verified: May 2016