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

Phase 2

• Conditions: Ketoacidosis, Diabetic
• Interventions: Procedure: umbilical cord mesenchymal stem cell

• Registration Number: NCT02763423
• Lead Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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 Description

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2016-04-19
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-04
• Last Update Submitted: 2016-05-04
• Study First Posted: 2016-05-05
• Last Update Posted: 2016-05-05
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Type 1 diabetes
• Duration of disease less than 12 months from diagnosis
• With the history of diabetic ketoacidosis

Exclusion Criteria

• Pregnancy
• Severe psychiatric disorder
• Severe organic impairment(renal,hepatic,cardiac,pulmonary)
• Active infectious disease
• Previous or present neoplastic disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
umbilical cord mesenchymal stem cell	umbilical cord mesenchymal stem cell	single- or double-dose intravenous injection of umbilical cord mesenchymal stem cells for the treatment of severe type 1 diabetes patients

Primary Outcome Measures

Name	Time	Method
Changes from baseline exogenous insulin dose at different time points post treatment	1 month, 3 months,6 months, 12 months, 24 months, 36 months

Secondary Outcome Measures

Name	Time	Method
titres of islet antigen antibodies	1 month, 3 months, 6 months, 12 months,24 months, 36 months
HbA1c level	1 month, 3 months, 6 months, 12 months, 24 months, 36 months
C-peptide level	1 month, 3 months, 6 months, 12 months, 24 months, 36 months

Trial Locations

Locations (1)

The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China