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

Ketoacidosis, Diabetic Clinical Trial

— UCMSCDKA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02763423
• Other study ID #: NJGYNFM-SC-02
• Status: Recruiting
• Phase: Phase 2
• First received: April 19, 2016
• Last updated: May 4, 2016
• Start date: January 2009
• Est. completion date: December 2019

Study information

• Verified date: May 2016
• Source: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
• Contact: Dalong Zhu, MD.PhD.
• Phone: 86-25-83106666
• Email: zhudalong[@]nju.edu.cn
• Is FDA regulated: No
• Health authority: China: Jiangsu Provincial Commission of Health and Family Planning
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 35 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Ketoacidosis
• Ketoacidosis, Diabetic

Intervention

Procedure:
• umbilical cord mesenchymal stem cell
allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection

Locations

Country	Name	City	State
China	The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline exogenous insulin dose at different time points post treatment		1 month, 3 months,6 months, 12 months, 24 months, 36 months	No
Secondary	C-peptide level		1 month, 3 months, 6 months, 12 months, 24 months, 36 months	No
Secondary	HbA1c level		1 month, 3 months, 6 months, 12 months, 24 months, 36 months	No
Secondary	titres of islet antigen antibodies		1 month, 3 months, 6 months, 12 months,24 months, 36 months	No