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

Study Overview
=================
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.

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

Conditions
-----------------
Ketoacidosis, Diabetic

Intervention / Treatment
-----------------
* Procedure: umbilical cord mesenchymal stem cell


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: umbilical cord mesenchymal stem cell<br>single- or double-dose intravenous injection of umbilical cord mesenchymal stem cells for the treatment of severe type 1 diabetes patients | Procedure: umbilical cord mesenchymal stem cell<br>* allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-peptide level |  | 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 | 
| titres of islet antigen antibodies |  | 1 month, 3 months, 6 months, 12 months,24 months, 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
umbilical cord stem cell, diabetic ketoacidosis