Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation for Type 1 Diabetes With Diabetic Ketoacidosis (UCMSCDKA)
Primary Purpose
Ketoacidosis, Diabetic
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
umbilical cord mesenchymal stem cell
Sponsored by
About this trial
This is an interventional treatment trial for Ketoacidosis, Diabetic focused on measuring umbilical cord stem cell, diabetic ketoacidosis
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
Sites / Locations
- The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
umbilical cord mesenchymal stem cell
Arm Description
single- or double-dose intravenous injection of umbilical cord mesenchymal stem cells for the treatment of severe type 1 diabetes patients
Outcomes
Primary Outcome Measures
Changes from baseline exogenous insulin dose at different time points post treatment
Secondary Outcome Measures
C-peptide level
HbA1c level
titres of islet antigen antibodies
Full Information
NCT ID
NCT02763423
First Posted
April 19, 2016
Last Updated
May 4, 2016
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
1. Study Identification
Unique Protocol Identification Number
NCT02763423
Brief Title
Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation for Type 1 Diabetes With Diabetic Ketoacidosis
Acronym
UCMSCDKA
Official Title
The Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation to Treat New-onset Type 1 Diabetes With Diabetic Ketoacidosis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketoacidosis, Diabetic
Keywords
umbilical cord stem cell, diabetic ketoacidosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
umbilical cord mesenchymal stem cell
Arm Type
Experimental
Arm Description
single- or double-dose intravenous injection of umbilical cord mesenchymal stem cells for the treatment of severe type 1 diabetes patients
Intervention Type
Procedure
Intervention Name(s)
umbilical cord mesenchymal stem cell
Intervention Description
allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
C-peptide level
Time Frame
1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Title
HbA1c level
Time Frame
1 month, 3 months, 6 months, 12 months, 24 months, 36 months
Title
titres of islet antigen antibodies
Time Frame
1 month, 3 months, 6 months, 12 months,24 months, 36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dalong Zhu, MD.PhD.
Phone
86-25-83106666
Ext
61430
Email
zhudalong@nju.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dalong Zhu, MD.PhD.
Organizational Affiliation
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dalong Zhu, MD.PhD.
Phone
86-25-83106666
Ext
61430
Email
zhudalong@nju.edu.cn
First Name & Middle Initial & Last Name & Degree
Jing Lu, PhD.
Phone
86-25-83106666
Ext
61431
Email
qiusnow16@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35941696
Citation
Zhang W, Ling Q, Wang B, Wang K, Pang J, Lu J, Bi Y, Zhu D. Comparison of therapeutic effects of mesenchymal stem cells from umbilical cord and bone marrow in the treatment of type 1 diabetes. Stem Cell Res Ther. 2022 Aug 8;13(1):406. doi: 10.1186/s13287-022-02974-1.
Results Reference
derived
Learn more about this trial
Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation for Type 1 Diabetes With Diabetic Ketoacidosis
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