Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation for Type 1 Diabetes With Diabetic Ketoacidosis
UCMSCDKA
The Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cell Transplantation to Treat New-onset Type 1 Diabetes With Diabetic Ketoacidosis
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jan 2009
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 19, 2016
CompletedFirst Posted
Study publicly available on registry
May 5, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedMay 5, 2016
May 1, 2016
10.9 years
April 19, 2016
May 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (1)
umbilical cord mesenchymal stem cell
EXPERIMENTALsingle- or double-dose intravenous injection of umbilical cord mesenchymal stem cells for the treatment of severe type 1 diabetes patients
Interventions
allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection
Eligibility Criteria
You may qualify if:
- Type 1 diabetes
- Duration of disease less than 12 months from diagnosis
- With the history of diabetic ketoacidosis
You may not qualify if:
- Pregnancy
- Severe psychiatric disorder
- Severe organic impairment(renal,hepatic,cardiac,pulmonary)
- Active infectious disease
- Previous or present neoplastic disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008, China
Related Publications (1)
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.
PMID: 35941696DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dalong Zhu, MD.PhD.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Chief Physician, Professor, Director of Endocrinology Department
Study Record Dates
First Submitted
April 19, 2016
First Posted
May 5, 2016
Study Start
January 1, 2009
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
May 5, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share