Autologous Transplantation of Mesenchymal Stem Cells for Treatment of Patients With Onset of Type 1 Diabetes
1 other identifier
interventional
80
1 country
1
Brief Summary
Type 1 diabetes mellitus (T1DM)is characterized by the autoimmune destruction of the pancreatic β cells; as a result, patients with T1DM are dependent on exogenous insulin to control their blood glucose continuously. Bone marrow-derived mesenchymal stem cells has been shown in many animal studies their potential cure for T1DM,which could not only address the need for β-cell replacement but also control of the autoimmune response to cells which express insulin. Therefore it is need to study the safety and efficacy of autologous bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2010
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2010
CompletedFirst Submitted
Initial submission to the registry
July 2, 2010
CompletedFirst Posted
Study publicly available on registry
July 7, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJune 18, 2013
June 1, 2013
4 years
July 2, 2010
June 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
C peptide release test
The concentration of c-peptide at 90 minutes after the start of the C-peptide release test at 24 Months following the infusion or not with bone marrow mesenchymal stem cells
6 Months after intervention
Study Arms (1)
mesenchymal stem cells
EXPERIMENTALTo study the safety and efficacy of autologous transplantation of bone marrow mesenchymal stem cells in treatment of newly diagnosed patients with T1DM.
Interventions
Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously
Eligibility Criteria
You may qualify if:
- Ability to provide written informed consent from patients or Child guardian
- Confirmed diagnosis of type 1 diabetes by ADA criteria less than 18 weeks •
You may not qualify if:
- Body Mass Index \>30
- Presence of acute stage as Active infection,recent myocardial infarction, recent cerebral vascular accident (CVA) or acute renal failure.
- Severe Organ damage(e.g. lung disease, or hematopoietic dysfunction, or liver dysfunction).
- Infectious diseases, e.g. HIV infection, or hepatitis B or C infection
- Presence of malignancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lu Debinlead
Study Sites (1)
Endocrine Department, the south west Hospital of the Third Military Medical University
Chongqing, Chongqing Municipality, 400038, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
chen bing, doctor
Endocrine Department, the south west Hospital of the Third Military Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Southwest Hospital
Study Record Dates
First Submitted
July 2, 2010
First Posted
July 7, 2010
Study Start
July 1, 2010
Primary Completion
July 1, 2014
Study Completion
August 1, 2014
Last Updated
June 18, 2013
Record last verified: 2013-06