Stem Cell Therapy for Type 2 Diabetes Mellitus
A Open Labeled and Self Controlled, Safety/Efficacy Assessed Pilot Study on Transplantation Therapy Using Bone Marrow Mesenchymal Stem Cells for Insulin Resistance of Type 2 Diabetes Mellitus
1 other identifier
interventional
24
1 country
1
Brief Summary
The purpose of the study is to evaluate the efficacy and safety in the treatment of Insulin Resistance of Type 2 Diabetes Mellitus with Bone Marrow Mesenchymal Stem Cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
Started Aug 2010
Longer than P75 for phase_1 type-2-diabetes-mellitus
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
First Submitted
Initial submission to the registry
June 10, 2010
CompletedFirst Posted
Study publicly available on registry
June 11, 2010
CompletedStudy Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJune 11, 2010
June 1, 2010
1 year
June 10, 2010
June 10, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ITT; insulin dosage; Hemoglobin A1c; Fast blood glucose (FBG) and Postmeal blood glucose (PBG); C-peptide levels; Serum Insulin levels;
1. Insulin resistance index indicated by ITT change compared with baseline. 2. Rate of reducing exogenous insulin requirement and OGLD dosage compared with baseline. 3. Hemoglobin A1c. 4. Fast blood glucose (FBG) and Postmeal blood glucose (PBG). 5. C-peptide levels. 6. Serum Insulin levels.
one year
Secondary Outcomes (1)
Serious adverse event frequency and severity
one year
Interventions
1.1st transplantation: after finishing all required examines according to protocol in Day 0, ABM-MSCs are transplanted through pancreas artery percutaneously; 2. 2nd transplantation: after finishing all required examines in Day 7±1, BM-MSCs are transplanted intravenously; 3. 3rd transplantation: after finishing all required examines in Day 14±2, BM-MSCs are transplanted intravenously.
Eligibility Criteria
You may qualify if:
- Free will taking part in the study and ability to provide written informed consent;
- Type 2 diabetes mellitus (as guideline WHO, 1999);
- Age 18-75 years old，Male/Female;
- ≤Body mass index (BMI)≤30㎏/㎡;
- Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7％;
- Intravenous insulin tolerance test（ITT）indicate patient being insulin resistance;
- Not pregnant or nursing;
- Negative pregnancy test;
- Fertile patients will use effective contraception.
You may not qualify if:
- Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction);
- Active infection requiring treatment;
- Unexplained febrile illness;
- Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Armed Police General Hospital, P.R. China
Beijing, 100085, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 10, 2010
First Posted
June 11, 2010
Study Start
August 1, 2010
Primary Completion
August 1, 2011
Study Completion
December 1, 2011
Last Updated
June 11, 2010
Record last verified: 2010-06