Tissue Distribution of F18-FDG Labeled ABMSCT in Patients With Type2 Diabetes Mellitus
1 other identifier
interventional
21
0 countries
N/A
Brief Summary
Stem cells have promising potential in treating diabetes. However the therapeutic outcome in diabetic patients will profoundly depend on their delivery to pancreas. Our objective is to label stem cells with PET tracer F18-FDG to carry out in vivo cell tracking. The labeled stem cells will be given through different routes (intravenous and intraarterial)and tissue distribution studied. Patients will be followed up for the next 6 months. Glucagon stimulated C peptide will be measured at baseline and at 6 months and HOMA IR and HOMA beta will be calculated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Dec 2010
Typical duration for phase_1
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
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
October 19, 2015
CompletedFirst Posted
Study publicly available on registry
October 23, 2015
CompletedOctober 23, 2015
October 1, 2015
1.5 years
October 19, 2015
October 22, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Increase in glucagon stimulated C peptide level
6 months
Study Arms (3)
Intravenous
ACTIVE COMPARATORstem cells will be injected through intravenously in the subjects
superior pancreaticoduodenal
ACTIVE COMPARATORstem cells
splenic artery
ACTIVE COMPARATORstem cells will be injected through splenic in the subjects
Interventions
Eligibility Criteria
You may qualify if:
- Patients with type 2 diabetes mellitus between 30 and 65 years of age.
- Duration of diabetes ≥ 5 years.
- Failure to triple OHA in optimal doses {glimepiride (4 gm), metformin(2-2.5 gm) and pioglitazone(15mg)}.
- Requiring insulin therapy for last six month
- On stable doses of insulin (≥0.4 IU/kg/day, Vildagliptin, metformin (2 gm), pioglitazone (15mg) for last three months.
- GAD antibody negative status.
You may not qualify if:
- Patients with type 1 diabetes mellitus or secondary diabetes
- Patients with serum creatinine \> 1.5 mg/dL
- Abnormal liver function tests (defined as value of transaminases \> 3 times the upper value of normal or serum bilirubin higher than normal for the reference value for the laboratory).
- History of cholecystitis/ cholelithiasis/ cholecystectomy.
- Seropositivity for HIV, HBsAg and HCV.
- History of myocardial infarction or unstable angina or any cardiovascular events in the previous 3 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head, Dept of Endocrinology
Study Record Dates
First Submitted
October 19, 2015
First Posted
October 23, 2015
Study Start
December 1, 2010
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
October 23, 2015
Record last verified: 2015-10