Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 DM
1 other identifier
interventional
28
1 country
1
Brief Summary
Investigators purpose is to track stem cells in vivo in the type 2 diabetes mellitus patients after the same have been labelled with positron emission tomography tracer F18-FDG; as it is assumed that the therapeutic outcome will profoundly depend on the delivery of these cells to pancreas. Biodistribution and quantification studies will be done at 30 minutes and 90 minutes of stem cell infusion.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 type-2-diabetes-mellitus
Started Dec 2010
Longer than P75 for phase_2 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
Study Start
First participant enrolled
December 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 24, 2012
CompletedFirst Posted
Study publicly available on registry
September 27, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedOctober 1, 2012
September 1, 2012
1.7 years
September 24, 2012
September 28, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
• Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline
6 months
Secondary Outcomes (1)
• Any reduction in requirement of insulin dosage measured as a percentage decrease from baseline • Improvement of HbA1c levels as compared to baseline
6 months
Study Arms (4)
Stem cell therapy - SPD artery
EXPERIMENTALStem cells will be infused into the superior pancreaticoduodenal artery.
Stem cell therapy - splenic artery
ACTIVE COMPARATORStem cells will be infused into the splenic artery.
Stem cell therapy-intravenous
ACTIVE COMPARATORStem cells will be given intravenously.
Normal saline placebo -sham procedure
PLACEBO COMPARATORSham procedure with infusion of normal saline.
Interventions
A total of 28 patients will be enrolled and randomized to four groups of 7 patients each. 7 patients will receive stem cell infusion into the superior pancreaticoduodenal artery. Another 7 patients will be given stem cell infusion into the splenic artery. The next batch of 7 patients will receive stem cell infusion from the peripheral intravenous route and 7 patients will act as controls undergoing a sham procedure with infusion of normal saline.
7 patients will receive stem cells infusion through splenic artery.
7 patients will receive stem cells infusion through peripheral intravenous route.
7 patients will receive infusion of normal saline and will act as control groups
Eligibility Criteria
You may qualify if:
- Patients with T2DM between 30 and 70 years of age.
- Failure to triple OHA and on stable doses of insulin for at least 3 months.
- On vildagliptin, pioglitazone and metformin for at least 3 months along with Insulin to maintain euglycemia.
- HbA1c of 6.5-7.5%
- Insulin requirement ≥0.4 IU/kg/d.
- Glutamic acid decarboxylase (GAD 65) antibody negative status.
You may not qualify if:
- Patients with T1DM 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 pancreatitis
- Seropositivity for HIV, HBsAg and HCV.
- History of myocardial infarction or unstable angina in the previous 3 months.
- History of malignancy
- Patients with active infections.
- Female patients who are pregnant or lactating
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
PGIMER
Chandigarh, Chandigarh, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bhagwant R Mittal, MBBS,DRM,MD
Post Graduate Institute of Medical Education and Research, Chandigarh
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ph D Student, Dept of Nuclear medicine
Study Record Dates
First Submitted
September 24, 2012
First Posted
September 27, 2012
Study Start
December 1, 2010
Primary Completion
August 1, 2012
Study Completion
February 1, 2013
Last Updated
October 1, 2012
Record last verified: 2012-09