Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 DM

Post Graduate Institute of Medical Education and Research, Chandigarh

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Type 2 Diabetes Mellitus

Treatments: Other: Stem cell therapy- splenic artery; Other: Stem cell therapy- SPD artery; Other: Stem cell therapy-intravenous; Other: Normal saline placebo -sham procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT01694173

STEM CELL PGI

Details and patient eligibility

About

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.

Full description

Autologous bone marrow derived stem cells have a promising potential in regenerative medicine. In particular the past decade has garnered a great interest in cellular therapy for treating Type2 diabetes mellitus. The pertinent questions in regenerative medicine today are to know about the homing, survival, differentiation and functionality of the cells and based on these to find out the adequate administration methods and choose the optimal dose and cell types. Various modalities have been used in the preclinical and clinical trials. These include MRI,optical imaging in the form of bioluminescence and fluorescence, quantum dots, SPECT and PET/CT imaging. However the methods which are suitable for stem cell tracking in small animals are not easily translated for human trials. In humans PET/CT imaging with its reasonable resolution and unique ability to combine anatomical and functional imaging is considered to be the best bet yet. Hence we intend to label the autologous bone marrow derived stem cells with PET tracer F18-FDG and carry out biodistribution studies, our ultimate aim being to study how in vivo distribution of the cells affect therapeutic efficacy.

Enrollment: 28 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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28 participants in 4 patient groups, including a placebo group

Stem cell therapy - SPD artery

Experimental group

Description:

Stem cells will be infused into the superior pancreaticoduodenal artery.

Treatment:

Other: Stem cell therapy- SPD artery

Stem cell therapy - splenic artery

Active Comparator group

Description:

Stem cells will be infused into the splenic artery.

Treatment:

Other: Stem cell therapy- splenic artery

Stem cell therapy-intravenous

Active Comparator group

Description:

Stem cells will be given intravenously.

Treatment:

Other: Stem cell therapy-intravenous

Normal saline placebo -sham procedure

Placebo Comparator group

Description:

Sham procedure with infusion of normal saline.

Treatment:

Other: Normal saline placebo -sham procedure