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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Postgraduate Institute of Medical Education and Research
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Dr Vikas Sood, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier:
NCT01694173
First received: September 24, 2012
Last updated: September 28, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Other: Stem cell therapy- SPD artery
Other: Stem cell therapy- splenic artery
Other: Stem cell therapy-intravenous
Other: Normal saline placebo -sham procedure
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Postgraduate Institute of Medical Education and Research:

Primary Outcome Measures:
  • • Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • • Any reduction in requirement of insulin dosage measured as a percentage decrease from baseline • Improvement of HbA1c levels as compared to baseline [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: December 2010
Estimated Study Completion Date: February 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem cell therapy - SPD artery
Stem cells will be infused into the superior pancreaticoduodenal artery.
Other: Stem cell therapy- SPD artery
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.
Other Names:
  • Autologous bone marrow derived stem cells
  • Bone marrow mononuclear cells
Active Comparator: Stem cell therapy - splenic artery
Stem cells will be infused into the splenic artery.
Other: Stem cell therapy- splenic artery
7 patients will receive stem cells infusion through splenic artery.
Active Comparator: Stem cell therapy-intravenous
Stem cells will be given intravenously.
Other: Stem cell therapy-intravenous
7 patients will receive stem cells infusion through peripheral intravenous route.
Placebo Comparator: Normal saline placebo -sham procedure
Sham procedure with infusion of normal saline.
Other: Normal saline placebo -sham procedure
7 patients will receive infusion of normal saline and will act as control groups

Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01694173

Contacts
Contact: Vikas Sood, MBBS, DRM 9779737349 vikasvineeta@rediffmail.com
Contact: Anil Bhansali, MBBS, MD, DM anilbhansali_endocrine@rediffmail.com

Locations
India
PGIMER Recruiting
Chandigarh, India
Contact: Vikas Sood, MBBS, DRM    009779737349    vikasvineeta@rediffmail.com   
Contact: Anil Bhansali, MBBS,MD,DM    001722756583    anilbhansali_endocrine@rediffmail.com   
Sponsors and Collaborators
Postgraduate Institute of Medical Education and Research
Indian Council of Medical Research
Investigators
Principal Investigator: Bhagwant R Mittal, MBBS,DRM,MD Post Graduate Institute of Medical Education and Research
  More Information

No publications provided

Responsible Party: Dr Vikas Sood, Ph D Student, Dept of Nuclear medicine, Postgraduate Institute of Medical Education and Research
ClinicalTrials.gov Identifier: NCT01694173     History of Changes
Other Study ID Numbers: STEM CELL PGI
Study First Received: September 24, 2012
Last Updated: September 28, 2012
Health Authority: India: Ministry of Health

Keywords provided by Postgraduate Institute of Medical Education and Research:
Type 2 diabetes mellitus, F18-FDG labelled stem cells

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on July 29, 2014