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

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ClinicalTrials.gov Identifier: NCT01694173
Recruitment Status : Unknown
Verified September 2012 by Dr Vikas Sood, Postgraduate Institute of Medical Education and Research.
Recruitment status was:  Recruiting
First Posted : September 27, 2012
Last Update Posted : October 1, 2012
Sponsor:
Collaborator:
Indian Council of Medical Research
Information provided by (Responsible Party):
Dr Vikas Sood, Postgraduate Institute of Medical Education and Research

Tracking Information
First Submitted Date  ICMJE September 24, 2012
First Posted Date  ICMJE September 27, 2012
Last Update Posted Date October 1, 2012
Study Start Date  ICMJE December 2010
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
• Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline [ Time Frame: 6 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01694173 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2012)
• 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
• Any reduction in requirement of insulin dosage • Improvement of HbA1c levels as compared to baseline [ Time Frame: 6 months ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 DM
Official Title  ICMJE Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 Diabetes Mellitus
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.
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.
Study Type  ICMJE Interventional
Study Phase Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes Mellitus
Intervention  ICMJE
  • 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
  • Other: Stem cell therapy- splenic artery
    7 patients will receive stem cells infusion through splenic artery.
  • Other: Stem cell therapy-intravenous
    7 patients will receive stem cells infusion through peripheral intravenous route.
  • Other: Normal saline placebo -sham procedure
    7 patients will receive infusion of normal saline and will act as control groups
Study Arms
  • Experimental: Stem cell therapy - SPD artery
    Stem cells will be infused into the superior pancreaticoduodenal artery.
    Intervention: Other: Stem cell therapy- SPD artery
  • Active Comparator: Stem cell therapy - splenic artery
    Stem cells will be infused into the splenic artery.
    Intervention: Other: Stem cell therapy- splenic artery
  • Active Comparator: Stem cell therapy-intravenous
    Stem cells will be given intravenously.
    Intervention: Other: Stem cell therapy-intravenous
  • Placebo Comparator: Normal saline placebo -sham procedure
    Sham procedure with infusion of normal saline.
    Intervention: Other: Normal saline placebo -sham procedure
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: September 24, 2012)
28
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date February 2013
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01694173
Other Study ID Numbers  ICMJE STEM CELL PGI
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Dr Vikas Sood, Postgraduate Institute of Medical Education and Research
Study Sponsor  ICMJE Postgraduate Institute of Medical Education and Research
Collaborators  ICMJE Indian Council of Medical Research
Investigators  ICMJE
Principal Investigator: Bhagwant R Mittal, MBBS,DRM,MD Post Graduate Institute of Medical Education and Research
PRS Account Postgraduate Institute of Medical Education and Research
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP