MedDataX Logo

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

NCT ID: NCT01694173

Last Updated: 2012-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes Mellitus

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Type 2 diabetes mellitus, F18-FDG labelled stem cells

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Stem cell therapy - SPD artery

Stem cells will be infused into the superior pancreaticoduodenal artery.

Group Type EXPERIMENTAL

Stem cell therapy- SPD artery

Intervention Type OTHER

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.

Stem cell therapy - splenic artery

Stem cells will be infused into the splenic artery.

Group Type ACTIVE_COMPARATOR

Stem cell therapy- splenic artery

Intervention Type OTHER

7 patients will receive stem cells infusion through splenic artery.

Stem cell therapy-intravenous

Stem cells will be given intravenously.

Group Type ACTIVE_COMPARATOR

Stem cell therapy-intravenous

Intervention Type OTHER

7 patients will receive stem cells infusion through peripheral intravenous route.

Normal saline placebo -sham procedure

Sham procedure with infusion of normal saline.

Group Type PLACEBO_COMPARATOR

Normal saline placebo -sham procedure

Intervention Type OTHER

7 patients will receive infusion of normal saline and will act as control groups

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Stem cell therapy- splenic artery

7 patients will receive stem cells infusion through splenic artery.

Intervention Type OTHER

Stem cell therapy-intravenous

7 patients will receive stem cells infusion through peripheral intravenous route.

Intervention Type OTHER

Normal saline placebo -sham procedure

7 patients will receive infusion of normal saline and will act as control groups

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Autologous bone marrow derived stem cells Bone marrow mononuclear cells

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indian Council of Medical Research

OTHER_GOV

Sponsor Role collaborator

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr Vikas Sood

Ph D Student, Dept of Nuclear medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bhagwant R Mittal, MBBS,DRM,MD

Role: PRINCIPAL_INVESTIGATOR

Post Graduate Institute of Medical Education and Research, Chandigarh

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

PGIMER

Chandigarh, Chandigarh, India

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

India

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Vikas Sood, MBBS, DRM

Role: CONTACT

Phone: 9779737349

Email: [email protected]

Anil Bhansali, MBBS, MD, DM

Role: CONTACT

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Vikas Sood, MBBS, DRM

Role: primary

Anil Bhansali, MBBS,MD,DM

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STEM CELL PGI

Identifier Type: -

Identifier Source: org_study_id