Type 2 Diabetes MellitusPhase 2/3NCT01694173
Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 DM
A Phase 2/3 study testing Stem cell therapy- SPD artery, Stem cell therapy- splenic artery and Stem cell therapy-intravenous in people with Type 2 Diabetes Mellitus, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Stem cell therapy- SPD artery, Stem cell therapy- splenic artery and Stem cell therapy-intravenous
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2010to Feb 2013
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- History of malignancy
- Patients with active infections.
- Female patients who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
Anil Bhansali, MBBS, MD, DM contact
India1 site, 1 recruiting
- Recruiting
PGIMER
Chandigarh, Chandigarh
Vikas Sood, MBBS, DRM, 009779737349, vikasvineeta@rediffmail.com
Anil Bhansali, MBBS,MD,DM, 001722756583, anilbhansali_endocrine@rediffmail.com
About this study
Official title: Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 Diabetes Mellitus
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Stem cell therapy- SPD artery, Stem cell therapy- splenic artery, Stem cell therapy-intravenous, Normal saline placebo -sham procedure
- Keywords
- Type 2 diabetes mellitus, F18-FDG labelled stem cells
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem cell therapy- SPD arteryOther
Also called Autologous bone marrow derived stem cells, Bone marrow mononuclear cells
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 arteryOther
7 patients will receive stem cells infusion through splenic artery.
Stem cell therapy-intravenousOther
7 patients will receive stem cells infusion through peripheral intravenous route.
Normal saline placebo -sham procedureOther
7 patients will receive infusion of normal saline and will act as control groups
| Study group | Role | What they receive |
|---|---|---|
| Stem cell therapy - SPD artery | Experimental | Stem cells will be infused into the superior pancreaticoduodenal artery. Receives: Other: Stem cell therapy- SPD artery |
| Stem cell therapy - splenic artery | Active comparator | Stem cells will be infused into the splenic artery. Receives: Other: Stem cell therapy- splenic artery |
| Stem cell therapy-intravenous | Active comparator | Stem cells will be given intravenously. Receives: Other: Stem cell therapy-intravenous |
| Normal saline placebo -sham procedure | Placebo comparator | Sham procedure with infusion of normal saline. Receives: Other: Normal saline placebo -sham procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline
Measured: 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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startDec 2010
- Primary completionAug 2012
- Study completionFeb 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, Dr Vikas Sood, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Bhagwant R Mittal, MBBS,DRM,MD, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694173
- Sponsor's protocol ID
- STEM CELL PGI
- Status last verified
- Sep 2012
- First submitted
- 24 Sep 2012
- Last updated
- 1 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tissue Distribution of F18-FDG Labelled Autologous Bone Marrow Derived Stem Cells in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01694173
- Acronym / sponsor ID
- STEM CELL PGI
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Type 2 diabetes mellitus, F18-FDG labelled stem cells
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- Dec 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Feb 2013 (estimated)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stem cell therapy - SPD artery | Experimental | Other: Stem cell therapy- SPD arteryStem cells will be infused into the superior pancreaticoduodenal artery. |
| Stem cell therapy - splenic artery | Active comparator | Other: Stem cell therapy- splenic arteryStem cells will be infused into the splenic artery. |
| Stem cell therapy-intravenous | Active comparator | Other: Stem cell therapy-intravenousStem cells will be given intravenously. |
| Normal saline placebo -sham procedure | Placebo comparator | Other: Normal saline placebo -sham procedureSham procedure with infusion of normal saline. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stem cell therapy- SPD arteryAlso: Autologous bone marrow derived stem cells, Bone marrow mononuclear cellsA 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 | Stem cell therapy - SPD artery |
| Stem cell therapy- splenic artery7 patients will receive stem cells infusion through splenic artery. | Other | Stem cell therapy - splenic artery |
| Stem cell therapy-intravenous7 patients will receive stem cells infusion through peripheral intravenous route. | Other | Stem cell therapy-intravenous |
| Normal saline placebo -sham procedure7 patients will receive infusion of normal saline and will act as control groups | Other | Normal saline placebo -sham procedure |
Primary outcome
• Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline
Time frame: 6 months
1 secondary outcome
• 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anil Bhansali, MBBS, MD, DM contact
Bhagwant R Mittal, MBBS,DRM,MD principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Stem cell therapy- SPD artery, Stem cell therapy- splenic artery and Stem cell therapy-intravenous in people with Type 2 Diabetes Mellitus, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vikas Sood, MBBS, DRM (9779737349, vikasvineeta@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2012.