Type 2 Diabetes MellitusNCT01065298
Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2
An observational study of Type 2 Diabetes Mellitus, run by Post Graduate Institute of Medical Education and Research, Chandigarh at 1 site in India.
Trial summary
The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- stem cell transplantation
- Type of treatment
- Injection or infusion
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Nov 2009to Jul 2011
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with type 2 Diabetes mellitus with triple Oral hypoglycemic failure and on Insulin for glycemic control
Who may be able to join
- Patients with type 2 diabetes mellitus between 30 and 70 years of age.
- Failure to triple OHA and on stable doses of insulin for atleast 3 months.
- On vildagliptin,pioglitazone and metformin for atleast 3 months along with Insulin to maintain euglycemia.
- HbA1c < 8.5%.
- Insulin requirement ≥0.4 IU/kg/d.
- GAD 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 cholecystitis/ cholelitiasis/ cholecystectomy
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Post Graduate Institute of Medical Education and Research
Chandigarh, Chandigarh UT
About this study
Official title: Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus
The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.
Read the detailed description
We hypothesize that Autologous bone marrow derived stem cell transplantation(ABMSCT)into the pancreas of patients with T2DM, aged 30 - 70 years with triple oral hypoglycemic agent failure and on insulin(>0.4 U/ kg body weight/day) will lead to abolition or reduction of insulin requirement by more than or equal to 50% in these patients over a period of 6 months. It is assumed that ABMSCT in these patients leads to increased angiogenesis, secretion of various cytokines and upregulation of pancreatic transcription factors and Vascular endothelial growth factor(VEGF) and creates a microenvironment which supports beta cell/resident stem cell activation and survival.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- stem cell transplantation
- 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 transplantationBiological
Also called Autologous Bone marrow derived stem cell transplantation
Group 1: 200 - 250 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - Hyperaque) and stem cells will be separated. Separated MNC's will be tagged with FDG-PET and injected into superior pancreatico duodenal artery and an PET scan will be done 2 hours later to see the percentage of stem cells homing in to pancreas. After 8 weeks G-CSF(10mcg/Kg/day) will be given subcutaneous for 5 days to achieve a Leucocyte count of >40,000/mm3. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide, plasma Insulin, HOMA-IR , HOMA-B ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
| Study group | Role | What they receive |
|---|---|---|
| Group 1:Stem cell Recipient | Patients with Type 2 Diabetes mellitus on full doses of Vildagliptin+Pioglitazone+Metformin and requiring Insulin at dose of >0.4U/Kg for blood glucose control. They will undergo stem cell therapy initialy and G-CSF therapy at 2 months Receives: Biological: stem cell transplantation | |
| Group-2: Controls | Type 2 Diabetes mellitus patients on full doses of vildagliptin+metformin+pioglitazone and on Insulin >0.4U/Kg who will act as active control.They will receive injectable placebo at Day 1 in addition to above and will be followed up for 6 months.Follow up investigation and Insulin dose titration will be similar to Group 1. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels .
Measured: 6 months
Secondary outcomes (1)
Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls.
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 posted9 Feb 2010 (estimated)
- Study startNov 2009
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil Bhansali, Post Graduate Institute of Medical Education and Research, Chandigarh
- Investigators
- Anil Bhansali, MD.,DM, Study chair, Post Graduate Institute of Medical Education and Research, ChandigarhNeelam Marwaha, MD.,DM, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhN Khandelwal, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhB.R. Mittal, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhPrem Kumar, MD, Principal investigator, Post Graduate Institute of Medical Education and Research, ChandigarhRama Walia, MD.,DM, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065298
- Sponsor's protocol ID
- ABMSCT2
- Status last verified
- Oct 2015
- First submitted
- 8 Feb 2010
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bhansali A, Upreti V, Khandelwal N, Marwaha N, Gupta V, Sachdeva N, Sharma RR, Saluja K, Dutta P, Walia R, Minz R, Bhadada S, Das S, Ramakrishnan S. Efficacy of autologous bone marrow-derived stem cell transplantation in patients with type 2 diabetes mellitus. Stem Cells Dev. 2009 Dec;18(10):1407-16. doi: 10.1089/scd.2009.0164.
PubMed 19686048
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT01065298
- Acronym / sponsor ID
- ABMSCT2
- Conditions
- Type 2 Diabetes Mellitus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 9 Feb 2010 (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.
The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.
Detailed description
We hypothesize that Autologous bone marrow derived stem cell transplantation(ABMSCT)into the pancreas of patients with T2DM, aged 30 - 70 years with triple oral hypoglycemic agent failure and on insulin(>0.4 U/ kg body weight/day) will lead to abolition or reduction of insulin requirement by more than or equal to 50% in these patients over a period of 6 months. It is assumed that ABMSCT in these patients leads to increased angiogenesis, secretion of various cytokines and upregulation of pancreatic transcription factors and Vascular endothelial growth factor(VEGF) and creates a microenvironment which supports beta cell/resident stem cell activation and survival.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1:Stem cell Recipient | – | Biological: stem cell transplantationPatients with Type 2 Diabetes mellitus on full doses of Vildagliptin+Pioglitazone+Metformin and requiring Insulin at dose of >0.4U/Kg for blood glucose control. They will undergo stem cell therapy initialy and G-CSF therapy at 2 months |
| Group-2: Controls | – | –Type 2 Diabetes mellitus patients on full doses of vildagliptin+metformin+pioglitazone and on Insulin >0.4U/Kg who will act as active control.They will receive injectable placebo at Day 1 in addition to above and will be followed up for 6 months.Follow up investigation and Insulin dose titration will be similar to Group 1. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 2 Diabetes mellitus with triple Oral hypoglycemic failure and on Insulin for glycemic control
Key inclusion criteria (6 listed)
- Patients with type 2 diabetes mellitus between 30 and 70 years of age.
- Failure to triple OHA and on stable doses of insulin for atleast 3 months.
- On vildagliptin,pioglitazone and metformin for atleast 3 months along with Insulin to maintain euglycemia.
- HbA1c < 8.5%.
- Insulin requirement ≥0.4 IU/kg/d.
Key exclusion criteria (8 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 cholecystitis/ cholelitiasis/ cholecystectomy
- 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 transplantationAlso: Autologous Bone marrow derived stem cell transplantationGroup 1: 200 - 250 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - Hyperaque) and stem cells will be separated. Separated MNC's will be tagged with FDG-PET and injected into superior pancreatico duodenal artery and an PET scan will be done 2 hours later to see the percentage of stem cells homing in to pancreas. After 8 weeks G-CSF(10mcg/Kg/day) will be given subcutaneous for 5 days to achieve a Leucocyte count of >40,000/mm3. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide, plasma Insulin, HOMA-IR , HOMA-B ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months . | Biological | Group 1:Stem cell Recipient |
Primary outcome
Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels .
Time frame: 6 months
1 secondary outcome
Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2015.
- Results publication: PubMed 19686048Bhansali A, Upreti V, Khandelwal N, Marwaha N, Gupta V, Sachdeva N, Sharma RR, Saluja K, Dutta P, Walia R, Minz R, Bhadada S, Das S, Ramakrishnan S. Efficacy of autologous bone marrow-derived stem cell transplantation in patients with type 2 diabetes mellitus. Stem Cells Dev. 2009 Dec;18(10):1407-16. doi: 10.1089/scd.2009.0164.
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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, MD.,DM study chair
Post Graduate Institute of Medical Education and Research, Chandigarh
Neelam Marwaha, MD.,DM principal investigator
Post Graduate Institute of Medical Education and Research, Chandigarh
N Khandelwal, 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?
An observational study of 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 8 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: finished, as of the sponsor's last update on 21 Oct 2015. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels . (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01065298, which also lists 1 linked publication.
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 21 Oct 2015.