Type 2 Diabetes MellitusPhase 2SCTNCT00644241
Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus
A Phase 2 study testing stem cell harvest and angiographic transplantation of stem cells 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
India is the "Diabetes Capital of the World" with 41 million Indians having diabetes i.e. every fifth diabetic in the world is an Indian1. Type 2 Diabetes Mellitus (T2DM) constitutes the major chunk of diabetes and has insulin resistance as the hallmark feature in the pathogenesis. 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 harvest and angiographic transplantation of stem cells
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2008to Jun 2009
- Phase
- Phase 2
- 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
Who may be able to join
- Patients with type 2 diabetes mellitus more than 30 and less than 75 years of age.
- Insulin requirement 0.7 IU/kg/d or 50 IU/d, whichever is lesser.
- 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 myocardial infarction or unstable angina in the previous 3 months.
- History of malignancy or current malignancy other than non-melanomatous skin cancer.
- Patients with active infections
Trial locations and contacts
1 site in 1 country.
About this study
India is the "Diabetes Capital of the World" with 41 million Indians having diabetes i.e. every fifth diabetic in the world is an Indian1. Type 2 Diabetes Mellitus (T2DM) constitutes the major chunk of diabetes and has insulin resistance as the hallmark feature in the pathogenesis. However, with the progression of the disease the insulin resistance becomes stable whereas β - cell function shows a gradual decline due to its ongoing apoptosis2. This ultimately leads to inability of the β - cells to cope up with the increased demand of insulin caused due to insulin resistance and manifests as hyperglycemia. As β - cell failure is progressive and inexorable, as demonstrated in United Kingdom Prospective Diabetes Study3, most of the patients with T2DM would eventually require insulin and it would be difficult to achieve to attain a strict glycemic control . It is well known that diabetes related complications which account for morbidity and mortality in this disease can be prevented or delayed by strict glycemic control. However, even with intensive insulin therapy it has been shown that glycemic control can never be perfect with patients exhibiting hyperglycemia or hypoglycemia during 24 hour glucose profile4. Also insulin therapy is not physiological as there is no hepatic "first - pass" metabolism of insulin which is required for halting the hepatic glucose output, which is responsible for fasting hyperglycemia5. This led the researchers to evolve various strategies of β - cell replacement therapy e.g. pancreatic transplantation and islet cell transplantation. Initially the results of islet cell transplantation were dismal but after the induction of glucocorticoid free immunosuppressive therapy and the use of adequate number of islet cells from multiple donors, the results of islet cell transplantation have been better6. However, islet cell transplantation has its own limitations viz insufficient supply, being technically demanding and requirement of lifelong immunosuppressive therapy in the recipient.
These shortcomings can be overcome by the use of stem cells which is an inexhaustible source of β -cells. Stem cells are primitive cells capable of differentiating into mature cells of the body of various lineages. Stem cells can be obtained from various sources like blastocyst (embryonal stem cells), umbilical cord or bone marrow. There is an evidence to suggest that stem cell transplantation can lead to improvement in pancreatic endocrine function and improvement in glycemic control in diabetic mice7,8,9,10 through various mechanisms such as transdifferentiation or regeneration of endothelial cell in the damaged islets which in turn lead to regeneration of islet cells by paracrine action11. However, till date there is no study that demonstrates that stem cell therapy can be effective in patients with T2DM for their glycemic control.
Read more
The investigators propose to carry out autologous bone marrow - derived stem cell transplantation (ABMSCT) in patients of T2DM, obtained from their own bone marrow and its superselective injection into the gastroduodenal artery after purification without any immunosuppressive regimen.
Aim:
The aim of this study is to reverse hyperglycemia and insulin dependency by ABMSCT in patients with type 2 diabetes mellitus.
Hypothesis:
The investigators hypothesize that ABMSCT into the pancreas of patients with T2DM, aged more than 30 years with insulin requirement of 0.7 U/ kg body weight/day or 50 U / day whichever is lesser, 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 will lead these patients to regenerate functional β - cells by transdifferentiation or by regeneration of endothelial cell which in turn cause β - cells neogenesis by paracrine effect.
Objectives:
Primary objective:
- Abolition or reduction of insulin requirement by > 50% by the end of 6 months of ABMSCT.
- To evaluate the increment of Glucagon stimulated C - peptide response at the end of 6 months of ABMSCT, as compared to the baseline values.
Secondary objective:
- Any reduction in requirement of insulin dosage.
- Improvement of HbA1c levels as compared to baseline.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- stem cell harvest, angiographic transplantation of stem cells
- Keywords
- stem cell therapy, T2DM, Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus
- 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 harvestBiological
stem cells will be harvested from the iliac crest of the patients
angiographic transplantation of stem cellsProcedure or surgery
autologous bone marrow derived stem cells will be transplanted in the gastroduodenal artery of the patient angiographically
| Study group | Role | What they receive |
|---|---|---|
| stem cell | Experimental | Not described Receives: Biological: stem cell harvest; Procedure: angiographic transplantation of stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abolition or reduction of insulin requirement by > 50% by the end of 6 months of ABMSCT
Measured: 6 months
Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline
Measured: 6 months
Secondary outcomes (2)
Any reduction in requirement of insulin dosage
Measured: 6 months
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 posted26 Mar 2008 (estimated)
- Study startJan 2008
- Primary completionJun 2009
- Study completionJun 2009
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00644241
- Sponsor's protocol ID
- SCT
- Acronym
- SCT
- Status last verified
- Oct 2015
- First submitted
- 20 Mar 2008
- Last updated
- 21 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
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
- NCT00644241
- Acronym / sponsor ID
- SCT / SCT
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- stem cell therapy, T2DM, Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 26 Mar 2008 (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.
India is the "Diabetes Capital of the World" with 41 million Indians having diabetes i.e. every fifth diabetic in the world is an Indian1. Type 2 Diabetes Mellitus (T2DM) constitutes the major chunk of diabetes and has insulin resistance as the hallmark feature in the pathogenesis. However, with the progression of the disease the insulin resistance becomes stable whereas β - cell function shows a gradual decline due to its ongoing apoptosis2. This ultimately leads to inability of the β - cells to cope up with the increased demand of insulin caused due to insulin resistance and manifests as hyperglycemia. As β - cell failure is progressive and inexorable, as demonstrated in United Kingdom Prospective Diabetes Study3, most of the patients with T2DM would eventually require insulin and it would be difficult to achieve to attain a strict glycemic control . It is well known that diabetes related complications which account for morbidity and mortality in this disease can be prevented or delayed by strict glycemic control. However, even with intensive insulin therapy it has been shown that glycemic control can never be perfect with patients exhibiting hyperglycemia or hypoglycemia during 24 hour glucose profile4. Also insulin therapy is not physiological as there is no hepatic "first - pass" metabolism of insulin which is required for halting the hepatic glucose output, which is responsible for fasting hyperglycemia5. This led the researchers to evolve various strategies of β - cell replacement therapy e.g. pancreatic transplantation and islet cell transplantation. Initially the results of islet cell transplantation were dismal but after the induction of glucocorticoid free immunosuppressive therapy and the use of adequate number of islet cells from multiple donors, the results of islet cell transplantation have been better6. However, islet cell transplantation has its own limitations viz insufficient supply, being technically demanding and requirement of lifelong immunosuppressive therapy in the recipient.
These shortcomings can be overcome by the use of stem cells which is an inexhaustible source of β -cells. Stem cells are primitive cells capable of differentiating into mature cells of the body of various lineages. Stem cells can be obtained from various sources like blastocyst (embryonal stem cells), umbilical cord or bone marrow. There is an evidence to suggest that stem cell transplantation can lead to improvement in pancreatic endocrine function and improvement in glycemic control in diabetic mice7,8,9,10 through various mechanisms such as transdifferentiation or regeneration of endothelial cell in the damaged islets which in turn lead to regeneration of islet cells by paracrine action11. However, till date there is no study that demonstrates that stem cell therapy can be effective in patients with T2DM for their glycemic control.
The investigators propose to carry out autologous bone marrow - derived stem cell transplantation (ABMSCT) in patients of T2DM, obtained from their own bone marrow and its superselective injection into the gastroduodenal artery after purification without any immunosuppressive regimen.
Aim:
The aim of this study is to reverse hyperglycemia and insulin dependency by ABMSCT in patients with type 2 diabetes mellitus.
Hypothesis:
The investigators hypothesize that ABMSCT into the pancreas of patients with T2DM, aged more than 30 years with insulin requirement of 0.7 U/ kg body weight/day or 50 U / day whichever is lesser, 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 will lead these patients to regenerate functional β - cells by transdifferentiation or by regeneration of endothelial cell which in turn cause β - cells neogenesis by paracrine effect.
Objectives:
Primary objective:
- Abolition or reduction of insulin requirement by > 50% by the end of 6 months of ABMSCT.
- To evaluate the increment of Glucagon stimulated C - peptide response at the end of 6 months of ABMSCT, as compared to the baseline values.
Secondary objective:
- Any reduction in requirement of insulin dosage.
- Improvement of HbA1c levels as compared to baseline.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stem cell | Experimental | Biological: stem cell harvest, Procedure: angiographic transplantation of stem cells |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with type 2 diabetes mellitus more than 30 and less than 75 years of age.
- Insulin requirement 0.7 IU/kg/d or 50 IU/d, whichever is lesser.
- GAD antibody negative status.
Key exclusion criteria (6 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 myocardial infarction or unstable angina in the previous 3 months.
- History of malignancy or current malignancy other than non-melanomatous skin cancer.
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 harveststem cells will be harvested from the iliac crest of the patients | Biological | stem cell |
| angiographic transplantation of stem cellsautologous bone marrow derived stem cells will be transplanted in the gastroduodenal artery of the patient angiographically | Procedure or surgery | stem cell |
Primary outcome
Abolition or reduction of insulin requirement by > 50% by the end of 6 months of ABMSCT
Time frame: 6 months
Increment in glucagon stimulated C - peptide levels at the end of 6 months of ABMSCT, as compared to baseline
Time frame: 6 months
2 secondary outcomes
Any reduction in requirement of insulin dosage
Time frame: 6 months
Improvement of HbA1c levels as compared to baseline
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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing stem cell harvest and angiographic transplantation of stem cells 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 3 inclusion and 6 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.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Abolition or reduction of insulin requirement by > 50% by the end of 6 months of ABMSCT (time frame: 6 months). The study lists 2 primary outcomes in all. 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 21 Oct 2015.