Ignite Creation Date:
2024-05-05 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 9:46 AM
Study NCT ID:
NCT00644241
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2008-03-20
Brief Title:
Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus
Sponsor:
Post Graduate Institute of Medical Education and Research Chandigarh
Organization:
PIMERIndia
Study Overview
Official Title:
Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SCT
Brief Summary:
India is the Diabetes Capital of the World with 41 million Indians having diabetes ie 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 eg 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 mice78910 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 07 U kg body weightday 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
1 Abolition or reduction of insulin requirement by 50 by the end of 6 months of ABMSCT
2 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
1 Any reduction in requirement of insulin dosage
2 Improvement of HbA1c levels as compared to baseline
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 mice78910 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 07 U kg body weightday 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
1 Abolition or reduction of insulin requirement by 50 by the end of 6 months of ABMSCT
2 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
1 Any reduction in requirement of insulin dosage
2 Improvement of HbA1c levels as compared to baseline
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None