Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2

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

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-07-31

Brief Summary

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The purpose of this study is to improve blood glucose control in Type 2 Diabetes mellitus patients.

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Detailed Description

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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

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

stem cell transplantation

Intervention Type BIOLOGICAL

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 .

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.

No interventions assigned to this group

Interventions

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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 .

Intervention Type BIOLOGICAL

Other Intervention Names

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Autologous Bone marrow derived stem cell transplantation

Eligibility Criteria

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Inclusion Criteria

1. Patients with type 2 diabetes mellitus between 30 and 70 years of age.
2. Failure to triple OHA and on stable doses of insulin for atleast 3 months.
3. On vildagliptin,pioglitazone and metformin for atleast 3 months along with Insulin to maintain euglycemia.
4. HbA1c \< 8.5%.
5. Insulin requirement ≥0.4 IU/kg/d.
6. GAD antibody negative status.

Exclusion Criteria

1. Patients with T1DM or secondary diabetes.
2. Patients with serum creatinine \> 1.5 mg/dl.
3. 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).
4. History of cholecystitis/ cholelitiasis/ cholecystectomy
5. Seropositivity for HIV, HBsAg and HCV.
6. History of myocardial infarction or unstable angina in the previous 3 months.
7. History of malignancy
8. Patients with active infections.

Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Anil Bhansali

head of department

Responsibility Role PRINCIPAL_INVESTIGATOR