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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified November 2009 by Postgraduate Institute of Medical Education and Research.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Postgraduate Institute of Medical Education and Research

ClinicalTrials.gov Identifier:

NCT01065298

First received: February 8, 2010

Last updated: February 10, 2010

Last verified: November 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

February 8, 2010

Last Updated Date

February 10, 2010

Start Date ^ICMJE

November 2009

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01065298 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients with type 2 Diabetes mellitus with triple Oral hypoglycemic failure and on Insulin for glycemic control

Condition ^ICMJE

Type 2 Diabetes Mellitus

Intervention ^ICMJE

Biological: 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 .

Other Name: Autologous Bone marrow derived stem cell transplantation

Study Group/Cohort (s)

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

Intervention: 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.

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2011

Estimated Primary Completion Date

July 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Gender

Both

Ages

30 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Anil Bhansali, MD.,DM	2756583 ext 0172	anilbhansali_endocrine@rediffmail.com
Contact: Prem kumar, MD	09872308780	prem.kkumar@rediffmail.com

Location Countries ^ICMJE

India

Administrative Information

NCT Number ^ICMJE

NCT01065298

Other Study ID Numbers ^ICMJE

ABMSCT2

Has Data Monitoring Committee

Yes

Responsible Party

Anil Bhansali, PIMERindia

Study Sponsor ^ICMJE

Postgraduate Institute of Medical Education and Research

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Anil Bhansali, MD.,DM	Postgraduate Institute of Medical Education and Research
Principal Investigator:	Neelam Marwaha, MD.,DM	Postgraduate Institute of Medical Education and Research
Principal Investigator:	N Khandelwal, MD	Postgraduate Institute of Medical Education and Research
Principal Investigator:	B.R. Mittal, MD	Postgraduate Institute of Medical Education and Research
Principal Investigator:	Prem Kumar, MD	Postgraduate Institute of Medical Education and Research
Principal Investigator:	Rama Walia, MD.,DM	Postgraduate Institute of Medical Education and Research

Information Provided By

Postgraduate Institute of Medical Education and Research

Verification Date

November 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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