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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065298
• Other study ID #: ABMSCT2
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 8, 2010
• Last updated: October 19, 2015
• Start date: November 2009
• Est. completion date: July 2011

Study information

• Verified date: October 2015
• Source: Postgraduate Institute of Medical Education and Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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 .

Locations

Country	Name	City	State
India	Post Graduate Institute of Medical Education and Research	Chandigarh	Chandigarh UT

Sponsors (1)

Lead Sponsor	Collaborator
Postgraduate Institute of Medical Education and Research

Country where clinical trial is conducted

India, 

References & Publications (1)

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 mell — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of insulin requirement by = 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels .		6 months	No
Secondary	Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls.		6 months	No