Clinical trial NCT01065298: Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus-2
Official title: Efficacy Of Autologous Bone Marrow Derived Stem Cell Transplantation In Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: PIMERIndia
Sponsor class: UNKNOWN
First posted: 2010-02-09
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 Diabetes mellitus with triple Oral hypoglycemic failure and on Insulin for glycemic control

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of insulin requirement by ≥ 50% by the end of 6 months of ABMSCT and Improvement in Glucagon stimulated C - peptide levels .
timeFrame: 6 months
Secondary outcomes:
measure: Any reduction in requirement of insulin dosage and any improvement of HbA1c levels as compared to controls.
timeFrame: 6 months
Other outcomes:
Locations:
city: Chandigarh
country: India
facility: Post Graduate Institute of Medical Education and Research
state: Chandigarh UT
Study officials:
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Anil Bhansali, MD.,DM
role: STUDY_CHAIR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Neelam Marwaha, MD.,DM
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: N Khandelwal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: B.R. Mittal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Prem Kumar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Post Graduate Institute of Medical Education and Research, Chandigarh
name: Rama Walia, MD.,DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1089/scd.2009.0164.