Authors:
Anil Bhansali, Premkumar A, Rama Walia, Shobhit Bhansali, Vivek Gupta, Ashish Jain, Naresh Sachdeva, R.R. Sharma, Neelam Marwaha, & Niranjan Khandelwal
Summary:
There is a growing interest in cell based therapies in T2DM as β-cell failure is progressive and inexorable with advancing duration of disease. This prospective, randomized, single blinded placebo-controlled study evaluates the efficacy and safety of autologous bone marrow derived stem cell transplantation (ABMSCT) in T2DM. Twenty one patients with triple oral anti-diabetic drugs failure and requiring insulin ≥0.4 IU per kg per day with HbA1c <7.5% were randomly assigned to intervention (n=11) and control arm (n=10) and followed for 12 months. Patients in intervention arm received ABMSCT through targeted approach following that after 12 weeks, a second dose of stem cells was administered through ante-cubital vein after mobilization with G-CSF, while control arm underwent sham procedure. The primary end point was a reduction in insulin requirement by ≥50% from baseline. Nine out of the 11(82%) patients in the intervention group achieved the primary end point with a mean HbA1c <7% in 89% of patients, while none in the control group over the study period. Insulin requirement decreased by 62% in the intervention arm from 47.7±6.2 IU per day to 18.0±6.7 IU per day, while in controls it decreased by 23.4% from 40.6±3.7 IU per day to 31.1±3.9 IU/day (p= 0.004) at 12 months. There was a modest increase in HbA1c (%) in cases from 6.8 to 6.9±0.2% (p=0.424) while it significantly increased in controls from 6.7 ± 0.2 to 7.2 ± 0.2% (p=0.044). The glucagon stimulated C-peptide significantlyincreasedincases as compared to controls (p=0.032). The decrease in insulin requirement positively correlated with stimulated C-peptide (r=0.8, p=0.001). In conclusion, ABMSCT results in significant decrease in the insulin dose requirement along with improvement in the stimulated C-peptide levels in T2DM. However, more number of patients with a longer duration of follow-up are required to substantiate these observations.
Source:
Cell Transplantation; (04/02/13)