Endocrine Abstracts

Introduction: There is a growing interest in cell-based therapies in T2DM as β-cell failure is progressive and inexorable. This study evaluates the efficacy of autologous bone marrow-derived mesenchymal stem cell transplantation (ABM-MSCT) in T2DM.

Methods: This prospective, randomised, single-blinded placebo-controlled study enrolled 20 patients with triple oral hypoglycaemic drug failure and requiring insulin ≥0.4 Units/kg per day for achieving euglycaemia (HbA1c ≤7.5%). They were randomly assigned to mesenchymal stem cells (MSCs) group (n=10) who received ABM-MSCT through targeted approach, while control arm (n=10) underwent sham procedure and were followed for 6 months. The efficacy of intervention was assessed by gold standard method ‘hyperglycaemic clamp’ to estimate C-peptide response. The primary endpoint was a reduction in insulin requirement by 50% from baseline, while maintaining HbA1c ≤7%.

Results: Six out of the 10 (60%) patients in the ABM-MSCT, while 1 (10%) in the control group achieved the primary endpoint (P=0.05). The insulin requirement decreased by 45% in the ABM-MSCT group from 45.5 (34.0–52.2) IU/day to 25 (15.0–32.5) IU/day (P=0.0001), while in controls it decreased by 4% from 52.0 (40.0–82.0) IU/day to 50 (22.0–58.0) IU/day (P=0.001) with significant reduction between both the groups at 6 months (P=0.047). There was a modest but significant decrease in HbA1c in cases from 6.9% (6.6–7.0%) to 6.8% (6.1–7.2%) (P=0.001) as well as in controls from 6.6% (6.1–6.8%) to 6.2% (6.0–6.2%) (P=0.001), but it was not significant between the groups (P=0.32). There was a significant decrease in 2nd phase C- peptide response during hyperglycaemic clamp (P=0.004) and HOMA-β (0.04) without any significant change in HOMA-IR (P=0.08).

Conclusion: The ABM-MSCT results in decrease in insulin requirement while maintaining HbA1c ≤7%. However, the mechanism/s related to improvement in glycaemia remains elusive.