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Autologous bone marrow-derived mononuclear cells transplantation in type 2 diabetes mellitus: effect on β-cell
Shobhit Bhansali1, Pinaki Dutta1, Mukesh Kumar Yadav2
1Department of Endocrinology, Post Graduate Institute of Medical Education and Research, Sector-12, Chandigarh, 160012 India.
Background:
Insulin resistance and insulin deficiency are the cardinal defects in the pathogenesis of type 2 diabetes mellitus (T2DM). Despite the plethora of anti-diabetic medications, drugs specifically targeting the β-cells are still desired. Stem cell therapy has emerged as a novel therapeutics strategy to target β-cells; however, their mechanism of action has not been well defined. This study aims to examine the efficacy and safety of autologous bone marrow-derived mononuclear cells (ABM-MNCs) transplantation in T2DM, and explores the mechanistic insights into stem cells action through metabolic studies.
Methods:
Seven T2DM patients with the duration of disease ≥5 years, receiving triple oral anti-diabetic drugs along with insulin (≥0.4 IU per kg per day) and HbA1c ≤ 7.5% (≤58.0 mmol/mol) were enrolled for ABM-MNCs administration through a targeted approach. The primary end-point was a reduction in insulin requirement by ≥50% from baseline, while maintaining HbA1c < 7.0% (<53.0 mmol/mol) with improvement in insulin secretion, and/or insulin sensitivity after ABM-MNCs transplantation.
Results:
Six out of 7 (90%) patients achieved the primary end-point. At 6 months, there was a significant reduction in insulin requirement by 51% as compared to baseline (p < 0.003). This was accompanied by a significant increase in the 2nd phase C-peptide response during hyperglycemic clamp (p = 0.018), whereas there were no significant alterations in insulin sensitivity and glucose disposal rate during hyperinsulinemic-euglycemic clamp relative to the baseline. Other measures of β-cell indices like HOMA-β, and stimulated C-peptide response to glucagon and mixed meal tolerance test were non-contributory.
Conclusion:
ABM-MNCs transplantation results in significant reduction in insulin doses and improvement in C-peptide response in patients with T2DM. Metabolic studies may be more useful than conventional indices to predict β-cell function in patients with advanced duration of T2DM. Trial registration-Clinicaltrials.gov NCT01759823.
Insights
Autologous bone marrow-derived mononuclear cells (ABM-MNCs) transplantation significantly reduced insulin doses in type 2 diabetes mellitus (T2DM) patients. This stem cell therapy improved C-peptide response, indicating enhanced beta-cell function.
Area of Science:
- Endocrinology and Metabolism
- Regenerative Medicine
- Diabetes Research
Background:
- Type 2 diabetes mellitus (T2DM) is characterized by insulin resistance and deficiency.
- Current anti-diabetic medications have limitations, highlighting the need for beta-cell targeted therapies.
- Stem cell therapy offers a novel approach, but its mechanisms in T2DM require elucidation.
Purpose of the Study:
- To evaluate the efficacy and safety of autologous bone marrow-derived mononuclear cells (ABM-MNCs) transplantation in T2DM patients.
- To explore the mechanistic insights into stem cell action through metabolic studies in T2DM.
Main Methods:
- Seven T2DM patients with disease duration ≥5 years received ABM-MNCs transplantation.
- Patients were on triple oral anti-diabetic drugs and insulin (≥0.4 IU/kg/day) with HbA1c ≤7.5%.
- Primary endpoint: ≥50% reduction in insulin requirement while maintaining HbA1c <7.0% and improved insulin secretion/sensitivity.
Main Results:
- 90% of patients (6/7) achieved the primary endpoint.
- A significant 51% reduction in insulin requirement was observed at 6 months (p<0.003).
- Significant increase in 2nd phase C-peptide response (p=0.018); no significant changes in insulin sensitivity or glucose disposal rate.
Conclusions:
- ABM-MNCs transplantation effectively reduces insulin dosage in T2DM patients.
- The therapy improves C-peptide response, suggesting enhanced beta-cell function.
- Metabolic studies are more informative than conventional indices for assessing beta-cell function in advanced T2DM.
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