Regenerative Medicine, Advancells

4/6/2018

Long term safety and efficacy of autologous stem cell transplantation for the treatment of type 2 diabetes mellitus - ScienceDirect

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Cytotherapy Volume 19, Issue 5, Supplement, May 2017, Page S24

41 - Long term safety and efficacy of autologous stem cell transplantation for the treatment of type 2 diabetes mellitus L. Singh 1, V. Jain 1, P. Sharma 2, 1, S. Singh 1, S. Ramesh 1, R. Maurya 1, S.K. Raghav 1 1

Regenerative Medicine, Advancells, Noida, Uttar Pradesh, India

2

General Medicine, Institute of Brain and spine Hospital, New Delhi, India

Available online 1 May 2017.

https://doi.org/10.1016/j.jcyt.2017.02.045

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Background: Autologous stem cell therapies are emerging set of therapies which help in regeneration and differentiation of β-cells with promising outcomes and very low incidence of adverse effects. The aim of the study is to assess the safety and efficacy of selective intraarterial Autologous stem cells (ASCs) infusion in metabolic control with reduction in HbA1c and improvement in β-cell function (c-peptide), contributing to the reduction of OHA and insulin requirements.

Methods and Materials: Twenty patients (14 males & 06 females; aged 35 years to 62 years) were enrolled from October 2014 to November 2016 with Type 2 DM for 5–6 years duration, underwent catheter based target delivery of ASCs. Clinical variables (BMI, duration of diabetes,

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4/6/2018

Long term safety and efficacy of autologous stem cell transplantation for the treatment of type 2 diabetes mellitus - ScienceDirect

insulin requirement, OHA, duration free of insulin/oral drugs), and laboratory variables (FPG, FPI, C- peptide, HbA1C, HOMA-IR & HOMA-B) were evaluated over a period starting at baseline and up to 24 months follow up post infusion. The primary outcome measures were reduction of insulin requirement by ≥50% by the end of 3 months and the improvement in Cpeptide levels. Secondary endpoints were turned down in insulin dosage and HbA1C, at 24 months. Follow- ups were done in the 30, 90,180,360, 540 and 720 days. Baseline variables expressed as Mean ± SEs. Results: Sixteen patients (80%) demonstrated a decrease in insulin requirement of 60% to 75% in 3 to 6 months. Four patients (20%) discontinued insulin and maintained on diet and exercise. There was a significant improvement in c- peptide levels in the group (p ≤ 0.005) and responders (p ≤ 0.005) in 6 months. The mean HbA1c reduction was 1% to 2.4 % in 45 days to 6 months. Four responders had HbA1C value ≤7 %. HOMA-B increased significantly in the group (p ≤ 0.05) and responders (p ≤ 0.05). FPG reduced significantly (p ≤ 0.05) while FPI increased nonsignificantly (p ≤ 0.059) over 24 months.

Conclusion: ASCs infusion results in a significant decrease (60%–75%) in insulin requirements and HBA1C level (2.4%) and increased C-peptide levels (1.9–3.5 ± 0.16) ng/ml over a period of 3 months to 6 months. The safety and efficacy of ASCs infusion were maintained over a period of 24 months without any severe adverse effects. However, randomized controlled clinical trials will be required to authenticate our findings and the mechanism needs to be illustrated.

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