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Therapeutic potential of human embryonic stem cells in type 2 diabetes mellitus.

ABSTRACT: To evaluate the safety and efficacy of human embryonic stem cells (hESCs) for the management of type 2 diabetes mellitus (T2DM).Patients with a previous history of diabetes and its associated complications were enrolled and injected with hESC lines as per the defined protocol. The patients were assessed using Nutech functional score (NFS), a numeric scoring scale to evaluate the patients for 11 diagnostic parameters. Patients were evaluated at baseline and at the end of treatment period 1 (T1). All the parameters were graded on the NFS scale from 1 to 5. Highest possible grade (HPG) of 5 was considered as the grade of best improvement.Overall, 94.8% of the patients showed improvement by at least one grade of NFS at the end of T1. For all the 11 parameters evaluated, 54% of patients achieved HPG after treatment. The four essential parameters (improvement in glycated hemoglobin (HbA1c) and insulin level, and fall in number of other oral hypoglycemic drugs with and without insulin) are presented in detail. For HbA1c, 72.6% of patients at the end of T1 met the World Health Organization cut off value, i.e., 6.5% of HbA1c. For insulin level, 65.9% of patients at the end of T1 were able to achieve HPG. After treatment, the improvement was seen in 16.3% of patients who required no more than two medications along with insulin. Similarly, 21.5% of patients were improved as their dosage regimen for using oral drugs was reduced to 1-2 from 5.hESC therapy is beneficial in patients with diabetes and helps in reducing their dependence on insulin and other medicines.

SUBMITTER: Shroff G

PROVIDER: S-EPMC4958687 | biostudies-other | 2016 Jul

REPOSITORIES: biostudies-other

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Therapeutic potential of human embryonic stem cells in type 2 diabetes mellitus.

Shroff Geeta G

World journal of stem cells 20160701 7

<h4>Aim</h4>To evaluate the safety and efficacy of human embryonic stem cells (hESCs) for the management of type 2 diabetes mellitus (T2DM).<h4>Methods</h4>Patients with a previous history of diabetes and its associated complications were enrolled and injected with hESC lines as per the defined protocol. The patients were assessed using Nutech functional score (NFS), a numeric scoring scale to evaluate the patients for 11 diagnostic parameters. Patients were evaluated at baseline and at the end ...[more]

PMID: 27468331

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Project description:BackgroundStem cell therapy provides great hope for patients with diabetes mellitus (DM). DM is a seriously alarming metabolic disease characterized by hyperglycemia and β cell dysfunction. Efficient novel therapeutic modalities to treat DM are indeed warranted. Stem cells (SC) derived from the umbilical cord specifically provide several advantages and unique characteristics being a readily available non-invasive source, with an additional credit for their banking potential. This meta-analysis study aims to provide a focused assessment for therapeutic efficacy of umbilical cord (UC)-derived SC-transplantation, namely Wharton's jelly mesenchymal stem cells (WJ-MSCs) and umbilical cord blood (UCB) for DM.MethodsThe clinical efficacy was evaluated based on glycemic control status (reflected on HbA1c%) and β cell function (reflected on C-peptide levels), as well as the daily insulin requirement in diabetic patients after receiving UC-derived SC-transplantation compared to baseline values. Moreover, we assessed these outcome measures in patients who received such intervention compared to those who did not receive it in randomized/non-randomized controlled clinical trials. We employed a random-effects model and standardized mean difference for this meta-analysis.ResultsEleven eligible clinical studies were included; WJ-MSCs (6 studies; 172 patients including 71 controls) and UCB (5 studies; 74 patients including 15 controls). WJ-MSCs significantly improved HbA1c% (pooled-estimate - 1.085; 95%CI (- 1.513, - 0.657); p < 0.001) and C-peptide levels (pooled-estimate 1.008; 95%CI (0.475, 1.541); p < 0.001), as well as the daily insulin-requirement (pooled-estimate - 2.027; 95%CI (- 3.32, - 0.733); p = 0.002). On the contrary, UCB was found to be uniformly ineffective; HbA1c% (pooled-estimate - 0.091, 95%CI (- 0.454, 0.271); p = 0.622), significantly deteriorated C-peptide levels (pooled-estimate - 0.789; 95%CI (- 1.252, - 0.325); p < 0.001) and daily insulin-requirement (pooled-estimate 0.916; 95%CI (0.247, 1.585); p = 0.007). All these observations remained consistent when we carried out sub-group meta-analysis for T1DM and T2DM and also when we compared patients who received WJ-MSCs or UCB to controls.ConclusionsThe results of our meta-analysis provide a clear evidence for the superior efficacy of WJ-MSCs over UCB in DM. This sheds lights on the importance to consider banking of WJ-MSCs together with the well-established routine UCB-banking, especially for those with family history of DM. Additionally, further clinical studies are required to investigate therapeutic efficacy of selected/enriched UCB-derived cell populations with immunomodulatory/regenerative potential in DM.

Dataset Information

Therapeutic potential of human embryonic stem cells in type 2 diabetes mellitus.

Publications

Therapeutic potential of human embryonic stem cells in type 2 diabetes mellitus.

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