Clinical Trials Study
Copyright ©The Author(s) 2016. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Stem Cells. Jul 26, 2016; 8(7): 223-230
Published online Jul 26, 2016. doi: 10.4252/wjsc.v8.i7.223
Therapeutic potential of human embryonic stem cells in type 2 diabetes mellitus
Geeta Shroff
Geeta Shroff, Nutech Mediworld, New Delhi 110016, India
Author contributions: Shroff G conceptualized the study, participated in its design and coordination and drafted the manuscript; Shroff G read and approved the final manuscript; Shroff G contributed to study design and data analysis of the manuscript.
Institutional review board statement: The study was reviewed and approved by the Institutional Review Board of Nutech Mediworld, New Delhi, India.
Clinical trial registration statement: Not applicable.
Informed consent statement: All study participants, or their legal guardian, provided informed written consent prior to study enrollment.
Conflict-of-interest statement: The author declares no conflict of interest regarding the publication of this paper.
Data sharing statement: Not applicable.
Open-Access: This article is an open-access article which was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/
Correspondence to: Dr. Geeta Shroff, Director, Nutech Mediworld, H-8, Green Park Extension, New Delhi 110016, India. geetashroff@hotmail.com
Telephone: +91-11-26565548 Fax: +91-11-46067841
Received: March 22, 2016
Peer-review started: March 23, 2016
First decision: April 15, 2016
Revised: May 6, 2016
Accepted: May 31, 2016
Article in press: June 2, 2016
Published online: July 26, 2016
Abstract

AIM: To evaluate the safety and efficacy of human embryonic stem cells (hESCs) for the management of type 2 diabetes mellitus (T2DM).

METHODS: 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.

RESULTS: 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.

CONCLUSION: hESC therapy is beneficial in patients with diabetes and helps in reducing their dependence on insulin and other medicines.

Keywords: Type 2 diabetes mellitus, Human embryonic stem cells, Insulin, Glycated hemoglobin, Nutech functional scoring scale

Core tip: We began research on human embryonic stem cell (hESC) therapy in 1999. Today, we have used it in > 1400 patients, and have got patent for our technology in 65 countries including the United States. This study focused on the safety and efficacy of hESCs in patients who were chronically affected with 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) (another invention of Nutech Mediworld), a numeric scoring scale to evaluate the patients for 11 diagnostic parameters. 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. Patients were evaluated at baseline and at the end of treatment period 1 (T1). 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. Important parameters like glycated hemoglobin, insulin and use of oral hypoglycemic drugs with and without use of insulin were measured and their results have been presented in detail. It has been concluded from the study that hESC therapy is beneficial in patients with diabetes and helps in reducing their dependence on insulin and other conventional medicines. Their remarkable properties of reducing risk of immune mediated rejections and absence of hypoglycemic episodes while treating T2DM patients favor their use in management of T2DM.