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Int J Stem Cells. 2019 Jul 31;12(2):195-205. doi: 10.15283/ijsc18076.

Efficacies of Stem Cell Therapies for Functional Improvement of the β Cell in Patients with Diabetes: A Systematic Review of Controlled Clinical Trials.

Author information

1
The Catholic University of Korea, Catholic Medical Center, Seoul, Korea.
2
Department of Preventive Medicine, College of Medicine, The Catholic University of Korea, Seoul, Korea.
3
Cell and Gene Therapy Products Division, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, Korea.
4
Division of Endocrinology and Metabolism, Department of Internal Medicine, Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea.
5
Medical Library, The Catholic University of Korea, Seoul, Korea.
6
Catholic High-Performance Cell Therapy Center & Department of Medical Life Science, College of Medicine, The Catholic University of Korea, Seoul, Korea.

Abstract

Background and Objectives:

This study was performed to investigate whether stem cell therapy enhances β cell function by meta-analysis with proper consideration of variability of outcome measurements in controlled trial of type 1 diabetes mellitus (T1DM) and type 2 diabetes mellitus (T2DM) patients.

Methods:

A systematic search was performed from inception to January 2018 in PubMed, EMBASE, and Cochrane databases. β cell function was assessed by stimulated C-peptide, fasting C-peptide, normal glycosylated hemoglobin levels (HbA1C), and exogenous insulin dose patterns. The quality of the studies were assessed by both the Cochrane Collaboration's Risk of Bias (ROB) for Randomized controlled trials and the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) for non-randomized controlled trials.

Results:

From the selected final 15 articles, total of 16 trials were analyzed. There were 6 T1DM trials (total 153 cases) and 10 T2DM trials (total 457 cases). In T2DM patients, the changes in stimulated C-peptide, HbA1c, and exogenous insulin dose versus baseline showed a favorable pattern with a significant heterogeneity in stem cell therapy. In T1DM, there was no significant difference between control group and stem cell therapy group in three indicators except for HbA1c. Most of the studies were rated as having high risk of bias in the quality assessment.

Conclusions:

The stem cell therapy for DM patients is not effective in T1DM but seems to be effective in improving the β cell function in T2DM. However the observed effect should be interpreted with caution due to the significant heterogeneity and high risk of bias within the studies. Further verification through a rigorously designed study is warranted.

KEYWORDS:

C-peptide; Diabetes mellitus; Stem cell; β cell

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