PMID- 38219142 OWN - NLM STAT- MEDLINE DCOM- 20240226 LR - 20240226 IS - 1477-2566 (Electronic) IS - 1465-3249 (Linking) VI - 26 IP - 3 DP - 2024 Mar TI - Predictive factors that influence the clinical efficacy of umbilical cord-derived mesenchymal stromal cells in the treatment of type 2 diabetes mellitus. PG - 311-316 LID - S1465-3249(24)00002-1 [pii] LID - 10.1016/j.jcyt.2023.12.006 [doi] AB - BACKGROUND: Our previous single-center, randomized, double-blinded, placebo-controlled phase 2 study evaluated the safety and effectiveness of human umbilical cord mesenchymal stromal cell (UC-MSC) transfusion for treating patients with type 2 diabetes mellitus (T2DM). Indeed, this potential treatment strategy was able to reduce insulin use by half in a considerable number of patients. However, many other patients' responses to UC-MSC transfusion were insignificant. The selection of patients who might benefit from UC-MSC treatment is crucial from a clinical standpoint. METHODS: In this post hoc analysis, 37 patients who received UC-MSC transfusions were divided into two groups based on whether their glycated hemoglobin (hemoglobin A1c, or HbA1c) level was less than 7% after receiving UC-MSC treatment. The baseline differences between the two groups were summarized, and potential factors influencing efficacy of UC-MSCs for T2DM were analyzed by univariate and multivariate logistic regression. The correlations between the relevant hormone levels and the treatment effect were further analyzed. RESULTS: At the 9-week follow-up, 59.5% of patients achieved their targeted HbA1c level. Male patients with lower baseline HbA1c and greater C-peptide area under the curve (AUCC-pep) values responded favorably to UC-MSC transfusion, according to multivariate analysis. The effectiveness of UC-MSCs transfusion was predicted by AUCC-pep (cutoff value: 14.22 ng/h/mL). Further investigation revealed that AUCC-pep was increased in male patients with greater baseline testosterone levels. CONCLUSIONS: Male patients with T2DM with greater AUCC-pep may be more likely to respond clinically to UC-MSC therapy, and further large-scale multi-ethnic clinical studies should be performed to confirm the conclusion. CI - Copyright (c) 2024 International Society for Cell & Gene Therapy. Published by Elsevier Inc. All rights reserved. FAU - Wang, Yuepeng AU - Wang Y AD - Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China; School of Medicine, Nankai University, Tianjin, China. FAU - Chen, Haixu AU - Chen H AD - Institute of Geriatrics & National Clinical Research Center of Geriatrics Disease, The Second Medical Center of Chinese PLA General Hospital, Beijing, China. FAU - Li, Yijun AU - Li Y AD - Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China. FAU - Hao, Haojie AU - Hao H AD - Department of Biotherapy, The First Medical Center of Chinese PLA General Hospital, Beijing, China. FAU - Liu, Jiejie AU - Liu J AD - Department of Biotherapy, The First Medical Center of Chinese PLA General Hospital, Beijing, China. FAU - Chen, Yulong AU - Chen Y AD - Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China. FAU - Meng, Junhua AU - Meng J AD - Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China. FAU - Zhang, Saichun AU - Zhang S AD - Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China. FAU - Gu, Weijun AU - Gu W AD - Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China. FAU - Lyu, Zhaohui AU - Lyu Z AD - Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China. FAU - Zang, Li AU - Zang L AD - Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China. Electronic address: zangli301@163.com. FAU - Mu, Yiming AU - Mu Y AD - Department of Endocrinology, The First Medical Center of Chinese PLA General Hospital, Beijing, China. Electronic address: muyiming@301hospital.com.cn. LA - eng PT - Clinical Trial, Phase II PT - Journal Article PT - Randomized Controlled Trial DEP - 20240113 PL - England TA - Cytotherapy JT - Cytotherapy JID - 100895309 RN - 0 (Glycated Hemoglobin) SB - IM MH - Humans MH - Male MH - *Diabetes Mellitus, Type 2/therapy/metabolism MH - Glycated Hemoglobin MH - Umbilical Cord MH - Treatment Outcome MH - *Mesenchymal Stem Cells/physiology MH - *Mesenchymal Stem Cell Transplantation OTO - NOTNLM OT - C-peptide area under the curve OT - glycated hemoglobin OT - male OT - mesenchymal stromal cells OT - testosterone OT - type 2 diabetes mellitus COIS- Declaration of Competing Interest The authors have no commercial, proprietary or financial interest in the products or companies described in this article. EDAT- 2024/01/14 14:42 MHDA- 2024/02/26 06:43 CRDT- 2024/01/14 10:34 PHST- 2023/09/02 00:00 [received] PHST- 2023/11/20 00:00 [revised] PHST- 2023/12/26 00:00 [accepted] PHST- 2024/02/26 06:43 [medline] PHST- 2024/01/14 14:42 [pubmed] PHST- 2024/01/14 10:34 [entrez] AID - S1465-3249(24)00002-1 [pii] AID - 10.1016/j.jcyt.2023.12.006 [doi] PST - ppublish SO - Cytotherapy. 2024 Mar;26(3):311-316. doi: 10.1016/j.jcyt.2023.12.006. Epub 2024 Jan 13.