PMID- 35505375
OWN - NLM
STAT- MEDLINE
DCOM- 20220505
LR  - 20221207
IS  - 1757-6512 (Electronic)
IS  - 1757-6512 (Linking)
VI  - 13
IP  - 1
DP  - 2022 May 3
TI  - Efficacy and safety of umbilical cord-derived mesenchymal stem cells in Chinese 
      adults with type 2 diabetes: a single-center, double-blinded, randomized, 
      placebo-controlled phase II trial.
PG  - 180
LID - 10.1186/s13287-022-02848-6 [doi]
LID - 180
AB  - BACKGROUND: To determine the efficacy and safety of umbilical cord-derived 
      mesenchymal stem cells (UC-MSCs) in Chinese adults with type 2 diabetes mellitus 
      (T2DM). METHODS: In this single-center, double-blinded, randomized, 
      placebo-controlled phase II trial, 91 patients were randomly assigned to receive 
      intravenous infusion of UC-MSCs (n = 45) or placebo (n = 46) three times with 
      4-week intervals and followed up for 48 weeks from October 2015 to December 2018. 
      The primary endpoint was the percentage of patients with glycated hemoglobin 
      (HbA1c) levels of < 7.0% and daily insulin reduction of >/= 50% at 48 weeks. 
      Additional endpoints were changes of metabolic control, islet beta-cell function, 
      insulin resistance, and safety. RESULTS: At 48 weeks, 20% of the patients in the 
      UC-MSCs group and 4.55% in the placebo group reached the primary endpoint 
      (p < 0.05, 95% confidence interval (CI) 2.25-28.66%). The percentage of insulin 
      reduction of the UC-MSCs group was significantly higher than that of the placebo 
      group (27.78% versus 15.62%, p < 0.05). The levels of HbA1c decreased 1.31% 
      (9.02 +/- 1.27% to 7.52 +/- 1.07%, p < 0.01) in the UC-MSCs group, and only 0.63% in 
      the placebo group (8.89 +/- 1.11% to 8.19 +/- 1.02%, p>0.05; p = 0.0081 between both 
      groups). The glucose infusion rate (GIR) increased significantly in the UC-MSCs 
      group (from 3.12 to 4.76 mg/min/kg, p < 0.01), whereas no significant change was 
      observed in the placebo group (from 3.26 to 3.60 mg/min/kg, p > 0.05; p < 0.01 
      between both groups). There was no improvement in islet beta-cell function in both 
      groups. No major UC-MSCs transplantation-related adverse events occurred. 
      CONCLUSIONS: UC-MSCs transplantation could be a potential therapeutic approach 
      for Chinese adults with T2DM. Trial registration This study was registered on 
      ClinicalTrials.gov (identifier: NCT02302599).
CI  - (c) 2022. The Author(s).
FAU - Zang, Li
AU  - Zang L
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Li, Yijun
AU  - Li Y
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Hao, Haojie
AU  - Hao H
AD  - Department of Biotherapy, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Liu, Jiejie
AU  - Liu J
AD  - Department of Biotherapy, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Cheng, Yu
AU  - Cheng Y
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Li, Bing
AU  - Li B
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Yin, Yaqi
AU  - Yin Y
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Zhang, Qian
AU  - Zhang Q
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Gao, Fei
AU  - Gao F
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Wang, Haibin
AU  - Wang H
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Gu, Shi
AU  - Gu S
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Li, Jia
AU  - Li J
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Lin, Fengxiang
AU  - Lin F
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Zhu, Yingfei
AU  - Zhu Y
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Tian, Guanglei
AU  - Tian G
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Chen, Yulong
AU  - Chen Y
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Gu, Weijun
AU  - Gu W
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Du, Jin
AU  - Du J
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Chen, Kang
AU  - Chen K
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Guo, Qinghua
AU  - Guo Q
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Yang, Guoqing
AU  - Yang G
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Pei, Yu
AU  - Pei Y
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Yan, Wenhua
AU  - Yan W
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Wang, Xianling
AU  - Wang X
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Meng, Junhua
AU  - Meng J
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Zhang, Saichun
AU  - Zhang S
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Ba, Jianming
AU  - Ba J
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Lyu, Zhaohui
AU  - Lyu Z
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Dou, Jingtao
AU  - Dou J
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China.
FAU - Han, Weidong
AU  - Han W
AD  - Department of Biotherapy, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China. hanwdrsw69@yahoo.com.
FAU - Mu, Yiming
AU  - Mu Y
AUID- ORCID: 0000-0002-3344-3540
AD  - Department of Endocrinology, The First Medical Center of Chinese PLA General 
      Hospital, No. 28 Fuxing Road, Beijing, 100853, China. 
      muyiming@301hospital.com.cn.
LA  - eng
SI  - ClinicalTrials.gov/NCT02302599
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20220503
PL  - England
TA  - Stem Cell Res Ther
JT  - Stem cell research & therapy
JID - 101527581
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (Insulin)
SB  - IM
MH  - Adult
MH  - China
MH  - *Diabetes Mellitus, Type 2/therapy
MH  - Glycated Hemoglobin
MH  - Humans
MH  - Insulin
MH  - *Mesenchymal Stem Cells/physiology
MH  - Umbilical Cord
PMC - PMC9066971
OTO - NOTNLM
OT  - Glycated hemoglobin A1c
OT  - Insulin resistance
OT  - Islet beta-cell function
OT  - Type 2 diabetes mellitus
OT  - Umbilical cord-derived mesenchymal stem cells
COIS- The authors declare that they have no competing interests.
EDAT- 2022/05/04 06:00
MHDA- 2022/05/06 06:00
PMCR- 2022/05/03
CRDT- 2022/05/03 23:48
PHST- 2021/11/24 00:00 [received]
PHST- 2022/04/14 00:00 [accepted]
PHST- 2022/05/03 23:48 [entrez]
PHST- 2022/05/04 06:00 [pubmed]
PHST- 2022/05/06 06:00 [medline]
PHST- 2022/05/03 00:00 [pmc-release]
AID - 10.1186/s13287-022-02848-6 [pii]
AID - 2848 [pii]
AID - 10.1186/s13287-022-02848-6 [doi]
PST - epublish
SO  - Stem Cell Res Ther. 2022 May 3;13(1):180. doi: 10.1186/s13287-022-02848-6.