PMID- 37223507
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230525
IS  - 2352-3042 (Electronic)
IS  - 2352-4820 (Print)
IS  - 2352-3042 (Linking)
VI  - 10
IP  - 2
DP  - 2023 Mar
TI  - Phase I trial of human umbilical cord-derived mesenchymal stem cells for 
      treatment of severe bronchopulmonary dysplasia.
PG  - 521-530
LID - 10.1016/j.gendis.2022.02.001 [doi]
AB  - Severe bronchopulmonary dysplasia (BPD) is a chronic lung disorder that primarily 
      affects premature babies with extremely low birth weight and involves in multiple 
      organ system; no effective pharmacotherapy for this disease exists, and mortality 
      remains high. Based on the evidence from previous preclinical studies and phase I 
      clinical trials, this study aims to test the safety of intravenous application of 
      a single dose of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) 
      in patients with severe BPD. The Mesenchymal Stem cells for Bronchopulmonary 
      Dysplasia Treatment (MSBDT) trial is a single center, open-label, dose-escalation 
      phase I clinical trial. Severe BPD patients were enrolled in Children Hospital of 
      Chongqing Medical University, Chongqing, China. The first six patients were 
      treated with low-dose hUC-MSCs (1 x 10(6) cells/kg) and the next seven patients 
      were treated with high-dose hUC-MSCs (5 x 10(6) cells/kg). This study is 
      registered with ClinicalTrials.gov, number NCT03558334. No prespecified 
      infusion-associated adverse events, immediate complication, respiratory or 
      cardiovascular compromise were observed during infusion and 24 h after infusion. 
      No significant changes in safety laboratory values were observed. One death event 
      occurred in the low-dose group on study day 10, and one death event occurred in 
      the high-dose group on study day 24, while, after review in detail, the two cases 
      are not believed to be infusion-associated events. In conclusion, intravenous 
      application of a single dose of hUC-MSCs was tolerated in thirteen patients with 
      severe BPD.
CI  - (c) 2022 The Authors. Publishing services by Elsevier B.V. on behalf of KeAi 
      Communications Co., Ltd.
FAU - Xia, Yunqiu
AU  - Xia Y
AD  - Department of Dermatology, Ministry of Education Key Laboratory of Child 
      Development and Disorders, National Clinical Research Center for Child Health and 
      Disorders, China International Science and Technology Cooperation Base of Child 
      Development and Critical Disorders, Children's Hospital of Chongqing Medical 
      University, Chongqing 400014, China.
FAU - Lang, Tingyuan
AU  - Lang T
AD  - Department of Gynecologic Oncology, School of Medicine, Chongqing University 
      Cancer Hospital, Chongqing University, Chongqing 400030, China.
FAU - Niu, Yuqin
AU  - Niu Y
AD  - The First Affiliated Hospital, School of Medicine, Shihezi University, Shihezi, 
      Xinjiang 832008, China.
FAU - Wu, Xian
AU  - Wu X
AD  - Department of Respiratory Medicine, West China Second University Hospital, 
      Sichuan University, Chengdu, Sichuan 610041, China.
FAU - Zhou, Ou
AU  - Zhou O
AD  - Department of Respiratory Medicine, Children's Hospital of Chongqing Medical 
      University, Chongqing 400014, China.
FAU - Dai, Jihong
AU  - Dai J
AD  - Department of Respiratory Medicine, Children's Hospital of Chongqing Medical 
      University, Chongqing 400014, China.
FAU - Bao, Lei
AU  - Bao L
AD  - Department of Neonatology, Children's Hospital of Chongqing Medical University, 
      Chongqing 400014, China.
FAU - Yang, Ke
AU  - Yang K
AD  - Chongqing Engineering Technology Research Center of Stem Cell Therapy, Children's 
      Hospital of Chongqing Medical University, Chongqing 400014, China.
FAU - Zou, Lin
AU  - Zou L
AD  - Center for Clinical Molecular Medicine, Children's Hospital of Chongqing Medical 
      University, Chongqing 400014, China.
FAU - Fu, Zhou
AU  - Fu Z
AD  - Department of Respiratory Medicine, Children's Hospital of Chongqing Medical 
      University, Chongqing 400014, China.
AD  - Chongqing Engineering Technology Research Center of Stem Cell Therapy, Children's 
      Hospital of Chongqing Medical University, Chongqing 400014, China.
FAU - Geng, Gang
AU  - Geng G
AD  - Department of Respiratory Medicine, Children's Hospital of Chongqing Medical 
      University, Chongqing 400014, China.
LA  - eng
SI  - ClinicalTrials.gov/NCT03558334
PT  - Journal Article
DEP - 20220222
PL  - Netherlands
TA  - Genes Dis
JT  - Genes & diseases
JID - 101635967
PMC - PMC10201597
OTO - NOTNLM
OT  - Bronchopulmonary dysplasia
OT  - Dose escalation
OT  - Human umbilical cord-derived mesenchymal stem cells
OT  - Intravenous treatment
OT  - Phase I trial
COIS- All authors declare that there are no conflicts of interest related to the 
      contents of this article.
EDAT- 2022/02/22 00:00
MHDA- 2022/02/22 00:01
PMCR- 2022/02/22
CRDT- 2023/05/24 11:48
PHST- 2021/12/15 00:00 [received]
PHST- 2022/01/13 00:00 [revised]
PHST- 2022/02/01 00:00 [accepted]
PHST- 2022/02/22 00:01 [medline]
PHST- 2022/02/22 00:00 [pubmed]
PHST- 2023/05/24 11:48 [entrez]
PHST- 2022/02/22 00:00 [pmc-release]
AID - S2352-3042(22)00034-4 [pii]
AID - 10.1016/j.gendis.2022.02.001 [doi]
PST - epublish
SO  - Genes Dis. 2022 Feb 22;10(2):521-530. doi: 10.1016/j.gendis.2022.02.001. 
      eCollection 2023 Mar.