Phase I trial of human umbilical cord-derived mesenchymal stem cells for treatment of severe bronchopulmonary dysplasia

Yunqiu Xia; Tingyuan Lang; Yuqin Niu; Xian Wu; Ou Zhou; Jihong Dai; Lei Bao; Ke Yang; Lin Zou; Zhou Fu; Gang Geng

doi:10.1016/j.gendis.2022.02.001

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Phase I trial of human umbilical cord-derived mesenchymal stem cells for treatment of severe bronchopulmonary dysplasia

更新时间：2023-05-16

- Phase I trial of human umbilical cord-derived mesenchymal stem cells for treatment of severe bronchopulmonary dysplasia
- Genes & Diseases Vol. 10, Issue 2, (2023)
- 作者机构：
  
  1. Department of Respiratory Medicine, Children's Hospital of Chongqing Medical University,Chongqing,China,400014
  2. Chongqing Engineering Technology Research Center of Stem Cell Therapy, Children's Hospital of Chongqing Medical University,Chongqing,China,400014
  3. The First Affiliated Hospital, School of Medicine, Shihezi University,Xinjiang,Shihezi,China,832008
  4. 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,China,400014
  5. Department of Respiratory Medicine, West China Second University Hospital, Sichuan University,Sichuan,Chengdu,China,610041
  6. Department of Neonatology, Children's Hospital of Chongqing Medical University,Chongqing,China,400014
  7. Department of Gynecologic Oncology, School of Medicine, Chongqing University Cancer Hospital, Chongqing University,Chongqing,China,400030
  8. Center for Clinical Molecular Medicine, Children's Hospital of Chongqing Medical University,Chongqing,China,400014
- 作者简介：
- 基金信息：
- DOI：10.1016/j.gendis.2022.02.001
  CLC：
- Published：2023，
  
  Published Online：1 March 2023，
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Yunqiu Xia, Tingyuan Lang, Yuqin Niu, et al. Phase I trial of human umbilical cord-derived mesenchymal stem cells for treatment of severe bronchopulmonary dysplasia. [J]. Genes & Diseases 10(2).(2023)
DOI：

Yunqiu Xia, Tingyuan Lang, Yuqin Niu, et al. Phase I trial of human umbilical cord-derived mesenchymal stem cells for treatment of severe bronchopulmonary dysplasia. [J]. Genes & Diseases 10(2).(2023) DOI： 10.1016/j.gendis.2022.02.001.

摘要

Abstract

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 × 10

cells/kg) and the next seven patients were treated with high-dose hUC-MSCs (5 × 10

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.

关键词

Keywords

Bronchopulmonary dysplasiaDose escalationHuman umbilical cord-derived mesenchymal stem cellsIntravenous treatmentPhase I trial

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