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

引用

Genes & Diseases 2023年第2期10卷 521-530页

作者： Yunqiu Xia Tingyuan Lang Yuqin Niu Xian Wu Ou Zhou Jihong Dai Lei Bao Ke Yang Lin Zou Zhou Fu Gang Geng Department of Dermatology Ministry of Education Key Laboratory of Child Development and DisordersNational Clinical Research Center for Child Health and DisordersChina International Science and Technology Cooperation Base of Child Development and Critical DisordersChildren's Hospital of Chongqing Medical UniversityChongqing 400014China Department of Gynecologic Oncology School of MedicineChongqing University Cancer HospitalChongqing UniversityChongqing 400030China The First Affiliated Hospital School of MedicineShihezi UniversityShiheziXinjiang 832008China Department of Respiratory Medicine West China Second University HospitalSichuan UniversityChengduSichuan 610041China Department of Respiratory Medicine Children's Hospital of Chongqing Medical UniversityChongqing 400014China Department of Neonatology Children's Hospital of Chongqing Medical UniversityChongqing 400014China Chongqing Engineering Technology Research Center of Stem Cell Therapy Children's Hospital of Chongqing Medical UniversityChongqing 400014China Center for Clinical Molecular Medicine Children's Hospital of Chongqing Medical UniversityChongqing 400014China

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^(6) cells/kg)and the next seven patients were treated with high-dose hUC-MSCs(5×10^(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.

关键词： Bronchopulmonary dysplasia Dose escalation Human umbilical cord-derived mesenchymal stem cells intravenous treatment Phase I trial

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