Application of human umbilical cord-derived mesenchymal stem cells for patients with severe acute respiratory distress syndrome and/or profound septic shock complicated with multiple organ failure: a phase I clinical trial for evaluation of safety and tolerability

Chang Gung Memorial Hospital, Chang Gung Medical Foundation0 个研究点目标入组 20 人开始时间: 2017年8月23日最近更新: 2024年1月22日

适应症

试验速览

2020 Interim results article in https://pubmed.ncbi.nlm.nih.gov/32187077/ ARDS patients (added 21/05/2021)

•1. Adult subjects aged 20-80 years with severe ARDS or profound septic shock complicated with multiple organ failure due to infection
•2. Symptoms do not improve 5 days after traditional or standard therapy
•3. Severe acute respiratory distress syndrome defined as acute onset, bilateral infiltration on chest X-ray, pulmonary wedge pressure =18 mmHg, and PaO2/FiO2 =200 mmHg
•4. The definition of profound septic shock complicated with multiple organ failure was systolic blood pressure <90 mmHg with tissue hypoperfusion, combined with at least two organs failure (brain, lung, kidney, liver, or coagulation)

•1. Age <20 or >80 years
•2. Pregnant women
•3. Malignancy
•4. Autoimmune disease
•5. Subjects not suitable for enrollment due to any reason evaluated by investigator
•6. Patients who have joined other studies

发起方

Chang Gung Memorial Hospital, Chang Gung Medical Foundation