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

Phase 1

• Conditions: Acute respiratory distress syndrome and/or profound septic shock complicated with multiple organ failure; Signs and Symptoms

• Registration Number: ISRCTN52319075
• Lead Sponsor: Chang Gung Memorial Hospital, Chang Gung Medical Foundation

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-08-23
• Last Update Posted: 22 January 2024
• Study Completion: 2027-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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)

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Severity of ARDS and septic shock, assessed using APACHE II score at baseline<br>2. Organ function, assessed daily using SOFA score once daily from enrollment and until freedom from critical condition<br>3. GCS level, PaO2/FiO2, vital signs, level of serum Cr, ALT, total bilirubin, PT, APTT, platelet count, CRP, and lactate, measured using blood sample once daily from starting treatment<br>4. In-hospital mortality and 30-day mortality<br>5. Immune function and cytokine level assessed at baseline, the first 3 days, and one week later

Secondary Outcome Measures

Name	Time	Method
Adverse events including immune response to stem cell therapy, hyperreactivity to HUCDMSC, anaphylactic shock, or incidental malignancy after cell-based therapy. After discharge, patients will be followed up regularly in the outpatient setting at 1 month and every 3 months. The total follow-up period is one year.