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

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

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN52319075

Enrollment

Registered

2017-08-23

Start date

2017-07-27

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

The eligible subjects who are willing to receive intravenous therapy with human umbilical cord-derived mesenchymal stem cells for ARDS and profound septic shock complicated with multiple organ failure

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria: 1. Age 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

Design outcomes

Primary

Measure	Time frame
1. Severity of ARDS and septic shock, assessed using APACHE II score at baseline 2. Organ function, assessed daily using SOFA score once daily from enrollment and until freedom from critical condition 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 4. In-hospital mortality and 30-day mortality 5. Immune function and cytokine level assessed at baseline, the first 3 days, and one week later	—

Measure

Time frame

1. Severity of ARDS and septic shock, assessed using APACHE II score at baseline 2. Organ function, assessed daily using SOFA score once daily from enrollment and until freedom from critical condition 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 4. In-hospital mortality and 30-day mortality 5. Immune function and cytokine level assessed at baseline, the first 3 days, and one week later

—

Secondary

Measure	Time frame
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.	—

Countries

Taiwan

Contacts

Public ContactHon-Kan Yip

han.gung@msa.hinet.net+886 (0)7 731 7123 ext. 8300

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026