Human stem cell therapy for acute respiratory distress syndrome

Application of human umbilical cord-derived mesenchymal stem cells for moderate to severe acute respiratory distress syndrome: a randomized phase II clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN47911040

Enrollment

Registered

2021-10-26

Start date

2020-04-16

Completion date

Unknown

Last updated

2025-01-28

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

Conditions

Moderate to severe acute respiratory distress syndrome Respiratory

Interventions

Randomization process The study sequence will be generated by a computerized random number generator and preserved in a sealed envelope. The envelopes will be opened in consecutive order for enrollmen

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult subjects aged 20-80 years with moderate to severe ARDS, defined as: 1.1. Acute onset 1.2. Bilateral infiltration on chest X-ray 1.3. Pulmonary wedge pressure =18 mmHg 1.4. PaO2/FiO2 =200 mmHg 1.5. PEEP =10 cm H2O 2. Symptoms don’t improve 5 days after traditional or standard therapy

Exclusion criteria

Exclusion criteria: 1. Age 80 years 2. Pregnancy, breastfeeding 3. Malignancy 4. Autoimmune disease 5. Subjects not suitable for enrollment due to any reason evaluated by the investigator, or patients who have joined other studies

Design outcomes

Primary

Measure	Time frame
The in-hospital mortality and 30-day mortality recorded according to medical charts	—

Secondary

Measure	Time frame
1. Severity of ARDS measured using APCHE II (Acute Physiology and Chronic Health Evaluation) score during hospitalization 2. Organ function assessed using Sequential Organ Failure Assessment (SOFA) with parameters of GCS level, PaO2/FiO2, vital signs, level of serum creatinine, alanine aminotransferase (ALT), total bilirubin, prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet count, C-reactive protein (CRP), and lactate at baseline (pre-infusion), day 1, 3, 7 post-infusion, and 1-month post-infusion 3. Adverse events of stem cell transplantation including immune response, hyperreactivity, anaphylactic shock, incidental malignancy recorded using pulmonary X-ray or other imaging systems at 12 months post-infusion	—

Measure

Time frame

1. Severity of ARDS measured using APCHE II (Acute Physiology and Chronic Health Evaluation) score during hospitalization 2. Organ function assessed using Sequential Organ Failure Assessment (SOFA) with parameters of GCS level, PaO2/FiO2, vital signs, level of serum creatinine, alanine aminotransferase (ALT), total bilirubin, prothrombin time (PT), activated partial thromboplastin time (aPTT), platelet count, C-reactive protein (CRP), and lactate at baseline (pre-infusion), day 1, 3, 7 post-infusion, and 1-month post-infusion 3. Adverse events of stem cell transplantation including immune response, hyperreactivity, anaphylactic shock, incidental malignancy recorded using pulmonary X-ray or other imaging systems at 12 months post-infusion

—

Countries

Taiwan

Contacts

Public ContactHon-Kan Yip

han.gung@msa.hinet.net+886 (0)7 7317123 ext. 8300

Outcome results

None listed

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