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A Comparison Study of Repeated Intravenous Infusion of Allogeneic Mesenchymal Stem Cell from Different Sources in ARDS Patients

A Comparison Study on Safety & Efficacy of Repeated Intravenous Infusion of Allogeneic Mesenchymal Stem Cell from Different Sources in ARDS Patients: A Randomized, Double Blind, Clinical Trial Phase II

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20080901001165N44
Enrollment
12
Registered
2020-03-28
Start date
2020-03-29
Completion date
Unknown
Last updated
2020-04-21

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

Conditions

Acute respiratory distress syndrome (ARDS). Acute respiratory distress syndrome

Interventions

Intervention 1: First Intervention group: Wharton's jelly derived mesenchymal stem cells. Intervention 2: Second Intervention group: Amniotic membrane derived mesenchymal stem cells. Intervention 3: T

Sponsors

Bagheiat-allah University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Signed informed consent voluntarily Confirmed ARDS SOFA score between 2-3 point PaO2/FIO2 = 300 mmHg Mild to Moderate pneumonia/ stay in the ICU 50% in 24-48 hours

Exclusion criteria

Exclusion criteria: Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus Liver or kidney SOFA score of more than 3 points; combined with other organ failure Patients with malignant tumor Pregnant or lactating women Uncontrolled underling diseases Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia In vitro life support (ECMO, ECCO2R, RRT)

Design outcomes

Primary

MeasureTime frame
Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths). Timepoint: Before Intervention, Day 0 (First Intervention) till Day 7, Day 14, Day 28, 3 Moths, 6 Months and 12 months after intervention. Method of measurement: Fill Common Terminology Criteria for Adverse Events (CTCAE) Form.

Secondary

MeasureTime frame
PaO2/FiO2 assessment. Timepoint: Before Intervention, Day 0 (First Intervention) till Day 7, Day 14, Day 28, 3 Moths, 6 Months and 12 months after intervention. Method of measurement: Ventilator.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHoda Madani

Iranian academic center for education culture and research

hoda62_m@yahoo.com+98 21 2251 8388

Outcome results

None listed

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