Umbilical cord exosomes for reducing inflammation in COVID-19 ARDS

Randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of human umbilical cord MSC–derived exosomes (hUCMSC-Exos) in COVID-19–associated ARDS (Pilot study)

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20190101042197N2

Enrollment

Registered

2021-04-19

Start date

2021-05-20

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Acute Respiratory Distress Syndrome due to COVID-19. Acute respiratory distress syndrome

Interventions

Intervention 1: A total of 30 patients (15 in the intervention group and 15 in the control group) are randomly assigned in a 1:1 ratio. The intervention group receives a single intravenous dose of hum

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 18 to 65 years Gender: Both PCR-confirmed COVID-19 moderate-to-severe ARDS (PaO2/FiO2 < 200) SpO2 < 93% on oxygen bilateral infiltrates on imaging written informed consent

Exclusion criteria

Exclusion criteria: Malignancy pregnancy hepatic/renal failure lung or bone marrow transplant autoimmune/metabolic disease dialysis contagious infection active epilepsy coagulopathy

Design outcomes

Primary

Measure	Time frame
Tumor necrosis factor alpha (TNF-a). Timepoint: Baseline to day 7. Method of measurement: It is measured in serum blood samples using an ELISA kit.;CRP. Timepoint: Change from baseline to day 7. Method of measurement: Measurement is performed in serum using an immunoassay kit.;Serious Adverse Event (SAEs). Timepoint: Serious adverse events up to day 7. Method of measurement: Recorded from medical records and direct observation.;IL-6. Timepoint: Change from baseline to day 7. Method of measurement: Measurement is performed in serum using an ELISA kit.;CD3+, CD4+, CD8+ lymphocytes. Timepoint: Change from baseline to day 7. Method of measurement: Measurement is performed using a flow cytometry device.;D-dimer. Timepoint: Changes from baseline to day 7. Method of measurement: Measurement is performed using the ELISA method.;PRIEST score. Timepoint: Change up to day 7. Method of measurement: Assessment is performed by the treating physician according to standard guidelines.;Chest imaging. Timepoint: Changes on day 3. Method of measurement: Assessment is performed using chest radiography and radiological interpretation.;Length of hospital stay. Timepoint: Until discharge. Method of measurement: Recorded from the clinical file.	—

Measure

Time frame

Tumor necrosis factor alpha (TNF-a). Timepoint: Baseline to day 7. Method of measurement: It is measured in serum blood samples using an ELISA kit.;CRP. Timepoint: Change from baseline to day 7. Method of measurement: Measurement is performed in serum using an immunoassay kit.;Serious Adverse Event (SAEs). Timepoint: Serious adverse events up to day 7. Method of measurement: Recorded from medical records and direct observation.;IL-6. Timepoint: Change from baseline to day 7. Method of measurement: Measurement is performed in serum using an ELISA kit.;CD3+, CD4+, CD8+ lymphocytes. Timepoint: Change from baseline to day 7. Method of measurement: Measurement is performed using a flow cytometry device.;D-dimer. Timepoint: Changes from baseline to day 7. Method of measurement: Measurement is performed using the ELISA method.;PRIEST score. Timepoint: Change up to day 7. Method of measurement: Assessment is performed by the treating physician according to standard guidelines.;Chest imaging. Timepoint: Changes on day 3. Method of measurement: Assessment is performed using chest radiography and radiological interpretation.;Length of hospital stay. Timepoint: Until discharge. Method of measurement: Recorded from the clinical file.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMehrdad Dargahi

Ahvaz University of Medical Sciences

Dargahi-m@ajums.ac.ir+98 61 3333 3050

Outcome results

None listed

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