MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome

Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04525378

Enrollment

Registered

2020-08-25

Start date

2020-07-01

Completion date

2020-10-31

Last updated

2020-08-26

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

Conditions

ARDS, Human, Covid19

Brief summary

Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.

Interventions

OTHERMesenchymal stromal cell-based therapy

Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Clinical diagnosis of COVID-19 confirmed by RT-PCR; * Thorax CT image suggestive of viral pneumonia; * Respiratory failure (SaO2 \<93% with O2 at 5L / min) * Tracheal intubation (first 48 h);

Exclusion criteria

* Pregnancy or breastfeeding; * Patients with a history of cancer, chemotherapy in the past 2 years; * Life expectancy less than 6 months or in exclusive palliative care; * Severe liver failure, with Child-Pugh score\> 12; * High probability of death in the following 48 h; * Previous renal failure: patients who were already on dialysis or patients with RFG \<30ml / min / 1.73 m2; * Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.

Design outcomes

Primary

Measure	Time frame
Intrahospital mortality	28 days

Secondary

Measure	Time frame	Description
Days without mechanical ventilation in 28 days	28 days	—
PaO2 / FiO2 ratio	Day 1, Day 2 and Day 7 after cell infusion	—
Length of stay in the ICU and Hospital	28 days	—
Incidence of adverse events	28 days	—
Quantification of inflammatory response markers	Day 1, Day 3 and Day 7 after cell infusion	Exploratory evaluation of changes from baseline (percentage) in serum levels of CRP, LDH, Ferritin levels, a panel of cytokines, chemokines immune cell populations by flow cytometry
Incidence of secondary infections	28 days	—

Countries

Brazil

Contacts

Primary ContactBruno SF Souza, MD PHD

bruno.souza@hsr.com.br+557132816455

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026