Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:47 PM
Ignite Modification Date:
2025-12-24 @ 12:47 PM
NCT ID:
NCT04456361
Eligibility Criteria:
Inclusion Criteria:
* Ability to understand and the willingness to provide informed consent or a legally authorized representative.
* Diagnosis of Acute Respiratory Distress Syndrome according to the Berlin Definition following the failing of prior standard therapy, and other available therapies.
Mild: 200 mm Hg \< PaO2/FIO2 ≤ 300 mm Hg with PEEP or CPAP ≥ 5 cm H2Oc Moderate: 100 mm Hg \< PaO2/FIO2 ≤ 200 mm Hg with PEEP ≥ 5 cm H2O Severe: PaO2/FIO2 ≤ 100 mm Hg with PEEP ≥ 5 cm H2O
* Diagnostic test positive for SARS-CoV-2
* Age ≥ 18 years
* Any man with a partner of child-bearing potential agrees to use adequate contraception which will include two of the following: hormonal or barrier method of birth control, or abstinence prior to study entry, for the duration of study participation, and for 30 days following completion of therapy.
Exclusion Criteria:
* Current or anticipated use of other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to MSC infusion plus any patently atopic patients who have a history of having experienced an episode of allergic anaphylaxis.
* Severe or uncontrolled medical disorder that would, in the investigator's opinion, impair ability to receive study treatment (i.e., uncontrolled diabetes, chronic renal disease).
* Known diagnosis of human immunodeficiency virus (HIV) infection.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04456361
Study Brief:
Protocol Section:
NCT04456361