Status:
ACTIVE_NOT_RECRUITING
Use of Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome Caused by COVID-19
Lead Sponsor:
Instituto de Medicina Regenerativa
Conditions:
ARDS, Human
Covid-19
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This is a pilot phase, open label, non-randomized study for the treatment of ARDS in patients infected with COVID-19. Subjects will be enrolled and treated with one dose of mesenchymal stem cells and ...
Detailed Description
A Study of Mesenchymal Stem Cells as a treatment in Patients with Acute Respiratory Distress Syndrome caused by COVID-19 is a pilot phase, open label, non-randomized study, with a single study center....
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 15 2025
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04456361
Start Date
April 16 2020
End Date
November 15 2025
Last Update
March 6 2024
Active Locations (1)
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1
Instituto de Medicina Regenerativa
Tijuana, Estado de Baja California, Mexico, 22100