This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.
This is a Phase II multi-center, double-blind, placebo-controlled, randomized study in Patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens. The study will enroll up to 40 Patients into two cohorts, randomized 1:1 to receive active study drug plus standard treatment or placebo (LRS) plus standard treatment. On the treatment (Day 0) Cohort 1 will receive a single IV dose of hMSCs Cohort 2 will receive Lactated Ringer's Solution. A second dose of MSCs or LRS will be given to Cohort 1 or Cohort 2, respectively on Day 3 after the first dose. Patients who discontinue the study before Month 1 for reasons other than adverse events will be replaced.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
IV administration
Providence Medical Foundation
Fullerton, California, United States
RECRUITINGProvidence Saint John's Health Center - Saint John's Cancer Institute
Santa Monica, California, United States
RECRUITINGSurvival
Number of patients alive at day 14 post treatment
Time frame: 14 days post treatment
Number of patients with treatment-related adverse events as assessed by CTCAE v4.0
Frequency of adverse events in patients treated with hMSCs and Lactate Ringer's solutions will be compared.
Time frame: 9 months
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