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The decision to bring the Study to early clinical readout came in response to COVID-19's evolution as a disease, and the significant changes in the standard of care, leading to an increase in the severity of conditions of the intubated patients
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This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PLX-PAD interval high dose | Experimental | PLX-PAD will be administered via 15 IM injections (1 mL each). Each subject will be treated twice, with an interval of 1 week between treatments. |
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| PLX-PAD low dose | Experimental | PLX-PAD 300, single administration, second administration of placebo after 1 week. |
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| Control Group A | Placebo Comparator | Placebo, two administrations, 1 week apart |
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| PLX-PAD high dose | Experimental | PLX-PAD, single administration |
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| Control Group B | Placebo Comparator | Placebo, single administration |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PLX-PAD | Biological | PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of ventilator free days | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| All-cause mortality | 28 days | |
| Duration of mechanical ventilation | 8 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Irvine | California | 92868 | United States | ||
| University of Southern California (USC) - Keck School of Medicine (KSOM) |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Placebo | Biological | Placebo solution for injection |
|
| Los Angeles |
| California |
| 90033 |
| United States |
| University Of California Davis,4860 Y Street | Sacramento | California | 95817 | United States |
| Baptist Health Medical Center | Jacksonville | Florida | 32207 | United States |
| Medical College of Georgia at Augusta University | Augusta | Georgia | 30907 | United States |
| Sarah Cannon Research Institute, LLC (Mercer University School of Medicine) | Macon | Georgia | 31217 | United States |
| University of Mississippi Medical Center | Jackson | Mississippi | 39216 | United States |
| Cooper Research Institute | Camden | New Jersey | 08103 | United States |
| Holy Medical Center | Teaneck | New Jersey | 07666 | United States |
| Montefiore Medical Center | New York | New York | 10467 | United States |
| Maimonides Medical Center | New York | New York | 11219 | United States |
| Mercy Medical Center | New York | New York | 11570 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |