Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-24 @ 5:19 PM
Study NCT ID:
NCT04389450
Status:
TERMINATED
Last Update Posted:
2024-08-30
First Post:
2020-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Double-Blind, Multicenter, Study to Evaluate the Efficacy of PLX PAD for the Treatment of COVID-19
Sponsor:
Pluristem Ltd.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Phase II Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX PAD for the Treatment of Severe COVID-19
Status:
TERMINATED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
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
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: