Summary

Eligibility
for people ages 40-80 (full criteria)
Location
at UC Davis UC Irvine
Dates
study started
estimated completion

Description

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.

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

Keywords

COVID ARDS PLX-PAD

Eligibility

You can join if…

Open to people ages 40-80

  • Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.
  • Male or non-pregnant female adult 40-80 years of age at time of enrollment.
  • Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization.
  • Meets definition of ARDS according to Berlin criteria.

You CAN'T join if...

  • Body weight under 55 kg (121 lbs)
  • Serum creatinine level of over 1.5 mg/dL at time of randomization.
  • Total Bilirubin ≥2 mg/dL at time of randomization.
  • Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.
  • Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization.
  • Chronic Obstructive Pulmonary disease GOLD stage above II.

Locations

  • University of California Irvine not yet accepting patients
    Irvine California 92868 United States
  • University Of California Davis,4860 Y Street not yet accepting patients
    Sacramento California 95817 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pluristem Ltd.
Links
Related Info
ID
NCT04389450
Phase
Phase 2
Study Type
Interventional
Last Updated