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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 80 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
PLX-PAD interval high dose 		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.
  • Biological: PLX-PAD
    PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Experimental
PLX-PAD low dose 		PLX-PAD 300, single administration, second administration of placebo after 1 week.
  • Biological: PLX-PAD
    PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Placebo Comparator
Control Group A 		Placebo, two administrations, 1 week apart
  • Biological: Placebo
    Placebo solution for injection
Experimental
PLX-PAD high dose 		PLX-PAD, single administration
  • Biological: PLX-PAD
    PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
Placebo Comparator
Control Group B 		Placebo, single administration
  • Biological: Placebo
    Placebo solution for injection

Recruiting Locations

More Details

NCT ID
NCT04389450
Status
Terminated
Sponsor
Pluristem Ltd.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.