Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19) (NCT04466098) | Clinical Trial Compass
CompletedPhase 2
Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19)
United States8 participantsStarted 2020-07-30
Plain-language summary
This is a multi-center, randomized, placebo controlled, interventional phase 2A trial to evaluate the safety profile and potential efficacy of multi-dosing of mesenchymal stromal cells (MSC) for patients with SARS-CoV-2 associated Acute Respiratory Distress Syndrome (ARDS). After informed consent, treatment assignment will be made by computer-generated randomization to administer either MSC or vehicle placebo control with a 2:1 allocation to the MSC: placebo arm.
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age 18-80 years
* Meets 'Berlin Criteria' for diagnosis of moderate to severe ARDS for a minimum of 4 hours
* Less than 48 hours on a ventilator after meeting criteria for diagnosis of ARDS
* SARS-CoV-2 (proven by RT-PCR assay) with radiographic infiltrates
* PaO2/FiO2 \< 250
* Positive end-expiratory airway pressure (PEEP) \>5 cm H20
* Elevated C-reactive protein (above laboratory upper limit of normal)
* Meets organ function requirements, including left ventricular ejection fraction (LVEF) \>35% ( as defined below)
* Off other investigational agents directed against inflammatory cytokines 48 hours prior to enrollment; agents directed against the replication of SARS-CoV-2 \[e.g., Remdesivir\] are permitted
* Voluntary informed consent in person or virtually by the patient or patient surrogate considering the face to face limitations during the COVID-19 pandemic and, given the nature of the study population, which frequently requires mechanical ventilation with sedation, surrogate consent will likely occur in a substantial proportion of the study population (this will remain a valid consent until the patient is fully alert, and aware, and can provide a second consent to continue participation in the study).
* Adequate organ function is defined as:
* Renal: Calculated estimated glomerular filtration rate \>30 mL/min/1.73 m2 (on chemistry panel)
* Hepatic: Bilirubin \<3x upper limit of normal (ULN) and AST, ALT and alkaline phosphatase \<5x ULN
* C…
What they're measuring
1
Incidence of Grade 3-5 Infusional Toxicities and Predefined Hemodynamic or Respiratory Adverse Events Related to the Infusion of MSC
Timeframe: Within 6 hours of the start of the infusion
Trial details
NCT IDNCT04466098
SponsorMasonic Cancer Center, University of Minnesota