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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial studied multiple doses of mesenchymal stromal cells in patients with moderate or severe ARDS from COVID-19 — since it's now completed, can you tell me what the results showed about infusion-related safety, including any serious adverse events like hemodynamic or breathing complications that were recorded?
2Because this was a Phase 2 trial, the main goal was still testing safety rather than confirming the treatment works — does that mean the benefit evidence is still considered preliminary, and how does that affect whether this approach might be right for my situation?
3The trial gave patients more than one infusion of MSCs — if this kind of treatment were considered for me, what would multiple infusions actually involve in terms of hospital stays, monitoring, and how demanding that process might be?
4Are there standard treatments for moderate or severe ARDS that my care team would recommend trying first before considering a cell therapy approach like the one studied in this trial?
5Since this trial has completed, is the data published or available, and are there follow-up studies or similar trials that might be worth discussing as next steps if this approach looks promising?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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