Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respi… (NCT04390139) | Clinical Trial Compass
CompletedPhase 1/2
Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19
Spain26 participantsStarted 2020-05-13
Plain-language summary
Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.
Who can participate
Age range
18 Years – 75 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
. Positive PCR fpr SARS-CoV-2
. Intensive Care Unit admission for less than 3 days
. Signed informed consent by the patient or by a legal representative (in this case, can be obtained by phone, although it must be confirmed in writing later, accepted by email)
Exclusion criteria
. Expected survival less than 3 days
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 used mesenchymal stem cells to treat severe COVID-19 respiratory distress — since it's now completed, has the data been published, and what did it show about survival at 28 days compared to standard care?
2Because this was a Phase 1/2 trial, the main goal was still establishing safety alongside early efficacy signals — what does that mean for how confident we can be in the results, and would you consider the evidence strong enough to inform my treatment decisions?
3The trial focused on adult respiratory distress syndrome caused by COVID-19 specifically — does my current respiratory condition match the severity level that was studied, and would stem cell therapy even be relevant for my situation?
4Are there any follow-on Phase 3 trials or expanded access programs for mesenchymal stem cell therapy in COVID-related lung disease that might be worth looking into, given this trial has already completed?
5Compared to what this trial was testing, what standard-of-care treatments are currently available for severe COVID-19 respiratory distress, and would those be a more proven option for me before considering experimental approaches like this one?
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.