Experimental cell treatment shows promise for COVID-19 lung failure
NCT ID NCT04447833
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage study tested a single dose of mesenchymal stromal cells in 7 COVID-19 patients with severe acute respiratory distress syndrome (ARDS) who were on ventilators. The main goal was to check safety, looking for serious side effects like heart problems or blood clots within 10 days. The study also tracked survival and changes in blood cells over time.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
7 people
The number who actually took part.
- Started
-
Jun 2020
- Finished
-
Apr 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Willing and able to provide written informed consent prior to performing study procedures (and have given written consent) * Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test at screening * Male or female patient aged 18 to 65 years old * Patient must fulfil the Berlin Definition of severe ARDS within 3 weeks to 48 hours prior to enrolment (Will be assessed once the patient has been admitted to the ICU) * Patient is on respirator support within 3 weeks to 48 hours prior to enrolment (Will be assessed once the patient has been admitted to the ICU) * Pregnancy test in blood confirming negative results before enrolment (for women ≤55 years old) Exclusion Criteria: * History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study * Patients with history of treated blood and/or solid organ malignancy with recurrence within five years prior to dosing of the ATIMP are to be excluded. Patients with history of cervix cancer and non-melanoma skin cancer with recurrence within two years prior to dosing of the ATIMP are to be excluded * Pregnant or breast feeding female * Patient with a history of anti-coagulation therapy for other indications that short-term prophylaxis after surgery * Patients with a history and/ or on-going treatment for entity associated with bleeding disorder or potential risk for bleeding (e.g. inflammatory bowel disease, gastro-esophagitis with or without ulcers, haemophilia and other bleeding disorders, inflammatory musculo-skeletal disease with potential bleeding complications) * Patients with a history during the latest five years and/or on-going treatment for systemic infection (e.g. Septicaemia due to in vivo foreign body (e.g. stents, catheters, heart valve), tuberculosis, malaria, other opportunistic and parasite infections) * Prisoner * Any other irreversible disease or condition for which six-month mortality is estimated to be greater than 50% * Moderate to severe liver failure (Child-Pugh Score \>12) * Reduced renal function with a creatinine clearance (Cockcroft-Gault Equation) \< 45 mL/min/1.73m2 * Severe chronic respiratory disease with a PaCO2 \>50 mmHg or the use of home oxygen * Major trauma in the prior 5 days * Lung transplant patient * Patients on ECMO-support * Patients with a previous history of severe burns * Documented deep venous thrombosis or pulmonary embolism within past three months * Known hypersensitivity to DMSO * Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for ARDS, human are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Uppsala University Hospital
Uppsala, 75185, Sweden
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- How does COVID-19 hit people born with weak immune systems?
- Pandemic pregnancy: tracking COVID's impact on mothers and babies
- AI may foresee lung complications after liver surgery
- What happens to the immune system after COVID-19? a major study aims to find out.
- Hidden toll of routine ICU procedure revealed: suctioning may spike pain and stress
- Why COVID-19 lungs fail: tiny blood vessel damage may be key