Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST) (NCT03042143) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration (REALIST)
United Kingdom129 participantsStarted 2019-01-07
Plain-language summary
Acute Respiratory Distress Syndrome (ARDS) causes the lungs to fail due to the collection of fluid in the lungs (pulmonary oedema). ARDS is common in severely ill patients in Intensive Care Units and is associated with a high mortality and a high morbidity in those who survive. ARDS occurs in approximately 20% case of COVID-19 and respiratory failure is the leading cause of mortality. There is a large economic burden with direct healthcare costs, but also indirectly due to the impact on the carer and patient through the patients inability to return to full time employment. There is little evidence for effective drug (pharmacological) treatment for ARDS. There is increasing information that mesenchymal stem cells (MSCs) might be important in treating ARDS. REALIST will investigate if a single infusion of MSCs will help in the treatment of ARDS. The first step will be to first of all determine what dose of MSCs is safe and then divide patients suffering from ARDS into two groups, one of which will get MSCs and the other a harmless dummy (or placebo) infusion, who will then be followed up to determine if lung function improves. If effective this may lead to further research to determine if MSCs are effective in patients with ARDS.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. ARDS as defined by the Berlin definition.
✓. Onset within 1 week of identified insult.
✓. Within the same 24-hour time period i. Hypoxic respiratory failure (PaO2/ FiO2 ratio ≤ 27kPa on PEEP ≥ 5 cmH20) ii. Bilateral infiltrates on chest X-ray consistent with pulmonary oedema not explained by another pulmonary pathology iii. Respiratory failure not fully explained by cardiac failure or fluid overload
✓. Patient is receiving invasive mechanical ventilation
✓. COVID-19 based on clinical diagnosis or PCR result or other causes of ARDS.
Exclusion criteria
✕. More than 72 hours from the onset of ARDS.
✕. Age \< 16 years.
✕. Patient is known to be pregnant
✕. Major trauma in the prior 3 days.
✕. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last year.