Mesenchymal stromal cells as a new treatment for a disease called ARDS

Phase 1

• Conditions: Acute Respiratory Distress Syndrome; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-000584-33-GB
• Lead Sponsor: Belfast Health and Social Care Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-11-28
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 78

Inclusion Criteria

1. Moderate to severe ARDS as defined by the Berlin definition
a)Onset within 1 week of identified insult
b)Within the same 24-hour time period
i. Hypoxic respiratory failure (PaO2/ FiO2 ratio less than or equal to 27kPa on PEEP more than or equal to 5cmH2O)
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
2. Patient is receiving invasive mechanical ventilation
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

Exclusion Criteria

1. More than 48 hours from the onset of ARDS
2. Age <16 years
3. Patient is known to be pregnant
4. Participation in a clinical trial of an investigational medicinal product
within 30 days
5. Major trauma in the prior 5 days
6. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last year
7. WHO Class III or IV pulmonary hypertension
8. Venous thromboembolism currently receiving anti-coagulation or within the last 3 months.
9. Currently receiving extracorporeal life support (ECLS)
10. Severe chronic liver disease with Child-Pugh score >12
11. DNAR (Do Not Attempt Resuscitation) order in place
12. Treatment withdrawal imminent within 24 hours
13. Consent declined
14. Prisoners
15. Non-English speaking patients or those who do not adequately understand verbal or written information unless an interpreter is available
16. Previously enrolled in the REALIST trial

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified