MESENCHYMAL STROMAL CELL THERAPY FOR THE TREATMENT OF ACUTE RESPIRATORY DISTRESS SYNDROME
- Conditions
- Acute respiratory distress syndrome (ARDS)MedDRA version: 21.1Level: PTClassification code 10001052Term: Acute respiratory distress syndromeSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2019-004462-18-SE
- Lead Sponsor
- ppsala University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 9
1. Willing and able to provide written informed consent prior to performing study procedures (and have given written consent)
2. Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test at screening
3. Male or female patient aged 18 to 65 years old
4.Patient must fulfil the Berlin Definition of severe ARDS within 3 weeks to 48 hours prior to inclusion (Will be assessed once the patient has been admitted to the ICU)
5. Patient is on respirator support within 3 weeks to 48 hours prior to inclusion (Will be assessed once the patient has been admitted to the ICU)
6. Pregnancy test in blood confirming negative results before enrolment (for women =55 years old)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 8
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1
1. 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
2. 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
3. Pregnant or breast feeding female
4. Patient with a history of anti-coagulation therapy for other indications that short-term prophylaxis after surgery.
5. 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).
6. 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).
7. Prisoner
8. Any other irreversible disease or condition for which six-month mortality is estimated to be greater than 50%
9. Moderate to severe liver failure (Child-Pugh Score >12)
10. Reduced renal function with a creatinine clearance (Cockcroft-Gault Equation) < 45 mL/min/1.73m2
11. Severe chronic respiratory disease with a PaCO2 >50 mmHg or the use of home oxygen
12. Major trauma in the prior 5 days
13. Lung transplant patient
14. Patients on ECMO-support
15. Patients with a previous history of severe burns
16. Documented deep venous thrombosis or pulmonary embolism within past three months
17. Known hypersensitivity to DMSO
18.
Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method