Sars-CoV2
Conditions
Brief summary
Phase I/II clinical trial to evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Expanded in patients with severe COVID-19 pneumonia
Interventions
Two doses of 80 million adipose-tissue derived mesenchymal stem cells
Sponsors
Andalusian Network for Design and Translation of Advanced Therapies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 2. Clinical diagnosis of Pneumonia, severe or critical, caused by COVID-19 infection 3. Life expectancy \> 48 hours. 4. Commitment to use a contraceptive method of proven efficacy in both men and women during the duration of the clinical trial.
Exclusion criteria
1. Coinfection with other viruses or bacteria (HIV, tuberculosis, influenza virus, adenovirus or other respiratory infections, active infection by HBV or C). 2. History of multiple allergies, including allergy to Penicillin or other Blactams. 3. Pregnant and lactating women. 4. Patients with malignant tumors or hemopathies or any state of immunosuppression considered as severe. 5. Patients with autoimmune diseases. 6. Chronic heart failure with ejection fraction less than 30%. 7. Any other condition for which, in the opinion of the main investigator, the subject is considered not to be in compliance with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate | 12 months |
| Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate | 28 days |
Countries
Spain
Outcome results
None listed