Sars-CoV2 Clinical Trial
Official title:
Phase I / II Clinical Trial, Multicenter, Randomized and Controlled, to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19
Verified date | April 2022 |
Source | Andalusian Network for Design and Translation of Advanced Therapies |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 26 |
Est. completion date | December 30, 2021 |
Est. primary completion date | December 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Reina Sofía | Córdoba | |
Spain | Hospital Universitario Virgen de las Nieves | Granada | |
Spain | Hospital Universitario de Jerez de la Frontera | Jerez de la Frontera | Cádiz |
Spain | Hospital Nuestra Señora de Valme | Sevilla | |
Spain | Hospital Universitario Virgen Macarena | Sevilla | |
Spain | Hospital Unversitario Virgen del Rocío | Sevilla |
Lead Sponsor | Collaborator |
---|---|
Andalusian Network for Design and Translation of Advanced Therapies |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate | 12 months | ||
Primary | Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate | 28 days |
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