Clinical Trial 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
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ClinicalTrials.gov Identifier: NCT04366323 |
Recruitment Status :
Completed
First Posted : April 28, 2020
Last Update Posted : April 6, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Sars-CoV2 | Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 26 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 27, 2020 |
Actual Primary Completion Date : | December 30, 2021 |
Actual Study Completion Date : | December 30, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Experimental |
Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
Two doses of 80 million adipose-tissue derived mesenchymal stem cells |
No Intervention: Control |
- Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate [ Time Frame: 12 months ]
- Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate [ Time Frame: 28 days ]

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 18
- Clinical diagnosis of Pneumonia, severe or critical, caused by COVID-19 infection
- Life expectancy > 48 hours.
- Commitment to use a contraceptive method of proven efficacy in both men and women during the duration of the clinical trial.
Exclusion Criteria:
- Coinfection with other viruses or bacteria (HIV, tuberculosis, influenza virus, adenovirus or other respiratory infections, active infection by HBV or C).
- History of multiple allergies, including allergy to Penicillin or other Blactams.
- Pregnant and lactating women.
- Patients with malignant tumors or hemopathies or any state of immunosuppression considered as severe.
- Patients with autoimmune diseases.
- Chronic heart failure with ejection fraction less than 30%.
- Any other condition for which, in the opinion of the main investigator, the subject is considered not to be in compliance with the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366323
Spain | |
Hospital Universitario de Jerez de la Frontera | |
Jerez de la Frontera, Cádiz, Spain, 11407 | |
Hospital Reina Sofía | |
Córdoba, Spain, 14004 | |
Hospital Universitario Virgen de las Nieves | |
Granada, Spain, 18014 | |
Hospital Universitario Virgen Macarena | |
Sevilla, Spain, 41009 | |
Hospital Unversitario Virgen del Rocío | |
Sevilla, Spain, 41013 | |
Hospital Nuestra Señora de Valme | |
Sevilla, Spain, 41014 |
Responsible Party: | Andalusian Network for Design and Translation of Advanced Therapies |
ClinicalTrials.gov Identifier: | NCT04366323 |
Other Study ID Numbers: |
AdiQure/COVID-19 |
First Posted: | April 28, 2020 Key Record Dates |
Last Update Posted: | April 6, 2022 |
Last Verified: | April 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pneumonia Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases |