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

Phase 1

Completed

• Conditions: Sars-CoV2
• Interventions: Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

• Registration Number: NCT04366323
• Lead Sponsor: Andalusian Network for Design and Translation of Advanced Therapies

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-22
• Study Start: 2020-04-27
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Primary Completion: 2021-12-30
• Study Completion: 2021-12-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (6)

Hospital Universitario de Jerez de la Frontera; 🇪🇸 Jerez de la Frontera, Cádiz, Spain

Hospital Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario Virgen de las Nieves; 🇪🇸 Granada, Spain

Hospital Unversitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Sevilla, Spain

Hospital Nuestra Señora de Valme; 🇪🇸 Sevilla, Spain