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 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
1 other identifier
interventional
26
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Apr 2020
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2020
CompletedStudy Start
First participant enrolled
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2021
CompletedApril 6, 2022
April 1, 2022
1.7 years
April 22, 2020
April 5, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Experimental
EXPERIMENTALControl
NO INTERVENTIONInterventions
Two doses of 80 million adipose-tissue derived mesenchymal stem cells
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, 11407, Spain
Hospital Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario Virgen de las Nieves
Granada, 18014, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Unversitario Virgen del Rocío
Seville, 41013, Spain
Hospital Nuestra Señora de Valme
Seville, 41014, Spain
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 22, 2020
First Posted
April 28, 2020
Study Start
April 27, 2020
Primary Completion
December 30, 2021
Study Completion
December 30, 2021
Last Updated
April 6, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share