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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-27

Study Completion Date

2021-12-30

Brief Summary

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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

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Detailed Description

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Conditions

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Sars-CoV2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Group Type EXPERIMENTAL

ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

Intervention Type DRUG

Two doses of 80 million adipose-tissue derived mesenchymal stem cells

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

Two doses of 80 million adipose-tissue derived mesenchymal stem cells

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No