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Completed

NCT Number: NCT04366323

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 to evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Expanded in patients with severe COVID-19 pneumonia

Completed

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Key information

Conditions

Sars-CoV2

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Hospital Universitario de Jerez de la Frontera, Jerez de la Frontera, Cádiz, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS

Drug

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

Primary outcomes

  1. Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate

    Time frame: 12 months

  2. Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Andalusian Network for Design and Translation of Advanced Therapies

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 28, 2020
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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