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

April 5, 2022 updated by: Andalusian Network for Design and Translation of Advanced Therapies

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 14004
        • Hospital Reina Sofía
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41014
        • Hospital Nuestra Señora de Valme
      • Sevilla, Spain, 41013
        • Hospital Unversitario Virgen del Rocío
    • Cádiz
      • Jerez de la Frontera, Cádiz, Spain, 11407
        • Hospital Universitario de Jerez de la Frontera

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Experimental
Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
Two doses of 80 million adipose-tissue derived mesenchymal stem cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
Time Frame: 12 months
12 months
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Andalusian Network for Design and Translation of Advanced Therapies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 27, 2020

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

December 30, 2021

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

April 5, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AdiQure/COVID-19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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