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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04366323
Recruitment Status : Active, not recruiting
First Posted : April 28, 2020
Last Update Posted : November 30, 2020
Sponsor:
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies

Study Description
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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

Condition or disease Intervention/treatment Phase
Sars-CoV2 Drug: ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : April 27, 2020
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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


Outcome Measures
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Primary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04366323


Locations
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Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Cádiz, Spain, 11407
Hospital Reina Sofía
Córdoba, Spain, 14004
Hospital Universitario Virgen de las Nieves
Granada, Spain, 18014
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Unversitario Virgen del Rocío
Sevilla, Spain, 41013
Hospital Nuestra Señora de Valme
Sevilla, Spain, 41014
Sponsors and Collaborators
Andalusian Network for Design and Translation of Advanced Therapies
More Information
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Responsible Party: Andalusian Network for Design and Translation of Advanced Therapies
ClinicalTrials.gov Identifier: NCT04366323    
Other Study ID Numbers: AdiQure/COVID-19
First Posted: April 28, 2020    Key Record Dates
Last Update Posted: November 30, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases