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BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

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: NCT04348461
Recruitment Status : Suspended (lack of financial support)
First Posted : April 16, 2020
Last Update Posted : March 17, 2021
Sponsor:
Collaborators:
Instituto de Investigación Sanitaria y Biomédica de Alicante
Hospital General Universitario Gregorio Marañon
Clinica Universidad de Navarra, Universidad de Navarra
University of Salamanca
Hospital General Universitario de Alicante
Hospital Clínico Universitario Virgen de la Arrixaca
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Study Description
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Brief Summary:

The investigational medicinal product consists of expanded allogeneic mesenchymal stromal cells derived from adipose tissue and administered intravenously.

The objective of this project is to evaluate the safety and efficacy of the administration of expanded allogeneic adipose tissue adult mesenchymal stem cells, in patients infected with SARS-COV-2 with COVID-19 type complications.


Condition or disease Intervention/treatment Phase
COVID Respiratory Distress Syndrome Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Two-treatment,Randomized, Controlled, Multicenter Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Expanded Allogeneic Adipose Tissue Adult Mesenchymal Stromal Cells in Critically Ill Patients COVID-19
Actual Study Start Date : May 6, 2020
Actual Primary Completion Date : September 15, 2020
Estimated Study Completion Date : September 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control
Patients receiving regular respiratory distress treatment
Experimental: Treatment
Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
 Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg


Outcome Measures
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Primary Outcome Measures :
  1. Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate) [ Time Frame: 28 days ]
  2. Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate [ Time Frame: 6 months ]

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

Inclusion Criteria:

  • Patients of both sexes.
  • Over 18 years.
  • Confirmation of SARS-COV-2 infection by RT-PCR in respiratory sample.
  • Respiratory failure requiring intubation and connection to mechanical ventilation, secondary to SARS-CoV-2 infection.
  • Criteria for acute respiratory distress: acute bilateral alveolar-interstitial infiltrate not compatible with left ventricular failure (demonstrated with ultrasound or hemodynamic parameters), sudden onset, and blood gas compromise with a PaO2 / FiO2 ratio <200 mm-Hg.
  • Women of childbearing potential should have a negative urine pregnancy test performed at the time of study enrollment.
  • Written or verbal informed consent from the patient, family member or legal representative.

Exclusion Criteria:

  • Any other cause of acute respiratory distress not attributable to SARS-Cov-2.
  • RT-PCR of SARS-Cov-2 negative.
  • Multi-organ failure (more than three organs)
  • Severe respiratory failure requiring extracorporeal support (ECMO) Grave Moderate severe COPD requiring chronic home oxygen therapy, need for prior home oxygen therapy for any reason.
  • Pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures.
  • Active tumor disease.
  • Previous immunosuppressive treatment.
  • Allergy or hypersensitivity to the administered products.
  • History of deep vein thrombosis or pulmonary embolism in the last 3 years.
  • Participation in other clinical trials during the 3 months prior to the initial visit.
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): NCT04348461


Locations
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Spain
Fundacion Jimenez Diaz
Madrid, Spain, 28002
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Instituto de Investigación Sanitaria y Biomédica de Alicante
Hospital General Universitario Gregorio Marañon
Clinica Universidad de Navarra, Universidad de Navarra
University of Salamanca
Hospital General Universitario de Alicante
Hospital Clínico Universitario Virgen de la Arrixaca
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT04348461    
Other Study ID Numbers: BALMYS-19
First Posted: April 16, 2020    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: May 2020

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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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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Lung Diseases
Respiratory Tract Diseases
 Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases