BAttLe Against COVID-19 Using MesenchYmal Stromal Cells
NCT ID: NCT04348461
Last Updated: 2021-03-17
Study Results
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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SUSPENDED
PHASE2
100 participants
INTERVENTIONAL
2020-05-06
2021-09-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Control
Patients receiving regular respiratory distress treatment
No interventions assigned to this group
Treatment
Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg
Interventions
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Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Instituto de Investigación Sanitaria y Biomédica de Alicante
NETWORK
Hospital General Universitario Gregorio Marañon
OTHER
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
University of Salamanca
OTHER
Hospital General Universitario de Alicante
OTHER
Hospital Universitario Virgen de la Arrixaca
OTHER
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Responsible Party
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Locations
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Fundacion Jimenez Diaz
Madrid, , Spain
Countries
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Other Identifiers
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BALMYS-19
Identifier Type: -
Identifier Source: org_study_id
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