Status:
SUSPENDED
BAttLe Against COVID-19 Using MesenchYmal Stromal Cells
Lead Sponsor:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborating Sponsors:
Instituto de Investigación Sanitaria y Biomédica de Alicante
Hospital General Universitario Gregorio Marañon
Conditions:
COVID
Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 evaluat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 6 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2021
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04348461
Start Date
May 6 2020
End Date
September 30 2021
Last Update
March 17 2021
Active Locations (1)
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1
Fundacion Jimenez Diaz
Madrid, Spain, 28002