BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Status and phase

Suspended

Phase 2

Conditions

Respiratory Distress Syndrome

COVID

Treatments

Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells

Study type

Interventional

Funder types

Other

NETWORK

Identifiers

NCT04348461

BALMYS-19

Details and patient eligibility

About

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.