Clinical trial NCT04348461: BAttLe Against COVID-19 Using MesenchYmal Stromal Cells
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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
Conditions: COVID
Respiratory Distress Syndrome
Lead sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Sponsor class: OTHER
Collaborators: name: Instituto de Investigación Sanitaria y Biomédica de Alicante
name: Hospital General Universitario Gregorio Marañon
name: Clinica Universidad de Navarra, Universidad de Navarra
name: University of Salamanca
name: Hospital General Universitario de Alicante
name: Hospital Universitario Virgen de la Arrixaca
First posted: 2020-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate)
timeFrame: 28 days
measure: Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
Study officials:
References: