BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

COVID Clinical Trial

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT04348461
• Other study ID #: BALMYS-19
• Status: Suspended
• Phase: Phase 2
• Start date: May 6, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: May 2020
• Source: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 100
• Est. completion date: September 30, 2021
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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

Locations

Country	Name	City	State
Spain	Fundacion Jimenez Diaz	Madrid

Sponsors (7)

Lead Sponsor	Collaborator
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz	Clinica Universidad de Navarra, Universidad de Navarra, Hospital Clínico Universitario Virgen de la Arrixaca, Hospital General Universitario de Alicante, Hospital General Universitario Gregorio Marañon, Hospital Universitario de Salamanca, Instituto de Investigación Sanitaria y Biomédica de Alicante

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate)		28 days
Primary	Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate		6 months