BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

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

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.

Study Overview

• Status: Suspended
• Conditions: COVID; Respiratory Distress Syndrome
• Intervention / Treatment: Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28002
    • Fundacion Jimenez Diaz

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients receiving regular respiratory distress treatment
Experimental: Treatment; Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate)	28 days
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate	6 months

Collaborators and Investigators

• Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Collaborators: Hospital General Universitario Gregorio Marañon; Clinica Universidad de Navarra, Universidad de Navarra; University of Salamanca; Hospital General Universitario de Alicante; Hospital Clínico Universitario Virgen de la Arrixaca; Instituto de Investigación Sanitaria y Biomédica de Alicante

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2020
• Primary Completion (Actual): September 15, 2020
• Study Completion (Anticipated): September 30, 2021

Study Registration Dates

• First Submitted: April 10, 2020
• First Submitted That Met QC Criteria: April 14, 2020
• First Posted (Actual): April 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Infant, Newborn, Diseases; Infant, Premature, Diseases; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
• Other Study ID Numbers: BALMYS-19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No