BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

Phase 2

Suspended

• Conditions: COVID; Respiratory Distress Syndrome
• Interventions: Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells

• Registration Number: NCT04348461
• Lead Sponsor: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-10
• Study First Submitted QC: 2020-04-14
• Study First Posted: 2020-04-16
• Status Verified: 2020-05
• Study Start: 2020-05-06
• Primary Completion: 2020-09-15
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells	Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells

Primary Outcome Measures

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

Trial Locations

Locations (1)

Fundacion Jimenez Diaz; 🇪🇸 Madrid, Spain