BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

Sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz (Other)

Overall Status

Suspended

CT.gov ID

NCT04348461

Collaborator

Instituto de Investigación Sanitaria y Biomédica de Alicante (Other), Hospital General Universitario Gregorio Marañon (Other), Clinica Universidad de Navarra, Universidad de Navarra (Other), University of Salamanca (Other), Hospital General Universitario de Alicante (Other), Hospital Clínico Universitario Virgen de la Arrixaca (Other)

100

Enrollment

Location

Arms

16.8

Anticipated Duration (Months)

5.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID Respiratory Distress Syndrome	Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 6, 2020

Actual Primary Completion Date :

Sep 15, 2020

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fundacion Jimenez Diaz	Madrid		Spain	28002

Sponsors and Collaborators

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Instituto de Investigación Sanitaria y Biomédica de Alicante
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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

ClinicalTrials.gov Identifier:

NCT04348461

Other Study ID Numbers:

BALMYS-19

First Posted:

Apr 16, 2020

Last Update Posted:

Mar 17, 2021

Last Verified:

May 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Study Results

No Results Posted as of Mar 17, 2021