NCT04348461

SuspendedPhase 2

BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz Source

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

ClinicalTrials.gov

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Other study identifiers

Sponsor study identifier

BALMYS-19

Study Type

interventional

Estimated enrollment

100

Locations

1 country

Sites

1

Timeline

Study Start

May 6, 2020

Actual (reported)

Primary Completion

September 15, 2020

Actual (reported)

Study Completion

September 30, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: suspended
Estimated enrollment: 100 participants
Study completion date: September 30, 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
April 10, 2020
Actual (reported)
First Posted
April 16, 2020
Actual (reported)
Study Start
May 6, 2020
Actual (reported)
Primary Completion
September 15, 2020
Actual (reported)
Study Completion
September 30, 2021
Estimated (date passed)
This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated: March 17, 2021
Status Verified: May 2020
Last Update Submitted: March 15, 2021

Conditions

COVID Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

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

Study Arms (2)

Control

NO INTERVENTION

Patients receiving regular respiratory distress treatment

Treatment

EXPERIMENTAL

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

Interventions

Allogeneic and expanded adipose tissue-derived mesenchymal stromal cellsDrug

Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg

Treatment

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Patients of both sexes.
Over 18 years.

Sponsors & Collaborators

Hospital General Universitario de Alicante
Othercollaborator
Instituto de Investigación Sanitaria y Biomédica de Alicante
Research networkcollaborator

Study Sites (1)

Fundacion Jimenez Diaz

Madrid, 28002, Spain

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: QUADRUPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 10, 2020

First Posted

April 16, 2020

Study Start

May 6, 2020

Actual (reported)

Primary Completion

September 15, 2020

Actual (reported)

NCT04404218

The Açaí Berry COVID-19 Anti-Inflammation Trial

Phase 2Unknown

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A Single-blinded, Randomized, Placebo Controlled Phase II Trial of Prophylactic Treatment With Oral Azithromycin Versus Placebo in Cancer Patients Undergoing Antineoplastic Treatment During the Corona Virus Disease 19 (COVID-19) Pandemic

Phase 2Completed

NCT04408040

Use of Convalescent Plasma for COVID-19

Phase 2Terminated

NCT04445467

An Adaptive Clinical Trial of Antivirals for COVID-19 Infection

Phase 2Unknown

NCT04402944

Pulmozyme to Improve COVID-19 ARDS Outcomes

Phase 2Unknown

NCT04359901

Sarilumab for Patients With Moderate COVID-19 Disease

Phase 2Completed

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.

Hospital General Universitario Gregorio Marañon

Othercollaborator

University of Salamanca

Othercollaborator

Hospital Universitario Virgen de la Arrixaca

Othercollaborator

Clinica Universidad de Navarra, Universidad de Navarra

Othercollaborator

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Otherlead

Study Completion

September 30, 2021

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

Last Updated

March 17, 2021

Record last verified: 2020-05

Source record

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Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT04348461
Data provider: ClinicalTrials.gov
Source updated: 2021-03-17
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:24:43 UTC

Locations

ES(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Control

Treatment

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations