Back to resultsBAttLe Against COVID-19 Using MesenchYmal Stromal Cells
Primary Purpose
COVID, Respiratory Distress Syndrome
Status
Suspended
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
Sponsored by
About this trial
This is an interventional treatment trial for COVID
Eligibility Criteria
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.
Sites / Locations
- Fundacion Jimenez Diaz
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Treatment
Arm Description
Patients receiving regular respiratory distress treatment
Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
Outcomes
Primary Outcome Measures
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate)
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
Secondary Outcome Measures
Full Information
NCT ID
NCT04348461
First Posted
April 10, 2020
Last Updated
March 15, 2021
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
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
1. Study Identification
Unique Protocol Identification Number
NCT04348461
Brief Title
BAttLe Against COVID-19 Using MesenchYmal Stromal Cells
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Suspended
Why Stopped
lack of financial support
Study Start Date
May 6, 2020 (Actual)
Primary Completion Date
September 15, 2020 (Actual)
Study Completion Date
September 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID, Respiratory Distress Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Patients receiving regular respiratory distress treatment
Arm Title
Treatment
Arm Type
Experimental
Arm Description
Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
Intervention Type
Drug
Intervention Name(s)
Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
Intervention Description
Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg
Primary Outcome Measure Information:
Title
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate)
Time Frame
28 days
Title
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fundacion Jimenez Diaz
City
Madrid
ZIP/Postal Code
28002
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
BAttLe Against COVID-19 Using MesenchYmal Stromal Cells
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