BAttLe Against COVID-19 Using MesenchYmal Stromal Cells
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04348461|
Recruitment Status : Suspended (lack of financial support)
First Posted : April 16, 2020
Last Update Posted : March 17, 2021
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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 :||September 15, 2020|
|Estimated Study Completion Date :||September 30, 2021|
No Intervention: Control
Patients receiving regular respiratory distress 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
- Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate) [ Time Frame: 28 days ]
- Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate [ Time Frame: 6 months ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04348461
|Fundacion Jimenez Diaz|
|Madrid, Spain, 28002|
|Responsible Party:||Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz|
|Other Study ID Numbers:||
|First Posted:||April 16, 2020 Key Record Dates|
|Last Update Posted:||March 17, 2021|
|Last Verified:||May 2020|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases