Clinical Trial of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With COVID-19 (MESCEL-COVID19)
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ClinicalTrials.gov Identifier: NCT04366271 |
Recruitment Status :
Withdrawn
(Lack of funding)
First Posted : April 28, 2020
Last Update Posted : August 27, 2021
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Tracking Information | |||||
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First Submitted Date ICMJE | April 23, 2020 | ||||
First Posted Date ICMJE | April 28, 2020 | ||||
Last Update Posted Date | August 27, 2021 | ||||
Actual Study Start Date ICMJE | May 7, 2020 | ||||
Actual Primary Completion Date | July 31, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Mortality due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment [ Time Frame: 28 days ] Percentage of patients death due to lung involvement due to SARS-CoV-2 virus infection at 28 days of treatment
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Clinical Trial of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With COVID-19 | ||||
Official Title ICMJE | Phase II Clinical Trial to Explore the Efficacy of Allogeneic Mesenchymal Cells From Umbilical Cord Tissue in Patients With Severe Pulmonary Involvement by COVID-19 | ||||
Brief Summary | The disease caused by the SARS-CoV-2 virus is a viral disease that infects the lungs, producing flu-like symptoms. Elderly infected patients and/or those with co-morbidities may suffer from acute respiratory distress syndrome due to pneumonia (COVID-19 disease). Given the high transmission, this virus has spread in recent months from Wuhan (China) to the whole world, becoming a global emergency pandemic. The lack of curative treatment for this disease justifies the need to carry out clinical trials that provide quality evidence on treatment options. Given the pathophysiology of the disease, which involves an uncontrolled inflammatory response of alveolar cells, a treatment that attenuates the cytokine cascade could be key in rescuing the patient's lung tissue. Mesenchymal cells, due to their immunoregulatory potential and regenerative capacity, can be an effective treatment for patients infected with the SARS-CoV-2 virus. In the present study we propose a therapy with undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue, a treatment whose safety has already been described in other clinical trials and that shows promising results in pilot studies carried out in China. |
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Detailed Description | Not Provided | ||||
Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | COVID | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Actual Enrollment ICMJE |
0 | ||||
Original Estimated Enrollment ICMJE |
106 | ||||
Actual Study Completion Date ICMJE | May 31, 2021 | ||||
Actual Primary Completion Date | July 31, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 40 Years to 80 Years (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | Spain | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT04366271 | ||||
Other Study ID Numbers ICMJE | MESCEL-COVID19 2020-001450-22 ( EudraCT Number ) |
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Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Current Responsible Party | Mrs. Laura Aranzasti, Hospital Infantil Universitario Niño Jesús, Madrid, Spain | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Hospital Infantil Universitario Niño Jesús, Madrid, Spain | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Apices Soluciones S.L. | ||||
Investigators ICMJE |
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PRS Account | Hospital Infantil Universitario Niño Jesús, Madrid, Spain | ||||
Verification Date | August 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |