BAttLe Against COVID-19 Using MesenchYmal Stromal Cells
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ClinicalTrials.gov Identifier: NCT04348461 |
Recruitment Status :
Suspended
(lack of financial support)
First Posted : April 16, 2020
Last Update Posted : March 17, 2021
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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
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Tracking Information | |||||
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First Submitted Date ICMJE | April 10, 2020 | ||||
First Posted Date ICMJE | April 16, 2020 | ||||
Last Update Posted Date | March 17, 2021 | ||||
Actual Study Start Date ICMJE | May 6, 2020 | ||||
Actual Primary Completion Date | September 15, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | BAttLe Against COVID-19 Using MesenchYmal Stromal Cells | ||||
Official Title ICMJE | 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 | ||||
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. |
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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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | 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
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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 | Suspended | ||||
Estimated Enrollment ICMJE |
100 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | September 30, 2021 | ||||
Actual Primary Completion Date | September 15, 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 | 18 Years and older (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 | NCT04348461 | ||||
Other Study ID Numbers ICMJE | BALMYS-19 | ||||
Has Data Monitoring Committee | Not Provided | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE |
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Investigators ICMJE | Not Provided | ||||
PRS Account | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | ||||
Verification Date | May 2020 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |