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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
Sponsor:
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
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
 (submitted: April 14, 2020)
  • 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 ]
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.
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
Condition  ICMJE
  • COVID
  • Respiratory Distress Syndrome
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
Study Arms  ICMJE
  • No Intervention: Control
    Patients receiving regular respiratory distress treatment
  • Experimental: Treatment
    Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
    Intervention: Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: April 14, 2020)		 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:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
  • 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
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