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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04348461
Recruitment Status : Not yet recruiting
First Posted : April 16, 2020
Last Update Posted : April 16, 2020
Sponsor:
Collaborators:
Instituto de Investigación Sanitaria y Biomédica de Alicante
Hospital General Universitario Gregorio Marañon
Clinica Universidad de Navarra, Universidad de Navarra
Hospital Universitario de 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 April 16, 2020
Estimated Study Start Date  ICMJE April 6, 2020
Estimated 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 No Changes Posted
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: April 14, 2020)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2020
Estimated 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: Barbara Juan, MD 0034 915 50 48 00 ext 2431 barbara.soria@quironsalud.es
Contact: Mireia Arcas 0034 915 50 48 00 mireia.arcas@fjd.es
Listed Location Countries  ICMJE Not Provided
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
Responsible Party Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Study Sponsor  ICMJE Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators  ICMJE
  • Instituto de Investigación Sanitaria y Biomédica de Alicante
  • Hospital General Universitario Gregorio Marañon
  • Clinica Universidad de Navarra, Universidad de Navarra
  • Hospital Universitario de 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 April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP