BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

• ClinicalTrials.gov Identifier: NCT04348461
• Recruitment Status: Not yet recruiting
• First Posted: April 16, 2020
• Last Update Posted: April 16, 2020
• 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; 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: April 10, 2020
• First Posted Date: April 16, 2020
• Last Update Posted Date: April 16, 2020
• Estimated Study Start Date: April 6, 2020
• Estimated Primary Completion Date: September 15, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: BAttLe Against COVID-19 Using MesenchYmal Stromal Cells
• 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

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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment

Condition

• COVID
• Respiratory Distress Syndrome

Intervention

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

• 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

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: April 14, 2020): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 30, 2020
• Estimated Primary Completion Date: September 15, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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: Not Provided

Administrative Information

• NCT Number: NCT04348461
• Other Study ID Numbers: 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: Not Provided
• Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Study 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
• Hospital Universitario de Salamanca
• Hospital General Universitario de Alicante
• Hospital Clínico Universitario Virgen de la Arrixaca

• Investigators: Not Provided
• PRS Account: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
• Verification Date: April 2020