BAttLe Against COVID-19 Using MesenchYmal Stromal Cells

NCT04348461 | Suspended Phase 2

• 1 other identifier: BALMYS-19
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Respiratory Distress Syndrome

Outcome Measures

Primary Outcomes (2)

• Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate)

  28 days

• Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate

  6 months

Study Arms (2)

Control

NO INTERVENTION

Patients receiving regular respiratory distress treatment

Treatment

EXPERIMENTAL

Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells

Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells

Interventions

Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells DRUG

Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Instituto de Investigación Sanitaria y Biomédica de Alicante: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator
• University of Salamanca: collaborator
• Hospital General Universitario de Alicante: collaborator
• Hospital Universitario Virgen de la Arrixaca: collaborator

Study Sites (1)

Fundacion Jimenez Diaz

Madrid, 28002, Spain

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2020
• First Posted: April 16, 2020
• Study Start: May 6, 2020
• Primary Completion: September 15, 2020
• Study Completion: September 30, 2021
• Last Updated: March 17, 2021

Record last verified: 2020-05

Locations

ES (1)