Mesenchymal Stem Cell for Acute Respiratory Distress Syndrome Due for COVID-19

NCT04416139 | Unknown Phase 2 DMC

• 1 other identifier: SCI-3354-20-21-1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Respiratory Distress Syndrome (ARDS) is the main cause of death from COVID-19. One of the main mechanisms for ARDS is the violent storm of cytokines and chemokines, which cause uncontrolled fatal systemic inflammation by the immune system on the body, with additional multiple organ failure. Mortality in cases of severe ARDS caused by COVID 19 varies significantly between 50 and 90%, basically depending on the age of the patient and the presence of comorbidities. The plasticity of Mesenchymal Stem Cells (MSC) regulates inflammation and immunity. MSC can promote and inhibit an immune response, depending on the dynamics of inflammation and depending on the activation force of the immune system, the types of inflammatory cytokines present, and the effects of immunosuppressants. Essentially, the state of inflammation determines the immunoregulatory fate of MSC. Thus, IV application of AMSCa has been shown to control the inflammatory response in various diseases, such as the graft-versus-host reaction and the ARDS caused by H5NI. The objective of this study is to describe the clinical changes secondary to IV administration of MSC allogenic, in patients with bilateral COVID-19 pneumonia complicated by severe ARDS, with the evaluation of the PaO2 / FiO2 ratio, heart and respiratory rates, and the fever curve. Five patients, of either sex, over 18 years of age, with bilateral pneumonia caused by COVID-19 and severe SIRA that has not improved with the standard management measures used at that time in the care center, will be included in the study. This treatment will be administered after discussing it with the relatives that it is a procedure considered as rescue and will be carried out with informed consent. 1x10(6) xKg will be applied IV. The follow-up of the patient will be for three weeks. PaO2 / FiO2 data, fever, inflammatory markers and immunity will be evaluated. The results will be compared with the historical controls attended at INCMNSZ.

Conditions

Covid 19

Keywords

Mesenchymal Stem Cell

Outcome Measures

Primary Outcomes (4)

• Functional Respiratory changes: PaO2 / FiO2 ratio

  To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the PaO2 / FiO2 ratio.

  Three weeks

• Clinical cardiac changes: Heart rate per minute

  To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the heart rate per minute.

  Three weeks

• Clinical Respiratory Changes: Respiratory rate per minute

  To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the respiratory rate per minute.

  Three weeks

• Changes in body temperature

  To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the fever curve in degrees centigrade.

  Three weeks

Secondary Outcomes (22)

• General biochemical changes in Leukocytes

  Three weeks

• General biochemical changes on lymphocytes

  Three weeks

• General biochemical changes on platelets

  Three weeks

• General biochemical changes on fibrinogen

  Three weeks

• General biochemical changes on pocalcitonin

  Three weeks

Study Arms (2)

Treated group

ACTIVE COMPARATOR

Five patients, of any sex and age, with bilateral COVID-19 pneumonia, severe SIRA with PaO2 / FiO2 less than 150, lymphopenia less than 800 total lymphocytes, CT with bilateral pneumonia, SOFA less than 11 and that has not improved in relation to the following parameters: a) persistent PaO2 / FiO2 less than 150; b) persistent fever, c) increase in D-dimer of at least 50% of the baseline and / or ferritin greater than 1000, after 48 h of hospital stay receiving the standard management measures used at that time in the Care Center, will be included in the study. This treatment will be administered after discussing it with the relatives that it is a procedure considered as rescue and will be carried out with informed consent.

Biological: Infusion IV of Mesenchymal Stem cells

Control Group

NO INTERVENTION

The results obtained in the treated group will be compared against the historical controls treated in INCMNSZ, evaluating the same variables.

Interventions

Infusion IV of Mesenchymal Stem cells BIOLOGICAL

Mesenchymal Stem cells from bank will be applied IV, at dose 1 million xKg in a single dose

Treated group

Eligibility Criteria

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

You may qualify if:

• Bilateral pneumonia due to COVID-19
• With SARS-Cov2 PCR RNA detection test, positive
• Severe ARDS
• PaO2/FiO2 \<150
• Leukocytes \< 800
• Chest TAC with pneumonia bilateral
• persistant fever
• increase 50% D-Dimer, respect to basal value
• Ferritin \> 1000
• SOFA \< 11
• Medical treatment during 48 hr according to de Institutional Medical center
• With knowledge of the patient and / or his relatives responsible that it is a rescue treatment, in experimental phase.

You may not qualify if:

• Pneumonia or ARDS caused by COVID-19, mild and moderate.
• More than three organic failures
• Expectations of survival less than 48 hr in the opinion of the treating service
• Pneumonia or SIRA not caused by COVID-19
• Advance will of the patient to refuse rescue or experimental treatment.

Sponsors & Collaborators

• Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran: lead

Study Sites (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, 14080, Mexico

RECRUITING

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Martin Iglesias, MD

CONTACT

+1 52 55 5580097509; iglesias@drmartiniglesias.com

Carlos A Aguilar-Salinas, MD

CONTACT

+1 52 55 54870900; caguilarsalinas@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Plastic surgeon

Model Details: Mesenchymal Stem Cell from umbilical cord allogenic from de bank laboratory, will be applied IV to 5 patients con pneumonia bilateral due to COVID 19, complicated with acute respiratory distress syndrome. The clinical, biochemical, inflammatory and immune changes will be described and compare against historical cases treated in the Instituto Nacional de Ciencias Medicas y Nutrición Salvador Zubirán

Study Record Dates

• First Submitted: May 30, 2020
• First Posted: June 4, 2020
• Study Start: May 1, 2020
• Primary Completion: April 30, 2021
• Study Completion: May 1, 2021
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)