MSC-based Therapy in COVID-19-associated Acute Respiratory Distress Syndrome

Mesenchymal Stromal Cell-based Therapy for COVID-19-associated Acute Respiratory Distress Syndrome: a Pilot Clinical Study

Considering the potential of mesenchymal stromal cells (MSCs) in the treatment of lung injuries by COVID-19, this pilot clinical trial evaluates the safety and potential efficacy of the cell therapy, administered intravenously, in patients with pneumonia associated with COVID-19-associated acute respiratory distress syndrome.

Study Overview

• Status: Unknown
• Conditions: Covid19; ARDS, Human
• Intervention / Treatment: Other: Mesenchymal stromal cell-based therapy

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Bruno SF Souza, MD PHD; Phone Number: +557132816455; Email: bruno.souza@hsr.com.br

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 41253-190
      • Recruiting
      • Hospital Sao Rafael
      • Contact: Andre Gobatto, MD PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Clinical diagnosis of COVID-19 confirmed by RT-PCR;
• Thorax CT image suggestive of viral pneumonia;
• Respiratory failure (SaO2 <93% with O2 at 5L / min)
• Tracheal intubation (first 48 h);

Exclusion Criteria:

• Pregnancy or breastfeeding;
• Patients with a history of cancer, chemotherapy in the past 2 years;
• Life expectancy less than 6 months or in exclusive palliative care;
• Severe liver failure, with Child-Pugh score> 12;
• High probability of death in the following 48 h;
• Previous renal failure: patients who were already on dialysis or patients with RFG <30ml / min / 1.73 m2;
• Clinical or radiological suspicion of tuberculosis and bacterial pneumonia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Patients will receive standard care.
Experimental: MSC - low dose (2.5x10ˆ7); Patients will receive standard care plus cell therapy.	Other: Mesenchymal stromal cell-based therapy; Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)
Experimental: MSC - intermediate dose (5x10ˆ7); Patients will receive standard care plus cell therapy.	Other: Mesenchymal stromal cell-based therapy; Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)
Experimental: MSC - high dose (10x10ˆ7); Patients will receive standard care plus cell therapy.	Other: Mesenchymal stromal cell-based therapy; Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Intrahospital mortality	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in the ICU and Hospital		28 days
Days without mechanical ventilation in 28 days		28 days
PaO2 / FiO2 ratio		Day 1, Day 2 and Day 7 after cell infusion
Incidence of secondary infections		28 days
Incidence of adverse events		28 days
Quantification of inflammatory response markers	Exploratory evaluation of changes from baseline (percentage) in serum levels of CRP, LDH, Ferritin levels, a panel of cytokines, chemokines immune cell populations by flow cytometry	Day 1, Day 3 and Day 7 after cell infusion

Collaborators and Investigators

• Sponsor: D'Or Institute for Research and Education

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Anticipated): September 30, 2020
• Study Completion (Anticipated): October 31, 2020

Study Registration Dates

• First Submitted: July 31, 2020
• First Submitted That Met QC Criteria: August 22, 2020
• First Posted (Actual): August 25, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: PCL02/2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No