Mesenchymal Stem Cell Therapy for SARS-CoV-2-related Acute Respiratory Distress Syndrome

NCT04366063 | Unknown Phase 2 DMC

• 2 other identifiers: 991919IRCT20200217046526N2
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Acute Respiratory Distress Syndrome (ARDS) is the major cause of death in the COVID-19 pandemic. In this trial, the safety and efficacy of Mesenchymal Stem Cells (MSC) for the treatment of ARDS in COVID-19 patients will be assessed.

Conditions

Covid-19

Keywords

COVID-19; Acute Respiratory Distress Syndrome; 2019 Novel Coronavirus Pneumonia

Outcome Measures

Primary Outcomes (2)

• Adverse events assessment

  Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  From baseline to day 28

• Blood oxygen saturation

  Evaluation of Pneumonia Improvement

  From baseline to day 14

Secondary Outcomes (4)

• Intensive care unit-free days

  Up to day 8

• Clinical symptoms

  From baseline to day 14

• Respiratory efficacy

  From baseline to day 7

• Biomarkers concentrations in plasma

  At baseline, 7, 14, 28 days after the first intervention

Study Arms (3)

Two MSC infusion

EXPERIMENTAL

Intervention Group1(n=20). Patients will receive two doses of MSCs 100×10e6 (±10%) intravenously plus Conventional treatment.

Biological: Cell therapy protocol 1

Two MSC infusion Plus two EVs infusion

EXPERIMENTAL

Intervention Group 2 (n=20). Patients will receive two doses of MSCs 100×10e6 (±10%), intravenously plus two doses of EVs plus Conventional treatment

Biological: Cell therapy protocol 2

Control

NO INTERVENTION

Control (n=20). Patients will conventional therapy for virus treatment and supportive care for ARDS will be used as control.

Interventions

Cell therapy protocol 1 BIOLOGICAL

Cell therapy protocol 1(n=20). Patients will receive two doses of MSCs 100×10e6 (±10%) at Day 0 and Day 2 plus Conventional treatment.

Two MSC infusion

Cell therapy protocol 2 BIOLOGICAL

Patients will receive two doses of MSCs 100×10e6 (±10%)at Day 0 and Day 2, intravenously plus two doses of EVs at Day 4 and Day 6 plus conventional treatment.

Two MSC infusion Plus two EVs infusion

Eligibility Criteria

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

You may qualify if:

• Confirmation of 2019-nCoV infection by RT-PCR
• Diagnosis of ARDS according to the Berlin definition of ARDS
• Requiring supplemental oxygen
• Pneumonia that is judged by chest radiograph or CT
• PaO2/oxygen absorption concentration (FiO2) ≤ 300MMHG
• Pulmonary imaging shows that the focused progress \> 50% in 24-48 hours
• Mild to Moderate 2019-nCoV pneumonia/ stay in the ICU \<48 hours
• SOFA score between 2-3 point

You may not qualify if:

• Severe allergies or allergies after 1st injection to stem cell preparations and their components
• Patients with a malignant tumor, other serious systemic diseases, and psychosis
• Co-Infection of HIV, tuberculosis, influenza virus, adenovirus, and other respiratory infection viruses
• Patients with a previous history of pulmonary embolism
• Be thought by researchers to be inappropriate to participate in this clinical study (Expected deaths within 48 hours, uncontrolled infections)
• Liver or kidney SOFA score of more than 3 points; combined with other organ failures (need organ support), Stage 4 severe chronic kidney disease or requiring dialysis (i.e. estimated glomerular filtration rate (eGFR) \< 30)
• Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia
• Continuous use of immunosuppressive agents or organ transplants in the past 6 months
• In vitro life support (ECMO, ECCO2R, RRT)
• Pregnant or lactating women
• Uncontrolled underlying disease

Sponsors & Collaborators

• Royan Institute: lead
• Tehran University of Medical Sciences: collaborator
• Shahid Beheshti University of Medical Sciences: collaborator

Study Sites (1)

Royan Institute

Tehran, 16635148, Iran

RECRUITING

MeSH Terms

Conditions

COVID-19; Respiratory Distress Syndrome

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; Respiration Disorders

Study Officials

• Abdol Hossein Shahverdi

  Royan Institute

  STUDY CHAIR

• Hossein Baharvand, Professor

  Department of Stem Cells Biology and Technology, Cell Science Research Center, Royan Institute for Stem Cells Biology & Technology, Iran

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Masoumeh Nouri

CONTACT

00982127635512; masoume.nouri2002@gmail.com

Hoda Madani

CONTACT

00982122518388; hoda62_m@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2020
• First Posted: April 28, 2020
• Study Start: April 5, 2020
• Primary Completion: June 6, 2020
• Study Completion: December 10, 2020
• Last Updated: April 30, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 6 months after publication
• Access Criteria: Researchers and clinicians

Locations

IR (1)