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

NCT04366063 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-04-30

No results posted yet for this study

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

Interventions

BIOLOGICAL

Cell therapy protocol 1

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.

BIOLOGICAL

Cell therapy protocol 2

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.

Sponsors & Collaborators

  • Tehran University of Medical Sciences

    collaborator OTHER

  • Shahid Beheshti University of Medical Sciences

    collaborator OTHER

  • Royan Institute

    lead OTHER_GOV

Principal Investigators

  • Abdol Hossein Shahverdi · Royan Institute

  • Hossein Baharvand, Professor · Department of Stem Cells Biology and Technology, Cell Science Research Center, Royan Institute for Stem Cells Biology & Technology, Iran

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-05
Primary Completion
2020-06-06
Completion
2020-12-10

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04366063 on ClinicalTrials.gov