NCT04602104 - A Clinical Study of Mesenchymal Stem Cell Exosomes Nebulizer for the Treatment of ARDS | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

November 30, 2020

Primary Completion Date

November 10, 2022

Study Completion Date

January 11, 2023

Conditions

Acute Respiratory Distress Syndrome

Interventions

BIOLOGICAL

low dose hMSC-Exos

basic treatment and 7 times aerosol inhalation of hMSC-Exos (2.0\*10\^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

BIOLOGICAL

medium dose hMSC-Exos

basic treatment and 7 times aerosol inhalation of hMSC-Exos (8.0\*10\^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

BIOLOGICAL

high dose hMSC-Exos

basic treatment and 7 times aerosol inhalation of hMSC-Exos (16.0\*10\^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

BIOLOGICAL

Dosage 1of hMSC-Exos

basic treatment and 7 times aerosol inhalation of hMSC-Exos (a quarter of MTD/day at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

BIOLOGICAL

Dosage 2 of hMSC-Exos

basic treatment and 7 times aerosol inhalation of hMSC-Exos (MTD/day at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

BIOLOGICAL

No hMSC-derived exosomes

basic treatment and 7 times aerosol inhalation of normal saline (at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

Trial Locations (1)

Ruijin Hospital, Medical School of Shanghai Jiaotong University, Shanghai

All Listed Sponsors

collaborator

Shanghai AbelZeta Ltd.

INDUSTRY

lead

Ruijin Hospital

OTHER