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A Clinical Study of Mesenchymal Stem Cell Exosomes Nebulizer for the Treatment of ARDS

NCT04602104 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-07-22

No results posted yet for this study

Summary

To evaluate allogeneic human mesenchymal stem cell exosomes (hMSC-Exos) in the treatment of acute respiratory distress syndrome (ARDS)

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)

Sponsors & Collaborators

  • Shanghai AbelZeta Ltd.

    collaborator INDUSTRY

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2020-11-30
Primary Completion
2022-11-10
Completion
2023-01-11

Countries

  • China

Study Locations

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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 NCT04602104 on ClinicalTrials.gov