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A Clinical Study of Mesenchymal Progenitor Cell Exosomes Nebulizer for the Treatment of Pulmonary Infection

NCT04544215 · Status: SUSPENDED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-22

No results posted yet for this study

Summary

Evaluate the efficacy and safety of haMPC-Exos treatment with pulmonary infection caused by gram-negative bacilli resistant to carbapenems.

Conditions

  • Drug-resistant

Interventions

BIOLOGICAL

Dosage 1 of MPCs-derived exosomes

7 times aerosol inhalation of MPCs-derived exosomes (8.0\*108 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7).

BIOLOGICAL

Dosage 2 of MPCs-derived exosomes

7 times aerosol inhalation of MPCs-derived exosomes (16.0\*108 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7).

BIOLOGICAL

No MPCs-derived exosomes

No aerosol inhalation of MPCs-derived exosomes

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
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-01
Primary Completion
2024-12-01
Completion
2025-03-01

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 NCT04544215 on ClinicalTrials.gov