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Mesenchymal Stem Cells for The Treatment of Acute Respiratory Distress Syndrome (ARDS)

NCT04347967 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2023-12-04

No results posted yet for this study

Summary

The clinical study with UMC119-06 is designed to investigate the safety in patients with moderate acute respiratory distress syndrome ("ARDS"). This will be a dose escalation, open-label, single-center study in adult with ARDS. UMC119-06 is ex vivo cultured human umbilical cord derived mensenchymal stem cells (hUC-MSCs) product which is intended for treatment of ARDS.

Conditions

  • Acute Respiratory Distress Syndrome

Interventions

BIOLOGICAL

UMC119-06

Cohort 1: Low does of UMC119-06；Cohort 2: Medium does of UMC119- 06；Cohort 3: High does of UMC119-06

Sponsors & Collaborators

  • Meridigen Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-01
Primary Completion
2024-09-30
Completion
2025-09-30
FDA Drug
Yes

Countries

  • Taiwan

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 NCT04347967 on ClinicalTrials.gov