Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT03807804
Status:
COMPLETED
Last Update Posted:
2024-01-17
First Post:
2019-01-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome
Sponsor:
Healios K.K.
Organization:
Study Overview
Official Title:
An Open-label, Standard Therapy as a Controlled, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of HLCM051(MultiStem) in Patients With Acute Respiratory Distress Syndrome (ARDS) Caused by Pneumonitis
Status:
COMPLETED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ONE-BRIDGE
Brief Summary:
The primary object of this clinical study is to investigate the efficacy of HLCM051 in patients with ARDS caused by pneumonitis.
Detailed Description:
The objectives of this clinical study are as follows(ARDS caused by pneumonia cohort):
1. Primary objective To investigate the efficacy of HLCM051 in patients with ARDS caused by pneumonia
2. Secondary objective To confirm the safety of HLCM05 in patients with ARDS caused by pneumonia
3. Exploratory objective To investigate changes of biomarkers in patients with ARDS caused by pneumonia
The number of patients enrolled is 30 (20 patient in the HLCM051 group and 10 patients in the standard therapy group)
The objectives of this clinical study is as follows(ARDS caused by COVID-19 cohort):
1\. Exploratory objective To investigate the safety and the efficacy of HLCM051 in patients with ARDS caused by SARS-Cov-2 infection
The number of patients enrolled is Approximately 5 (the HLCM051 group only)
1. Primary objective To investigate the efficacy of HLCM051 in patients with ARDS caused by pneumonia
2. Secondary objective To confirm the safety of HLCM05 in patients with ARDS caused by pneumonia
3. Exploratory objective To investigate changes of biomarkers in patients with ARDS caused by pneumonia
The number of patients enrolled is 30 (20 patient in the HLCM051 group and 10 patients in the standard therapy group)
The objectives of this clinical study is as follows(ARDS caused by COVID-19 cohort):
1\. Exploratory objective To investigate the safety and the efficacy of HLCM051 in patients with ARDS caused by SARS-Cov-2 infection
The number of patients enrolled is Approximately 5 (the HLCM051 group only)
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: