NCT03807804

Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Healios K.K. · Industry
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Respiratory Distress Syndrome, Adult

Interventions

Type	Name	Description
BIOLOGICAL	HLCM051	HLCM051 is the stem cell product that can be mass-produced, being derived from adult adhesive stem cells that were taken from bone marrow of healthy unrelated donors from whom the informed consent was obtained, and proliferated ex vivo.

Timeline

• Start date: 2019-01-01
• Primary completion: 2021-12-14
• Completion: 2021-12-14
• First posted: 2019-01-17
• Last updated: 2024-01-17

Locations

29 sites across 1 country: Japan