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

NCT03807804 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2024-01-17

No results posted yet for this study

Summary

The primary object of this clinical study is to investigate the efficacy of HLCM051 in patients with ARDS caused by pneumonitis.

Conditions

  • Respiratory Distress Syndrome, Adult

Interventions

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.

Sponsors & Collaborators

  • Healios K.K.

    lead INDUSTRY

Principal Investigators

  • Kazuya Ichikado, M.D., Ph.D. · Saiseikai Kumamoto Hospital

  • Satoru Hashimoto, M.D., Ph.D. · University Hospital, Kyoto Prefectural University of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2021-12-14
Completion
2021-12-14

Countries

  • Japan

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 NCT03807804 on ClinicalTrials.gov