Efficacy and Safety Study of HLCM051(MultiStem®) for Pneumonic Acute Respiratory Distress Syndrome
- Conditions
- Respiratory Distress Syndrome, Adult
- Interventions
- Biological: HLCM051
- Registration Number
- NCT03807804
- Lead Sponsor
- Healios K.K.
- 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)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description HLCM051 group【ARDS caused by COVID-19 cohort 】 HLCM051 * Patients will receive the standard therapy * A single, one-time dose of HLCM051 9.0×108 (±20%) cells are intravenously infused as a naturally dropped single dose over 30 to 60 minutes at the maximum infusion speed of 10 mL/minute HLCM051 group【ARDS caused by pneumonia cohort】 HLCM051 * Patients will receive the standard therapy * A single, one-time dose of HLCM051 9.0×108 (±20%) cells are intravenously infused as a naturally dropped single dose over 30 to 60 minutes at the maximum infusion speed of 10 mL/minute
- Primary Outcome Measures
Name Time Method Change from baseline in systolic blood pressure(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in systolic blood pressure(mmHg)
Change from baseline in basophils(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in basophils(%)
Change from baseline in alkaline phosphatase(ALP)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in alkaline phosphatase(ALP)(IU/L)
Change from baseline in blood urea nitrogen(BUN)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in blood urea nitrogen(BUN)(mg/dL)
Change from baseline in chloride(Cl)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in chloride(Cl)(mmol/L)
Change from baseline in uric blood(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in uric blood(- to \>= 4+)
Change from baseline in urinary sediment(RBC)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in urinary sediment(RBC)(/HPF)
Change from baseline in urinary sediment(Other)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in urinary sediment(Other)(/HPF)
Adverse events(ARDS caused by COVID-19 cohort) From informed consent to 180 days after administration of the investigational product The number and rate of adverse events
Change from baseline in pulse rate(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in pulse rate(beats/min)
Change from baseline in respiration(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in respiration(breath/min)
Change from baseline in body temperature(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in body temperature(C)
Change from baseline in hematocrit(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in hematocrit(%)
Ventilator-free days (VFD)(ARDS caused by pneumonia cohort) 28 days after administration of the investigational product VFD for 28 days after administration of the investigational product
Change from baseline in diastolic blood pressure(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in diastolic blood pressure(mmHg)
Change from baseline in oxygen saturation(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in oxygen saturation(%)
Change from baseline in red blood cell count(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in red blood cell count(/uL)
Change from baseline in hemoglobin(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in hemoglobin(g/dL)
Change from baseline in neutrophils(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in neutrophils(%)
Change from baseline in monocytes(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in monocytes(%)
Change from baseline in platelet count(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in platelet count(/uL)
Change from baseline in asparate aminotransferase(AST)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in asparate aminotransferase(AST)(IU/L)
Change from baseline in blood sugar(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in blood sugar(mg/dL)
Change from baseline in lymphocytes(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in lymphocytes(%)
Change from baseline in leukocyte count(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in leukocyte count(/uL)
Change from baseline in eosinophils(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in eosinophils(%)
Change from baseline in creatinine(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in creatinine(mg/dL)
Change from baseline in alanine aminotransferase(ALT)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in alanine aminotransferase(ALT)(IU/L)
Change from baseline in total bilirubin(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in total bilirubin(mg/dL)
Change from baseline in sodium(Na)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in sodium(Na)(mmol/L)
Change from baseline in potassium(K)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in potassium(K)(mmol/L)
Change from baseline in calcium(Ca)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in calcium(Ca)(mg/dL)
Change from baseline in urinary protein(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in urinary protein(- to \>= 4+)
Change from baseline in urinary sugar(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in urinary sugar(- to \>= 4+)
Change from baseline in urinary sediment(WBC)(ARDS caused by COVID-19 cohort) From screening to 180 days after administration of the investigational product Change from baseline in urinary sediment(WBC)(/HPF)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (29)
Investigational Site Number 025
🇯🇵Yokohama, Kanagawa, Japan
Investigational Site Number 029
🇯🇵Yokohama, Kanagawa, Japan
Investigational Site Number 018
🇯🇵Kashihara, Nara, Japan
Investigational Site Number 012
🇯🇵Hiroshima, Japan
Investigational Site Number 017
🇯🇵Takarazuka, Hyogo, Japan
Investigational Site Number 001
🇯🇵Kumamoto, Japan
Investigational Site Number 013
🇯🇵Kobe, Hyogo, Japan
Investigational Site Number 002
🇯🇵Kyoto, Japan
Investigational Site Number 006
🇯🇵Minato-Ku, Tokyo, Japan
Investigational Site Number 010
🇯🇵Kobe, Hyogo, Japan
Investigational Site Number 009
🇯🇵Itabashi-ku, Tokyo, Japan
Investigational Site Number 008
🇯🇵Shinjuku-Ku, Tokyo, Japan
Investigational Site Number 023
🇯🇵Shinjuku-Ku, Tokyo, Japan
Investigational Site Number 028
🇯🇵Nagoya, Aichi, Japan
Investigational Site Number 020
🇯🇵Toyoake, Aichi, Japan
Investigational Site Number 019
🇯🇵Ōgaki, Gifu, Japan
Investigational Site Number 007
🇯🇵Iizuka, Fukuoka, Japan
Investigational Site Number 027
🇯🇵Nagoya, Aichi, Japan
Investigational Site Number 005
🇯🇵Seto, Aichi, Japan
Investigational Site Number 003
🇯🇵Hirosaki, Aomori, Japan
Investigational Site Number 011
🇯🇵Sapporo, Hokkaido, Japan
Investigational Site Number 022
🇯🇵Ōtsu, Shiga, Japan
Investigational Site Number 014
🇯🇵Izumo, Shimane, Japan
Investigational Site Number 024
🇯🇵Bunkyō-Ku, Tokyo, Japan
Investigational Site Number 004
🇯🇵Shinagawa-Ku, Tokyo, Japan
Investigational Site Number 026
🇯🇵Suita, Osaka, Japan
Investigational Site Number 015
🇯🇵Nagasaki, Japan
Investigational Site Number 021
🇯🇵Chuo Ku, Tokyo, Japan
Investigational Site Number 016
🇯🇵Saga, Japan