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Respiratory Distress Syndrome, AdultPhase 2ONE-BRIDGENCT03807804

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

A Phase 2 study testing HLCM051 in people with Respiratory Distress Syndrome, Adult, run by Healios K.K. at 29 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Respiratory Distress Syndrome, Adult
What is being tested?
HLCM051
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
35 participants
Where
29 sitesJapan
Study dates
1 Jan 2019to 14 Dec 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Provision of informed consent by the patient or his/her legal representative in case the patient is incapable of giving consent due to sedation etc
  • Male or female aged 20 to 90 years at informed consent (Asians only)
  • Patients with ARDS caused by pneumonia of those who were diagnosed as having ARDS according to the Berlin Definition
  • Patients who are confirmed to have the following findings in the Berlin Definition within the same 24 hours 1)PaO2/FiO2 (P/F) ratio ≤ 300 mmHg with positive end-expiratory pressure (PEEP) ≥ 5 cmH2O 2)Bilateral opacities on chest X-ray or CT (not fully explained by effusions, lobar/lung collapse, and nodular shadow) 3)Respiratory failure that cannot be explained by cardiac failure and fluid overload
  • Patients who underwent chest high-resolution computed tomography (HRCT)
  • Patients with HRCT score ≥211 according to the abbreviated HRCT scoring system
Show all 23Show fewer
  • Patients with APACHE II score <27 at the diagnosis of ARDS
  • Patients who underwent artificial respiration with intubation
  • Patients who can start receiving the investigational product within 72 hours (3 days) after the diagnosis of ARDS
  • Patients whose condition is expected to be stable for at least 4 hours after initiating investigational product administration "Stable" means the condition where there is no need for significant sustained increase in FiO2 or PEEP and the supportive care for the cardiovascular system is not required (e.g. an increase in the dose of norepinephrine or epinephrine by ≥0.1 mcg/kg/min or an increase in the dose of inotropic agent or vasopressor by ≥20% besides norepinephrine and epinephrine for blood pressure control)
  • Women who are neither pregnant, breastfeeding, planning to become pregnant during the study period. Women of childbearing potential must agree on the use of appropriate contraceptive methods under the guidance of investigators through the completion of the clinical study
  • Male patients who have female partners of childbearing potential must agree on the use of appropriate contraceptive methods under the guidance of investigators through the completion of the clinical study
  • Provision of informed consent by the patient or his/her legal representative in case the patient is incapable of giving consent due to sedation etc.
  • Male or female aged 20 to 70 years at informed consent (Asians only)
  • Patients tested positive for COVID-19
  • Patients with ARDS caused by COVID-19 of those who were diagnosed as having ARDS according to the Berlin Definition
  • Patients who are confirmed to have the following findings in the Berlin Definition within the same 24 hours 1)PaO2/FiO2 (P/F) ratio ≤ 300 mmHg with positive end-expiratory pressure (PEEP) ≥ 5 cmH2O 2)Bilateral opacities on chest X-ray or CT (not fully explained by effusions, lobar/lung collapse, and nodular shadow) 3)Respiratory failure that cannot be explained by cardiac failure and fluid overload
  • Patients who underwent Chest X-ray, chest CT or high-resolution computed tomography (HRCT) as far as possible
  • Patients with APACHE II score <27 at the diagnosis of ARDS
  • Patients who underwent artificial respiration with intubation
  • Patients who can start receiving the investigational product within 72 hours (3 days) after the diagnosis of ARDS
  • Women who are neither pregnant, breastfeeding, planning to become pregnant during the study period. Women of childbearing potential must agree on the use of appropriate contraceptive methods under the guidance of investigators through the completion of the clinical study
  • Male patients who have female partners of childbearing potential must agree on the use of appropriate contraceptive methods under the guidance of investigators through the completion of the clinical study

Who cannot join

  • Patients without life expectancy of 48 hours
  • Patients who are under artificial dialysis at screening
  • Patients whose life expectancy is <6 months because of complications at screening
  • Patients under ventilator at home due to chronic respiratory disease
  • Patients who have been on mechanical ventilation for ≥ 1 week
  • Patients with obvious honeycomb lung at screening consistent with pre-existing late-stage interstitial lung disease
Show all 49Show fewer
  • Patients with clinically evident findings consistent with diffuse alveolar hemorrhage
  • Patients with chronic respiratory disease that requires continuous domiciliary oxygen therapy
  • Patients with severe COPD (stage III or severe according to the GOLD Classification)
  • Patients with chronic pulmonary hypertension (class III or IV according to the World Health Organization Classification of Functional Status of Patients With Pulmonary Hypertension)
  • Patients with a history of lung lobectomy, single-lung pneumonectomy or pulmonary transplantation
  • Patients who are appropriate to be treated with extracorporeal membrane oxygenation (ECMO) at screening
  • Patients who were resuscitated after cardio-respiratory arrest
  • Patients with a history of ST-segment elevation myocardial infarction within 6 months before informed consent
  • Patients with mean arterial (blood) pressure (MAP) <60 mmHg despite treatment with one or more vasopressor or cardiotonic agent
  • Patients with severe chronic liver disease (Child-Pugh >10)
  • Patients with a history of transplantation with autologous or allogeneic, bone marrow or peripheral stem cells for other purposes than the treatment of hematological tumor
  • Patients with malignancy requiring treatment at screening
  • Patients infected with human immunodeficiency virus (HIV)
  • Patients with a history of acute allergic reaction to the preparations derived from human tissues, bovine or swine materials, and those who refuse the use of biological products due to religious reasons
  • Patients for whom ARDS is not judged as the chief complaint by the investigator (sub-investigator) based on clinical findings
  • Patients who received other investigational drugs or products within 30 days prior to informed consent
  • Patients who are participating or planned to participate in other clinical studies (except for observational clinical researches that do not require intervention) during this clinical study
  • Patients who are inappropriate to participate in this clinical study because of significant complications (such as pneumothorax ) or psychiatric disorders as judged by the investigator
  • Patients who is suspected SARS-CoV-2 infection
  • Patients without life expectancy of 48 hours
  • Patients who are under artificial dialysis at screening
  • Patients whose life expectancy is <6 months because of complications at screening
  • Patients under ventilator at home due to chronic respiratory disease
  • Patients who have been on mechanical ventilation for ≥ 1 week
  • Patients with obvious honeycomb lung at screening consistent with pre-existing late-stage interstitial lung disease
  • Patients with clinically evident findings consistent with diffuse alveolar hemorrhage
  • Patients with chronic respiratory disease that requires continuous domiciliary oxygen therapy
  • Patients with severe COPD (stage III or severe according to the GOLD Classification)
  • Patients with chronic pulmonary hypertension (class III or IV according to the World Health Organization Classification of Functional Status of Patients With Pulmonary Hypertension)
  • Patients with a history of lung lobectomy, single-lung pneumonectomy or pulmonary transplantation
  • Patients who are appropriate to be treated with extracorporeal membrane oxygenation (ECMO) at screening
  • Patients who were resuscitated after cardio-respiratory arrest
  • Patients with a history of ST-segment elevation myocardial infarction within 6 months before informed consent
  • Patients with mean arterial (blood) pressure (MAP) <60 mmHg despite treatment with one or more vasopressor or cardiotonic agent
  • Patients with severe chronic liver disease (Child-Pugh >10)
  • Patients with a history of transplantation with autologous or allogeneic, bone marrow or peripheral stem cells for other purposes than the treatment of hematological tumor
  • Patients with malignancy requiring treatment at screening
  • Patients infected with human immunodeficiency virus (HIV)
  • Patients with a history of acute allergic reaction to the preparations derived from human tissues, bovine or swine materials, and those who refuse the use of biological products due to religious reasons
  • Patients for whom ARDS is not judged as the chief complaint by the investigator (sub-investigator) based on clinical findings
  • Patients who have used other investigational drugs or products within 30 days before informed consent (excluding other investigational drugs or products used for the purpose of treating COVID-19)
  • Patients who are participating or planning to participate in other clinical studies during the study period (excluding other clinical studies, clinical researches and observational clinical researches that do not require intervention for the purpose of treating COVID-19)
  • Patients who are inappropriate to participate in this clinical study because of significant complications (such as pneumothorax ) or psychiatric disorders as judged by the investigator

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

Japan29 sites

  • Investigational Site Number 024

    Bunkyō-Ku, Tokyo

  • Investigational Site Number 021

    Chuo Ku, Tokyo

  • Investigational Site Number 003

    Hirosaki, Aomori

  • Investigational Site Number 012

    Hiroshima

  • Investigational Site Number 007

    Iizuka, Fukuoka

  • Investigational Site Number 014

    Izumo, Shimane

  • Investigational Site Number 018

    Kashihara, Nara

  • Investigational Site Number 010

    Kobe, Hyōgo

  • Investigational Site Number 013

    Kobe, Hyōgo

  • Investigational Site Number 001

    Kumamoto

  • Investigational Site Number 002

    Kyoto

  • Investigational Site Number 006

    Minato-Ku, Tokyo

  • Investigational Site Number 015

    Nagasaki

  • Investigational Site Number 027

    Nagoya, Aichi-ken

  • Investigational Site Number 028

    Nagoya, Aichi-ken

  • Investigational Site Number 019

    Ōgaki, Gifu

  • Investigational Site Number 022

    Ōtsu, Shiga

  • Investigational Site Number 016

    Saga

  • Investigational Site Number 011

    Sapporo, Hokkaido

  • Investigational Site Number 005

    Seto, Aichi-ken

  • Investigational Site Number 004

    Shinagawa-Ku, Tokyo

  • Investigational Site Number 008

    Shinjuku-Ku, Tokyo

  • Investigational Site Number 023

    Shinjuku-Ku, Tokyo

  • Investigational Site Number 026

    Suita, Osaka

  • Investigational Site Number 009

    tabashi City, Tokyo

  • Investigational Site Number 017

    Takarazuka, Hyōgo

  • Investigational Site Number 020

    Toyoake, Aichi-ken

  • Investigational Site Number 025

    Yokohama, Kanagawa

  • Investigational Site Number 029

    Yokohama, Kanagawa

Other trials in Japan

About this study

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

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

Read the 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)

Being tested
HLCM051
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HLCM051Biological

    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.

Study groups in NCT03807804
Study groupRoleWhat they receive
HLCM051 group【ARDS caused by pneumonia cohort】Experimental* 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
Receives: Biological: HLCM051
Standard treatment group【ARDS caused by pneumonia cohort】No intervention•Patients will receive the standard therapy
HLCM051 group【ARDS caused by COVID-19 cohort 】Experimental* 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
Receives: Biological: HLCM051

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Ventilator-free days (VFD)(ARDS caused by pneumonia cohort)

    VFD for 28 days after administration of the investigational product

    Measured: 28 days after administration of the investigational product

  2. Adverse events(ARDS caused by COVID-19 cohort)

    The number and rate of adverse events

    Measured: From informed consent to 180 days after administration of the investigational product

  3. Change from baseline in systolic blood pressure(ARDS caused by COVID-19 cohort)

    Change from baseline in systolic blood pressure(mmHg)

    Measured: From screening to 180 days after administration of the investigational product

  4. Change from baseline in diastolic blood pressure(ARDS caused by COVID-19 cohort)

    Change from baseline in diastolic blood pressure(mmHg)

    Measured: From screening to 180 days after administration of the investigational product

  5. Change from baseline in pulse rate(ARDS caused by COVID-19 cohort)

    Change from baseline in pulse rate(beats/min)

    Measured: From screening to 180 days after administration of the investigational product

  6. Change from baseline in respiration(ARDS caused by COVID-19 cohort)

    Change from baseline in respiration(breath/min)

    Measured: From screening to 180 days after administration of the investigational product

  7. Change from baseline in oxygen saturation(ARDS caused by COVID-19 cohort)

    Change from baseline in oxygen saturation(%)

    Measured: From screening to 180 days after administration of the investigational product

  8. Change from baseline in body temperature(ARDS caused by COVID-19 cohort)

    Change from baseline in body temperature(C)

    Measured: From screening to 180 days after administration of the investigational product

  9. Change from baseline in red blood cell count(ARDS caused by COVID-19 cohort)

    Change from baseline in red blood cell count(/uL)

    Measured: From screening to 180 days after administration of the investigational product

  10. Change from baseline in hemoglobin(ARDS caused by COVID-19 cohort)

    Change from baseline in hemoglobin(g/dL)

    Measured: From screening to 180 days after administration of the investigational product

  11. Change from baseline in hematocrit(ARDS caused by COVID-19 cohort)

    Change from baseline in hematocrit(%)

    Measured: From screening to 180 days after administration of the investigational product

  12. Change from baseline in leukocyte count(ARDS caused by COVID-19 cohort)

    Change from baseline in leukocyte count(/uL)

    Measured: From screening to 180 days after administration of the investigational product

  13. Change from baseline in neutrophils(ARDS caused by COVID-19 cohort)

    Change from baseline in neutrophils(%)

    Measured: From screening to 180 days after administration of the investigational product

  14. Change from baseline in eosinophils(ARDS caused by COVID-19 cohort)

    Change from baseline in eosinophils(%)

    Measured: From screening to 180 days after administration of the investigational product

  15. Change from baseline in basophils(ARDS caused by COVID-19 cohort)

    Change from baseline in basophils(%)

    Measured: From screening to 180 days after administration of the investigational product

  16. Change from baseline in lymphocytes(ARDS caused by COVID-19 cohort)

    Change from baseline in lymphocytes(%)

    Measured: From screening to 180 days after administration of the investigational product

  17. Change from baseline in monocytes(ARDS caused by COVID-19 cohort)

    Change from baseline in monocytes(%)

    Measured: From screening to 180 days after administration of the investigational product

  18. Change from baseline in platelet count(ARDS caused by COVID-19 cohort)

    Change from baseline in platelet count(/uL)

    Measured: From screening to 180 days after administration of the investigational product

  19. Change from baseline in asparate aminotransferase(AST)(ARDS caused by COVID-19 cohort)

    Change from baseline in asparate aminotransferase(AST)(IU/L)

    Measured: From screening to 180 days after administration of the investigational product

  20. Change from baseline in alanine aminotransferase(ALT)(ARDS caused by COVID-19 cohort)

    Change from baseline in alanine aminotransferase(ALT)(IU/L)

    Measured: From screening to 180 days after administration of the investigational product

  21. Change from baseline in alkaline phosphatase(ALP)(ARDS caused by COVID-19 cohort)

    Change from baseline in alkaline phosphatase(ALP)(IU/L)

    Measured: From screening to 180 days after administration of the investigational product

  22. Change from baseline in total bilirubin(ARDS caused by COVID-19 cohort)

    Change from baseline in total bilirubin(mg/dL)

    Measured: From screening to 180 days after administration of the investigational product

  23. Change from baseline in blood urea nitrogen(BUN)(ARDS caused by COVID-19 cohort)

    Change from baseline in blood urea nitrogen(BUN)(mg/dL)

    Measured: From screening to 180 days after administration of the investigational product

  24. Change from baseline in creatinine(ARDS caused by COVID-19 cohort)

    Change from baseline in creatinine(mg/dL)

    Measured: From screening to 180 days after administration of the investigational product

  25. Change from baseline in sodium(Na)(ARDS caused by COVID-19 cohort)

    Change from baseline in sodium(Na)(mmol/L)

    Measured: From screening to 180 days after administration of the investigational product

  26. Change from baseline in potassium(K)(ARDS caused by COVID-19 cohort)

    Change from baseline in potassium(K)(mmol/L)

    Measured: From screening to 180 days after administration of the investigational product

  27. Change from baseline in chloride(Cl)(ARDS caused by COVID-19 cohort)

    Change from baseline in chloride(Cl)(mmol/L)

    Measured: From screening to 180 days after administration of the investigational product

  28. Change from baseline in calcium(Ca)(ARDS caused by COVID-19 cohort)

    Change from baseline in calcium(Ca)(mg/dL)

    Measured: From screening to 180 days after administration of the investigational product

  29. Change from baseline in blood sugar(ARDS caused by COVID-19 cohort)

    Change from baseline in blood sugar(mg/dL)

    Measured: From screening to 180 days after administration of the investigational product

  30. Change from baseline in urinary protein(ARDS caused by COVID-19 cohort)

    Change from baseline in urinary protein(- to >= 4+)

    Measured: From screening to 180 days after administration of the investigational product

  31. Change from baseline in urinary sugar(ARDS caused by COVID-19 cohort)

    Change from baseline in urinary sugar(- to >= 4+)

    Measured: From screening to 180 days after administration of the investigational product

  32. Change from baseline in uric blood(ARDS caused by COVID-19 cohort)

    Change from baseline in uric blood(- to >= 4+)

    Measured: From screening to 180 days after administration of the investigational product

  33. Change from baseline in urinary sediment(RBC)(ARDS caused by COVID-19 cohort)

    Change from baseline in urinary sediment(RBC)(/HPF)

    Measured: From screening to 180 days after administration of the investigational product

  34. Change from baseline in urinary sediment(WBC)(ARDS caused by COVID-19 cohort)

    Change from baseline in urinary sediment(WBC)(/HPF)

    Measured: From screening to 180 days after administration of the investigational product

  35. Change from baseline in urinary sediment(Other)(ARDS caused by COVID-19 cohort)

    Change from baseline in urinary sediment(Other)(/HPF)

    Measured: From screening to 180 days after administration of the investigational product

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2019
  2. Study start1 Jan 2019
  3. Primary completion14 Dec 2021
  4. Study completion14 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
【ARDS caused by pneumonia cohort】Parallel Assignment 【ARDS caused by COVID-19 cohort】Single group
Masking
None (open label)
Enrolment
35 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03807804
Sponsor's protocol ID
B04-02
Acronym
ONE-BRIDGE
Status last verified
Apr 2021
First submitted
8 Jan 2019
Last updated
17 Jan 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ichikado K, Kotani T, Kondoh Y, Imanaka H, Johkoh T, Fujimoto K, Nunomiya S, Kawayama T, Sawada M, Jenkins E, Tasaka S, Hashimoto S. Clinical efficacy and safety of multipotent adult progenitor cells (invimestrocel) for acute respiratory distress syndrome (ARDS) caused by pneumonia: a randomized, open-label, standard therapy-controlled, phase 2 multicenter study (ONE-BRIDGE). Stem Cell Res Ther. 2023 Aug 22;14(1):217. doi: 10.1186/s13287-023-03451-z.

    PubMed 37608287

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HLCM051 in people with Respiratory Distress Syndrome, Adult, run by Healios K.K. at 29 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 49 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ventilator-free days (VFD)(ARDS caused by pneumonia cohort) (time frame: 28 days after administration of the investigational product). The study lists 35 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03807804, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2024.

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