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Mesenchymal Stem Cells for The Treatment of Acute Respiratory Distress Syndrome (ARDS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04347967
Recruitment Status : Not yet recruiting
First Posted : April 15, 2020
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Meridigen Biotech Co., Ltd.

Brief Summary:
The clinical study with UMC119-06 is designed to investigate the safety in patients with moderate acute respiratory distress syndrome ("ARDS"). This will be a dose escalation, open-label, single-center study in adult with ARDS. UMC119-06 is ex vivo cultured human umbilical cord derived mensenchymal stem cells (hUC-MSCs) product which is intended for treatment of ARDS.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Biological: UMC119-06 Phase 1

Detailed Description:

ARDS, a noncardiogenic respiratory disease, is characterized by progressive hypoxemia and respiratory distress, associated with explosive acute inflammation and alveolar edema. ARDS occurs in all age group of patients, where mortality rates increase in advancing age.

In animal studies of ARDS, mensenchymal stem cells (MSCs) can attenuate lipopolysaccharides (LPS)-induced lung injury and pulmonary permeability edema through modulating the inflammatory. These findings show that MSCs may improve the clinical outcomes and prognosis of ARDS patient. Meridigen is developing UMC119-06, human umbilical cord-derived MSCs, for the treatment of ARDS. The purpose of this study is to assess the safety of UMC119-06 in patients with ARDS.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Safety and Tolerability After Intravenous Infusion of UMC119-06 in Subjects With Acute Respiratory Distress Syndrome (ARDS).
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2023


Arm Intervention/treatment
Experimental: UMC119-06
Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.
Biological: UMC119-06
Cohort 1: Low does of UMC119-06;Cohort 2: Medium does of UMC119- 06;Cohort 3: High does of UMC119-06




Primary Outcome Measures :
  1. The incidence and frequency of adverse events related to administration of UMC119-06. [ Time Frame: 3 months from the day of administration ]
    Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to AEs.


Secondary Outcome Measures :
  1. Changes in mortality status [ Time Frame: 15 months from the day of administration. ]
    Improvement in mortality status.

  2. Ventilator Free Days (VFD) [ Time Frame: 28 days from the day of administration ]
    Improvement in clinical function as assessed by Ventilator Free Days (VFD).

  3. Change in Oxygenation Index (OI) [ Time Frame: 7 days or discharge from ICU after the day of administration ]
    Improvement in clinical function as assessed by change in Oxygenation Index (OI).

  4. Change in Lung Injury Score (LIS) [ Time Frame: 7 days or discharge from ICU after the day of administration ]
    Improvement in clinical function as assessed by change in Lung Injury Score (LIS), 0-16 points, severity increasing with higher points.

  5. Change in positive end-expiratory pressure (PEEP) [ Time Frame: 7 days or discharge from ICU after the day of administration ]
    Improvement in clinical function as assessed by change in positive end-expiratory pressure (PEEP).

  6. Change in Lung Static Compliance [ Time Frame: 7 days or discharge from ICU after the day of administration ]
    Improvement in clinical function as assessed by change in Lung Static Compliance

  7. Change in acute physiology and chronic health evaluation score (APACHE II) [ Time Frame: 7 days from the day of administration ]
    Improvement in clinical function as assessed by change in acute physiology and chronic health evaluation score (APACHE II), higher scores correspond to more severe disease and a higher risk of death.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects of age ≥ 20 years and ≤ 85 years.
  • Subject has a diagnosis of moderate ARDS according to the Berlin definition of ARDS:

    1. No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
    2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph.
    3. Hypoxemia: PaO2/ FiO2 > 100 mmHg to ≤ 200 mmHg with PEEP ≥ 5 cm H2O.
    4. The time of onset of ARDS is when all of the specified ARDS criteria (2a-c) are met.
  • Patient is intubated and mechanically ventilated.
  • Subjects who had an onset of ARDS within 72 to 120 hours before start of treatment.
  • Subjects with body weight between 40 to 90 kg.
  • No decompensated heart failure.
  • Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided.
  • Women of child-bearing potential should have a negative serum pregnancy test prior to administration of investigational product., UNLESS they meet the following criteria:

    1. Post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum Follicle Stimulating Hormone (FSH) levels > 40 mIU/ml, OR;
    2. 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy.

Exclusion Criteria:

  • Greater than 72 hours since first meeting ARDS criteria per the Berlin definition.
  • No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol.
  • Expected life < 3 months from other cause than the respiratory failure.
  • Subject is receiving extra-corporeal membrane oxygenation, high-frequency oscillatory ventilation or any form of extra-corporeal lung support.
  • Subjects with history of any type of malignancy.
  • Major trauma in the prior 5 days.
  • Subjects with major surgery (body organs that require anesthesia, such as tumor removal, open chest, heart surgery, abdominal surgery, intracranial surgery, or normal surgery for more than 3 hours, etc.) within previous 14 days.
  • Subjects who are pregnant (or plan to become pregnant within 3 months of investigational product treatment) or lactating.
  • Subjects who have a significant concomitant illness as judged by principal investigator (PI).
  • Subjects who have significant abnormal laboratory tests at screening:

    1. >5 × upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST).
    2. >3 × upper limit of normal for total bilirubin.
    3. >2 × upper limit of normal for serum creatinine.
  • Subjects with known human immunodeficiency virus infection or who are immune compromised.
  • Subjects who are unable to return for follow-up visits for clinical evaluation, laboratory studies, or imaging evaluation.
  • Subjects with a history of severe allergic or anaphylactic reactions.
  • Subjects with known allergy or hypersensitivity to any component of the formulation (normal saline and human serum albumin).
  • Subjects who have participated in another clinical study of new investigational therapies or have received an investigational therapy within the 12 weeks before study drug administration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04347967


Contacts
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Contact: Mandy Li +886-2-2627-5175 ext 19933 Mandy.Li@meridigen.com
Contact: Katherine Huang +886-2-2627-5175 ext 19926 Katherine.Huang@meridigen.com

Locations
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Taiwan
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
New Taipei City, Taiwan, 23561
Contact: Mandy Li    +886-2-2627-5175 ext 19933    Mandy.Li@meridigen.com   
Principal Investigator: Kang-Yun Lee         
Sub-Investigator: Kuan-Yuan Chen         
Sub-Investigator: Tzu-Tao Chen         
Sub-Investigator: Yen-Han Tseng         
Sub-Investigator: Chien-Hua Tseng         
Sub-Investigator: Po-Hao Feng         
Sub-Investigator: Wen-Te Liu         
Sub-Investigator: Ching-Shan Luo         
Sub-Investigator: Yun-Kai Yeh         
Sponsors and Collaborators
Meridigen Biotech Co., Ltd.
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Responsible Party: Meridigen Biotech Co., Ltd.
ClinicalTrials.gov Identifier: NCT04347967    
Other Study ID Numbers: UMC119-06-ARDS-01
First Posted: April 15, 2020    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Meridigen Biotech Co., Ltd.:
ARDS
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury