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

NCT04347967 | Unknown Phase 1 DMC FDA Drug

• 1 other identifier: UMC119-06-ARDS-01
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDS

Outcome Measures

Primary Outcomes (1)

• The incidence and frequency of adverse events related to administration of UMC119-06.

  Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to AEs.

  3 months from the day of administration

Secondary Outcomes (7)

• Changes in mortality status

  15 months from the day of administration.

• Ventilator Free Days (VFD)

  28 days from the day of administration

• Change in Oxygenation Index (OI)

  7 days or discharge from ICU after the day of administration

• Change in Lung Injury Score (LIS)

  7 days or discharge from ICU after the day of administration

• Change in positive end-expiratory pressure (PEEP)

  7 days or discharge from ICU after the day of administration

Study Arms (1)

UMC119-06

EXPERIMENTAL

Human Umbilical Cord Derived-Mesenchymal Stem Cells, Single treatment by intravenous infusion.

Biological: UMC119-06

Interventions

UMC119-06 BIOLOGICAL

Cohort 1: Low does of UMC119-06；Cohort 2: Medium does of UMC119- 06；Cohort 3: High does of UMC119-06

UMC119-06

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects of age ≥ 20 years and ≤ 85 years.
• Subject has a diagnosis of moderate ARDS according to the Berlin definition of ARDS:
• No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
• Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph.
• Hypoxemia: PaO2/ FiO2 \> 100 mmHg to ≤ 200 mmHg with PEEP ≥ 5 cm H2O.
• 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:
• 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;
• weeks post-surgical bilateral oophorectomy with or without hysterectomy.

You may not qualify if:

• 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:
• \>5 × upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST).
• \>3 × upper limit of normal for total bilirubin.
• \>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.

Sponsors & Collaborators

• Meridigen Biotech Co., Ltd.: lead

Study Sites (1)

Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.

New Taipei City, 23561, Taiwan

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Central Study Contacts

Claire Liao

CONTACT

+886-2-8978-7777; claire.liao@meridigen.com

Joseph Chen

CONTACT

+886-2-8978-7777; joseph.chen@meridigen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: January 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2025
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)