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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Cohort 1: Low does of UMC119-06;Cohort 2: Medium does of UMC119- 06;Cohort 3: High does of UMC119-06
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
New Taipei City, Taiwan
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.
Time frame: 3 months from the day of administration
Changes in mortality status
Improvement in mortality status.
Time frame: 15 months from the day of administration.
Ventilator Free Days (VFD)
Improvement in clinical function as assessed by Ventilator Free Days (VFD).
Time frame: 28 days from the day of administration
Change in Oxygenation Index (OI)
Improvement in clinical function as assessed by change in Oxygenation Index (OI).
Time frame: 7 days or discharge from ICU after the day of administration
Change in Lung Injury Score (LIS)
Improvement in clinical function as assessed by change in Lung Injury Score (LIS), 0-16 points, severity increasing with higher points.
Time frame: 7 days or discharge from ICU after the day of administration
Change in positive end-expiratory pressure (PEEP)
Improvement in clinical function as assessed by change in positive end-expiratory pressure (PEEP).
Time frame: 7 days or discharge from ICU after the day of administration
Change in Lung Static Compliance
Improvement in clinical function as assessed by change in Lung Static Compliance
Time frame: 7 days or discharge from ICU after the day of administration
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Change in acute physiology and chronic health evaluation score (APACHE II)
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.
Time frame: 7 days from the day of administration