NCT04206007

Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease

The Safety and Feasibility of UMC119-06 Cell Therapy in Subjects With Chronic Obstructive Pulmonary Disease

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Meridigen Biotech Co., Ltd. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The clinical study with UMC119-06 is designed to investigate the safety in patients with Chronic Obstructive Pulmonary Disease. This will be a dose escalation, open label, single-center study in adult with chronic obstructive pulmonary disease. UMC119-06 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of chronic obstructive pulmonary disease.

Detailed description

Chronic Obstructive Pulmonary Disease (COPD) is a leading cause of morbidity and mortality worldwide, predicted to be the third leading cause of death in adults by 2020. Patients with COPD are characterized with airflow limitation and chronic inflammation, which is caused by cigarette smoking, noxious particles or gases. These inhaled irritants will induce inflammation, emphysema and fibrosis though chronic exposure. The current pharmacological treatment of COPD is symptomatic and is mainly based on bronchodilators, such as selective β2-adrenergic agonists (short-and long-acting), anticholinergics, theophylline, or a combination of these drugs. In patients with continuing exacerbations, inhaled corticosteroids (ICSs) may be added in the form of a triple fixed dose combination inhaler that includes ICSs, long-acting β2-agonists (LABA) and inhaled long-acting muscarinic antagonists (LAMA). Although current clinical treatment strategies can improve and stabilize COPD states and quality of life, none of them are able to modify the progressive decline in lung function which is the hallmark of this disease. Therefore, development of new therapeutic modalities to improve the clinical outcomes and prognosis of COPD in adult patients is of urgent need. Among the more innovative, experimental therapies, mesenchymal stromal cells (MSCs) are proposed as a novel therapy with potential in treatment of COPD.

Conditions

• Chronic Obstructive Pulmonary Disease Moderate

Interventions

Type	Name	Description
BIOLOGICAL	UMC119-06	Cohort 1: Low does of UMC119-06 Cohort 2: Medium does of UMC119- 06 Cohort 3: High does of UMC119-06

Timeline

• Start date: 2020-06-11
• Primary completion: 2023-12-31
• Completion: 2024-06-30
• First posted: 2019-12-20
• Last updated: 2023-12-04

Locations

1 site across 1 country: Taiwan

Regulatory

• FDA-regulated drug study