Ignite Creation Date:
2024-07-17 @ 10:51 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491043
Status:
RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-06-21
Brief Title:
Treatment of Chronic Obstructive Pulmonary Disease by Infusion of Allogenic Mesenchymal Stem Cells
Sponsor:
Meribank Biotech Co Ltd
Organization:
Meribank Biotech Co Ltd
Study Overview
Official Title:
A Phase II Multicenter Randomized Double-Blind Placebo-Controlled Study To Evaluate The Safety And Efficacy Of Umc119-06-05 Intravenous Infusion For The Treatment Of Subjects With Moderate To Severe Chronic Obstructive Pulmonary Disease
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II study is a randomized placebo-controlled double-blind study to evaluate the safety and efficacy of UMC119-06-05 compared to placebo in treating subjects with moderate to severe COPD Eligible subjects will receive a single-dose IV infusion of UMC119-06-05 or placebo
Detailed Description:
Patients with chronic obstructive pulmonary disease 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 and corticosteroids 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 meaning it gradually gets worse over time 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 are proposed as a novel therapy with potential in treatment of COPD This clinical trial is a phase II study It is a randomized placebo-controlled double-blind study Eligible subjects will be randomized to one of the three groups placebo control low-dose UMC119-06-05 treatment or high-dose UMC119-06-05 treatment Subjects will receive a single-dose IV infusion to evaluate the efficacy and long-term safety of UMC119-06-05 with moderate to severe COPD
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None