Ignite Creation Date:
2024-07-17 @ 11:02 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501066
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-06-18
Brief Title:
Mesenchymal Stem Cells for Frailty Syndrome
Sponsor:
Meribank Biotech Co Ltd
Organization:
Meribank Biotech Co Ltd
Study Overview
Official Title:
A Two-part Phase III Randomized Single-blind Study to Evaluate the Efficacy and Safety of UMC119-06-05 in Older Adults With Pre-frailty Frailty
Status:
ACTIVE_NOT_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 III study is designed to evaluate the efficacy and safety of UMC119-06-05 an allogeneic umbilical cord mesenchymal stem cells in older adults with frailty syndrome This study will also seek to determine the long-term safety and clinical outcomes of UMC119-06-05 in subjects with frailty syndrome which will provide information for subsequent clinical trials with UMC119-06-05
Detailed Description:
Frailty is a disorder of several inter-related physiological systems including genetic and environmental factors in combination with epigenetic mechanisms which regulate the differential expression of genes in cells and could be especially important in ageing Frailty syndrome characterized by a progressive decline in health and clinical symptoms of exhaustion weight loss a feeling of slowing down and a decrease in functional capacity Current interventions focus on interdisciplinary approaches which include nutritional supplementation physical exercise and cognitive intervention The lack of standardized treatment of the disease resulted in the increasing number of elders diagnosed with frailty Therefore development of new therapeutic modalities to improve the clinical outcomes and prognosis of frailty syndrome in adult patients is of urgent need Recently preclinical and clinical studies support a cell-based regenerative treatment strategy ie allogenic umbilical cord mesenchymal stem cell therapy may represent a novel therapy for aging frailty This clinical trial is a phase III study Phase I is an open-label study and all eligible subjects will receive a single-dose IV infusion of UMC119-06-05 Phase II study is a randomized placebo-controlled single-blind study and half of eligible subjects will receive a single-dose IV infusion of UMC119-06-05 the others will receive placebo
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