NCT06501066

Mesenchymal Stem Cells for Frailty Syndrome

A Two-part, Phase I/II, 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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Meribank Biotech Co., Ltd. · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

This Phase I/II 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 i.e., allogenic umbilical cord mesenchymal stem cell therapy may represent a novel therapy for aging frailty. This clinical trial is a phase I/II 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.

Conditions

• Pathologic Processes

Interventions

Type	Name	Description
BIOLOGICAL	umbilical cord mesenchymal stem cells	Patients assigned to UC-MSC administration groups will receive one administrations

Timeline

• Start date: 2024-06-03
• Primary completion: 2026-12-01
• Completion: 2027-12-01
• First posted: 2024-07-15
• Last updated: 2024-07-15

Locations

2 sites across 1 country: Taiwan