Phase 1/2Active, not recruiting
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
- Sponsor
- Meribank Biotech Co., Ltd. (Industry)
- Enrolment
- 66 enrolled
- Conditions
- Pathologic Processes
- Interventions
- umbilical cord mesenchymal stem cells
- Ages
- older adults
- Registry
- NCT06501066
From the registry
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.
Primary outcomes
- Incidence of Treatment-Emergent Adverse Events (TEAEs)/ Serious Adverse Events (SAEs).
- Incidence of withdrawals due to adverse events
- vital signs
- physical examination