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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
Patients assigned to UC-MSC administration groups will receive one administrations
National Taiwan University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Incidence of Treatment-Emergent Adverse Events (TEAEs)/ Serious Adverse Events (SAEs).
Phase I : Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Time frame: Up to 12 months through study
Incidence of withdrawals due to adverse events
Phase I: Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Time frame: Up to 12 months through study
vital signs
Phase I: change in vital signs
Time frame: Up to 12 months through study
physical examination
Phase I: change in physical examination
Time frame: Up to 12 months through study
clinical laboratory test results
Phase I: change in clinical laboratory test results
Time frame: Up to 12 months through study
electrocardiogram
Phase I: change in electrocardiogram
Time frame: Up to 12 months through study
Mean change from baseline in frailty status (Cardiovascular Health Study [CHS] frailty score
CHS scale consists of five components-unintentional weight loss, exhaustion, low activity, weakness, and slowness
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Time frame: change from baseline to Day 91, Day 181, and Day 361
Mean change from baseline in grip strength
Hand grip strength as assessed by a dynamometer. Grip strength is recorded (in mmHg) three times for each hand.
Time frame: change from baseline to Day 91, Day 181, and Day 361
Mean change from baseline in chair-stand test
a subject is able to transfer from a seated to a standing position and back to sitting five times
Time frame: change from baseline to Day 91, Day 181, and Day 361
Mean change from baseline in muscle mass and bone density
muscle mass and bone density will be measured using DXA
Time frame: change from baseline to Day 91, Day 181, and Day 361
Mean change from baseline in quality of life measured by change in SF-12
a quality of life measure
Time frame: change from baseline to Day 91, Day 181, and Day 361