The clinical study with UMC119-06-05 is designed to investigate the safety in patients with frailty syndrome. This will be a dose escalation, open label, single-center study in adult with frailty syndrome. UMC119-06-05 is ex vivo cultured human umbilical cord tissue-derived mesenchymal stem cells product which is intended for treatment of frailty syndrome.
Frailty syndrome is the most problematic expression of population ageing and profound implications for the planning and delivery of health and social care when population ageing is accelerating rapidly worldwide, from 461 million people older than 65 years in 2004 to an estimated 2 billion people by 2050 . 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. Frailty is a common clinical syndrome in older adults that carries an increased risk for poor health outcomes including falls, incident disability, hospitalization, and mortality. Health study as meeting three out of five phenotypic criteria: low grip strength, self-reported exhaustion, slowed walking speed, low physical activity, and unintentional weight loss. 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. Current interventions focus on interdisciplinary approaches which include nutritional supplementation, physical exercise, and cognitive intervention. Clinical studies of these preventative approaches have shown inconsistent and modest benefits, further highlighting the unmet clinical need. Therefore, development of new therapeutic modalities to improve the clinical outcomes and prognosis of frailty syndrome in adult patients is of urgent need. A variety of pharmacologic and biologic therapies are currently being tested to treat aging. Among the more innovative, experimental therapies, Mesenchymal Stromal Cells (MSCs) are represents an attractive option that addresses the pathophysiology of the syndrome.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Cohort 1: Low does of UMC119-06-05 Cohort 2: High does of UMC119-06-05
Taipei Medical University - Shuang Ho Hospital, Ministry of Health and Welfare.
New Taipei City, Taiwan
RECRUITINGThe incidence and frequency of adverse events related to administration of UMC119-06-05.
Incidence of Treatment-Emergent Adverse Events (TEAEs). Incidence of withdrawals due to Adverse Events(AEs).
Time frame: 3 months from the day of administration
Changes in exercise performance using 6-min walk test (6MWT).
The distance (meter) and walking speed (meter per seconds) in a 6-minute walk test. Improvement in clinical function as assessed by mean change in exercise performance using 6-min walk test (6MWT).
Time frame: From baseline up to 360 days after administration.
Changes in grip strength.
Hand grip strength can be quantified by measuring the amount of static force that the hand can squeeze around a dynamometer. The force has most commonly been measured in kilograms.
Time frame: From baseline up to 360 days after administration.
Changes in quality of life measured by change in SF12 (12-Item Short Form).
The 12-Item Short Form Health Survey (SF-12) is a 12-item measure of perceived health status with good reliability, validity and correlation with other health measures. The score is computed using the scores of the twelve questions and range from 0 to 100, where a zero score indicates the lowest level of health and 100 indicates the highest level of health.
Time frame: From baseline up to 360 days after administration.
Changes in physical activity using International Physical Activity Questionnaire (IPAQ) questionnaire
The IPAQ calculates the metabolic equivalent (MET) score by asking participants the days and minutes exercised in three categories of intensity (vigorous, moderate, and walking) during the previous one week. Categorical score to three levels of physical activity are Low, or Moderate, or High.
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Time frame: From baseline up to 360 days after administration.
Changes in Forced Expiratory Volume in One Second (FEV1).
Improvement in clinical function as assessed by mean change in One Second to the Forced Vital Capacity.
Time frame: From baseline up to 360 days after administration.
Changes in Clinical Frailty Scale.
Clinical Frailty Scale evaluates specific domains, including comorbidity, function, and cognition, to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill).
Time frame: From baseline up to 360 days after administration.