This is a phase I study to investigate the safety, and Tolerability of HeXell-2020 in Elderly Subjects with Mild to Moderate Frailty Syndrome.
HeXell-2020 is an investigational drug product consisting of allogenic umbilical cord mesenchymal stem cells (UCMSCs) as the drug substance. All enrolled and eligible subjects will receive HeXell-2020 treatment.
Subjects aged ≥ 60 through ≤ 85 years old.
Subjects with clinical diagnosis of mild to moderate Frailty Syndrome as assessed by the Investigator with a Clinical Frailty Scale score between 4 to 6.
Subject will not start any new treatment for this condition during the study.
Subjects with body weight between 40 to 90 kg.
Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.
Subjects who have a diagnosis of any disabling neurologic disorder including, but not limited to: Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, stroke or dementia.
Subjects who have a score on the Mini-Mental State Examination (MMSE) of 24 or below.
Severe kidney disease requiring hemodialysis or peritoneal dialysis;