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;
Sequential
HeXell-2020
DrugCohort 1: 5 × 10⁷ cells per dose, administered via IV infusion every 2 weeks for a total of 3 doses Cohort 2 : 5 × 10⁷ cells per dose, administered via IV infusion every 2 weeks for a total of 6 doses
Maximum Feasible Dose (MFD) determination
MFD is determined on the occurrence of Dose Limiting Toxicities (DLTs) after IV administration in elderly subjects with mild to moderate FS. DLT is defined as any clinically significant adverse event (AE)/serious adverse event (SAE) or clinically significant laboratory abnormality which is classified as ≥ Grade 3 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0), where applicable, is assessed as unrelated to disease progression, concurrent illness, or concomitant medications and occurring within 14 days after completion of the last study treatment .
Incidence of Treatment-Emergent Adverse Events (TEAEs).
TEAE are defined as adverse events with onset date on or after the first treatment. TEAEs will be summarized by treatment group, System Organ Class, and preferred term. The following TEAE summaries will be provided: 1. Overall (i.e., regardless of severity or relationship to treatment) 2. Adverse events by severity 3. Related adverse events by severity 4. Adverse events leading to treatment discontinuation by severity 5. Adverse events leading to death by severity
Incidence of withdrawals due to AEs
An adverse event (AE) is will be classified by system organ class (SOC) and preferred term (PT) according to the most recent version of MedDAR dictionary.
Mean change from baseline in exercise performance as measured by change in the six-minute walk test (6MWT) total distance.
The six-minute walk test (6MWT) measures the total distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway.
Mean change from baseline in hand grip strength as measured by change in maximum force using hand dynamometer.
Hand grip strength is a measure of the maximum static force that a hand can squeeze using a Baseline Hydraulic Hand Dynamometer.
Mean change from baseline in physical activity as measured by change in the Short Physical Performance Battery (SPPB) assessment total score.
The Short Physical Performance Battery (SPPB) Total Score is a measure of physical function. It is calculated by summing three measures of lower-extremity function: standing balance (side-by-side, semi-tandem, and tandem stance), 4-meter walking speed, and ability to rise from a chair. Each task is rated on a 0-4 scale, with increasing scores indicating better physical performance. The SPPB Total scores range from 0-12.
Mean change from baseline in Clinical Frailty Scale (CFS) score.
The Clinical Frailty Scale (CFS) is a common way to summarize the overall level of fitness or frailty of an elderly after they had been evaluated by an experienced clinician. CFS evaluates specific domains, including comorbidity, function, and cognition, to generate a frailty score ranging from 1 (very fit) to 9 (terminally ill). A higher score indicates a higher illness.
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