A Phase I, Open Label, Dose Escalation Study to Evaluate the Safety and Tolerability After Intravenous Infusion of UMC119-06-05 in Elderly Subjects With Mild to Moderate Frailty Syndrome.

UMC119-06-05-FS-01

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.

2021-09-01

2024-12-01

2025-07-01

Recruiting

Early phase I

6

Inclusion Criteria: * Subjects of age between ≥ 60 through ≤ 85 years. * Subjects show signs of frailty condition as assessed by the Investigator with a Clinical Frailty scale between 4 to 6. * Subjects with body weight between 40 to 90 kg. * Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided. Exclusion Criteria: * 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 or dementia. * Subjects have a score on the Mini-Mental State Examination (MMSE) of 24 or below, or have been unstable on neurological examination within the past 6 months. * Subjects who have a significant comorbid medical condition(s) including, but not limited to: 1. Severe kidney disease requiring hemodialysis or peritoneal dialysis; 2. Advanced liver disease such as hepatitis or liver cirrhosis; 3. Severe congestive heart failure (NYHA class 3 and 4); 4. Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease stage III or IV (Gold classification) 5. Hypothyroidism (TSH \> 10 mU/L) or hyperthyroidism (TSH \< 0.1 mU/L) * Subjects on chronic immunosuppressive transplant therapy. * Subjects who have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma or in situ carcinomas. * Subjects using chronic immunosuppressant therapy (including prednisone or equivalent for more than 2 consecutive weeks within the past 3 months) or TNF-alpha antagonists. * Subjects who are known to be infected with HIV. * Subjects with known allergy or hypersensitivity to any component of the formulation, including normal saline, human serum albumin, dimethyl sulfoxide (DMSO) and cellular therapies. * Subjects who have participated in another clinical study of new investigational therapies within 6 months before the study drug administration. * Subjects have a history of drug or alcohol abuse within the past 3 years. * Subjects currently in hospital stay. * Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. * Subjects with uncorrected hematology test including, but not limited to: 1. Hemoglobin \< 8 g/dl 2. White blood cell count \< 3,000/mm3 3. International normalized ratio (INR) of Coagulopathy \>1.5 4. Platelet count \< 80,000/mm3 * Subjects who have the following conditions in laboratory tests: 1. \>2 × upper limit of normal for alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 2. Total bilirubin \> 1.5 mg/dl * Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to: 1. Psychiatric illness 2. Uncontrolled hypertension or hypotension (specify numeric cutoffs) 3. Unstable cardiac arrhythmia 4. Severe osteoarthritis or degenerative joint disease 5. Hepatitis B, Hepatitis C infections 6. History of COVID-19 in the past 4 weeks or with significant COVID-19 conditions judged by PI, or ongoing COVID-19 * Have any condition that in the opinion of the Principal Investigator limits lifespan to \< 1 year.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Cohort 1: Low dose of UMC119-06-05 Cohort 1: High dose of UMC119-06-05', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 6, 'type': 'ESTIMATED'}}

2023-12-04