Mesenchymal Stem Cells for The Treatment of Frailty Syndrome

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.