Mesenchymal Stem Cells for The Treatment of Frailty Syndrome

Launched by MERIDIGEN BIOTECH CO., LTD. · May 31, 2021

Keywords

ClinConnect Summary

This clinical trial, called UMC119-06-05, is looking at the safety of a new treatment using mesenchymal stem cells derived from umbilical cord tissue for older adults with frailty syndrome. Frailty syndrome is a condition often seen in older adults that makes them weaker and more vulnerable to health problems. The trial is open to people aged 60 to 85 who show signs of frailty, as determined by a specific scale. Participants must be between 40 and 90 kg and willing to provide consent to take part in the study.

If you join this trial, you will receive the stem cell treatment in a single center, and your safety will be monitored closely. This is the first phase of the trial, meaning researchers are primarily checking if the treatment is safe for participants. It’s important to note that certain health conditions, like severe heart or lung disease, or recent serious illnesses, may prevent you from participating. If you meet the eligibility criteria, you may have the opportunity to contribute to important research that could improve treatment options for frailty syndrome in the future.

Gender

ALL

Eligibility criteria

• 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.