Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:13 PM
Ignite Modification Date:
2025-12-24 @ 4:13 PM
NCT ID:
NCT06501066
Eligibility Criteria:
Inclusion Criteria:
Subjects will be eligible for enrollment in the study only if they meet ALL of the following criteria:
1. Subjects of age ≥ 65 years old at screening.
2. Subjects show signs of frailty as assessed by CHS frailty Scores ≥ 1 at screening.
3. Subjects with body weight between 40 kg to 90 kg.
4. Subjects have received standard of care treatment (including exercise and nutritional supplementation) for FS for at least 30 days prior to the study.
5. 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 will be eligible for enrollment in the study only if they meet NONE of the following criteria:
1. Subjects unwilling or unable to perform any of the assessments required by endpoint analysis.
2. Subjects who have a significant comorbid medical condition(s), as judged by the investigator, including, but not limited to:
1. Confirmed diagnosis of disabling neurologic disorder, including but not limited to Parkinson's disease, Amyotrophic lateral sclerosis, Stroke, or dementia, that significantly impact the assessments for endpoint analysis;
2. Severe kidney disease requiring hemodialysis or peritoneal dialysis;
3. Advanced liver disease such as hepatitis or liver cirrhosis;
4. Severe congestive heart failure (New York Heart Association \[NYHA\] class 3 and 4);
5. Autoimmune disease (rheumatoid arthritis, psoriasis/psoriatic arthritis, multiple sclerosis, systemic lupus erythematosus, etc.);
6. Hearing or visual impairment that significantly impact the assessments for endpoint analysis;
7. Pulmonary dysfunction requiring steroid therapy or O2 supplementation
8. Uncontrolled metabolic diseases including type II diabetes mellitus (hemoglobin A1c \[HbA1c\] \> 8.5%)
3. Subjects carry history of malignancy of any organ system (other than curatively treated localized basal or squamous cell carcinoma of the skin, cervical carcinoma in situ) within 5 years prior to the screening visit.
4. Subjects using chronic high dose of steroid (\> 5 mg prednisolone or equivalent), immunosuppressant therapy, or TNF-α antagonists.
5. Subjects with human immunodeficiency virus (HIV), active hepatitis B virus (HBV) or hepatitis C virus (HCV) infections.
6. Subjects with known allergy or hypersensitivity to any component of the formulation (normal saline, human serum albumin, or dimethyl sulfoxide).
7. Subjects who have participated in another clinical study of new investigational therapies within 3 months before the study drug administration.
8. Subjects who have received any other stem cell therapy within 12 months before the study drug administration.
9. Subjects have a history of moderate to severe substance use disorder (including alcohol, cannabis, hallucinogens, inhalants, opioids, sedatives/hypnotics/anxiolytics, and stimulants \[e.g., amphetamine-type substance, cocaine\]) based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5) within the past 3 years.
10. Subjects who have any hospitalization record within one month before the study drug administration (except for the scheduled admission in this study, if required).
11. Subjects who have dramatic change in their standard of care treatment (including exercise and nutritional supplements) for improvement of frailty within one month prior to study treatment, as judged by the investigator.
12. 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT06501066
Study Brief:
Protocol Section:
NCT06501066