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 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT06070532
Eligibility Criteria:
Inclusion Criteria:
* Willing and able to provide written informed consent and comply with all procedures required by the protocol
* Aged \> 60 and \< 85 years at the time of signing the informed consent form
* Have a Canadian Study on Health and Aging (CSHA) Clinical Frailty Scale score of 5 "mildly frail" or 6 "moderately frail"
* Have a 6-minute walk distance of \> 200m and \< 400 m
* Have a serum TNF-alpha level \>2.5 pg/m
Exclusion Criteria:
1. Unwilling or unable to perform any of the assessments required by the protocol
2. Have a diagnosis of any disabling neurologic disorder, including, but not limited to, Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (e.g., muscle weakness or gait disorder), or diagnosis of dementia
3. Have a score of 24 or lower on the Mini Mental State Examination (MMSE)
4. Have poorly controlled blood glucose levels (HbA1c \>8.0%).
5. Have a clinical history of malignancy within 2.5 years (i.e., patients with prior malignancy must be cancer free for 2.5 years) except curatively treated basal cell carcinoma, melanoma in situ, or cervical carcinoma.
6. Have any condition that limits lifespan to \< 1 year according to the Principal Investigator's discretion
7. Have autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus).
8. Undergoes chronic immunosuppressant therapy such as high-dose corticosteroids or TNF-alpha antagonists (prednisone use at doses of \< 5 mg daily is allowed)
9. Hepatitis B virus positive
10. Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive
11. Have a resting blood oxygen saturation of \<93% (measured by pulse oximetry).
12. Known or suspected alcohol or drug abuse within three years preceding Screening
13. Have a known hypersensitivity to dimethyl sulfoxide (DMSO).
14. An organ transplant recipient (other than transplantation for corneal).
15. Actively listed (or expected future listing) for transplant of any organ (other than corneal transplant).
16. Have any clinically important abnormal screening laboratory values, including, but not limited to: i. Haemoglobin \<10.0 g/dL, ii. White blood cell \<2,500/ul, or platelet count \<100,000/ul iii. Liver dysfunction evidenced by enzymes (AST and ALT) \> 3 times the upper limit of normal (ULN)
17. Coagulopathy with an international normalized ratio (INR) \>1.3 is not due to a reversible cause (e.g., warfarin and/or Factor Xa inhibitors).
18. Uncontrolled hypertension (resting systolic blood pressure \>180 mm Hg or diastolic blood pressure of \> 110 mm Hg at screening)
19. Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within the previous 3 months.
20. Have congestive heart failure defined by New York Heart Association (NYHA) Class III or IV, or an ejection fraction of \<25%.
21. Have a coronary artery bypass surgery, angioplasty, peripheral vascular disease revascularization, or a myocardial infarction within the previous 3 months
22. Have severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung disease stage III or IV (Gold classification), and/or PaO2 levels \<60 mmHg.
23. Have a partial ileal gastric bypass or other significant intestinal malabsorption.
24. Have advanced liver or renal disease
25. Have cognitive or language barriers that prohibit obtaining informed consent or any study elements.
26. Currently hospitalized or living in an assisted living facility or a long-term care facility.
27. Currently participating (or participated within the previous 30 days of consent) in an investigational therapeutic or device trial.
28. Have a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT06070532
Study Brief:
Protocol Section:
NCT06070532