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 @ 7:56 PM
Ignite Modification Date:
2025-12-24 @ 7:56 PM
NCT ID:
NCT05284604
Eligibility Criteria:
Inclusion Criteria:
* Age 65 - 85 years and living in the community
* Modified Physical Performance Test score of 18 to 31
* Clinical Frailty Scale score of 5 or 6
* 6-minute walk distance of \>200m and \<400m
* Willing to provide informed consent
Exclusion Criteria:
* Failure to provide informed consent
* Major cardiopulmonary disease (e.g., recent MI, unstable angina, stroke) or unstable disease (e.g. NYHA Class II or IV congestive heart failure, severe pulmonary disease requiring steroid pills or the use of supplemental oxygen
* Severe neuromuscular disease (e.g., multiple sclerosis, Parkinson's disease, Amyotrophic lateral sclerosis)
* Renal impairment as defined by an estimated glomerular filtration rate (eGFR or less than 30 ml/min/1.73 m2)
* Other significant co-morbid disease (e.g., severe psychiatric disorder \[e.g. bipolar, schizophrenia\], excess alcohol use (\>14 drinks per week)
* Uncontrolled hypertension (BP\>160/90 mm Hg)
* Significant cognitive impairment, defined as a known diagnosis of dementia or positive screening test for dementia using the Mini-Mental State Exam (i.e., MMSE score \<24)
* Poorly controlled diabetes (HbA1c \>8.5%)
* History of malignancy during the past 5 years (except non-melanoma skin cancers)
* Have autoimmune disease (e.g., Rheumatoid arthritis, systemic lupus erythematosus)
* Be using chronic immunosuppressant therapy such as high-dose corticosteroids or TNF-alpha antagonists (prednisone use at doses of \< 5 mg daily is allowed)
* Test positive for hepatitis B virus - If the subject tests positive for anti-hepatitis B core antigen (HBc) or anti-HBs, they must be currently receiving treatment for Hepatitis B prior to infusion and remain on treatment throughout the study
* Test positive for Hepatitis C virus, HIV1/2, or syphilis
* Have any clinically important screening laboratory values, including hemoglobin \<10.0 g/dL, WBC \<2.500/ul or platelet count\<100,000/ul, AST or ALT \> 3 times the upper limit of normal, INR\>1.3 not due to reversible cause (e.g., warfarin)
* Treatment with another investigational drug or other intervention within three months
* A history or current evidence of any condition, laboratory abnormality, or other circumstance that might confound the interpretation of the results
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
85 Years
Study:
NCT05284604
Study Brief:
Protocol Section:
NCT05284604