| Eligibility |
Inclusion Criteria:
1. Be willing and able to provide written informed consent and comply with all procedures
required by the Protocol.
2. Be >70 and < 85 years of age at the time of signing the Informed Consent Form.
3. Have a Canadian Study on Health and Aging (CSHA) Clinical Frailty Scale score of 5
"mildly frail" or 6 "moderately frail".
4. Have a 6 minute walk distance of > 200m and < 400 m. Distances of two 6MWTs are to be
within 15% of each other.
5. Have a serum TNF-alpha level > 2.5 pg/mL
Exclusion Criteria:
1. Be 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., subjects 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 in the opinion of the Principal Investigator limits lifespan
to < 1 year.
7. Have autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus).
8. Be using chronic immunosuppressant therapy such as high-dose corticosteroids or
TNF-alpha antagonists (prednisone use at doses of < 5 mg daily is allowed).
9. Test positive for hepatitis B virus
a. 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.
10. Test positive for verimic Hepatitis C virus, HIV1/2, or syphilis
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. Be an organ transplant recipient (other than transplantation for corneal, bone, skin,
ligament, or tendon).
15. Be 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:
1. Hemoglobin <10.0 g/dL,
2. White blood cell <2,500/ul, or platelet count <100,000/ul
3. Liver dysfunction evidenced by enzymes (AST and ALT) > 3 times the upper limit of
normal (ULN)
4. Coagulopathy (INR>1.3) not due to a reversible cause (e.g. warfarin and/or Factor
Xa inhibitors).
17. Uncontrolled hypertension (resting systolic blood pressure >180 mm Hg or diastolic
blood pressure of > 110 mm Hg at Screening)
18. Have unstable angina pectoris, uncontrolled or severe peripheral artery disease within
the previous 3 months.
19. Have congestive heart failure defined by NYHS (New York Heart Association) Class III
or IV, or an ejection fraction of <25%.
20. Have a coronary artery bypass surgery, angioplasty, or peripheral vascular disease
revasculation or a myocardial infarction within previous 3 months.
21. Have severe pulmonary dysfunction: acute exacerbation of chronic obstructive lung
disease stage III or IV (Gold classification), and/or PaO2 levels <60 mmHg.
22. Have a partial ileal gastric bypass, or other significant intestinal malabsorption.
23. Have advanced liver or renal disease
24. Have cognitive or language barriers that prohibit obtaining informed consent or any
study elements.
25. Be currently hospitalized, or living in an assisted living facility or a long-term
care facility.
26. Be currently participating (or participated within the previous 30 days of consent) in
an investigational therapeutic or device trial.
27. 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.
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