A Study to Evaluate Allogenic Bone-Marrow Mesenchymal Stromal Cell Product StromaForte in Aging Frailty Patients

Inclusion Criteria:

• Willing and able to provide written informed consent and comply with all proceduresrequired 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/ml

Exclusion Criteria:

• Unwilling or unable to perform any of the assessments required by the protocol
• 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 gaitdisorder), or diagnosis of dementia
• Have a score of 24 or lower on the Mini Mental State Examination (MMSE)
• Have poorly controlled blood glucose levels (HbA1c >8.0%)
• Have a clinical history of malignancy within 2.5 years (i.e., patients with priormalignancy must be cancer free for 2.5 years) except curatively treated basal cellcarcinoma, melanoma in situ or cervical carcinoma
• Have any condition that limits lifespan to < 1 year according to the PrincipalInvestigator discretion
• Have autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus)
• Undergoes chronic immunosuppressant therapy such as high-dose corticosteroids or TNF-αantagonists (prednisone use at doses of < 5 mg daily is allowed)
• Hepatitis B virus positive
• Viraemic Hepatitis C virus, HIV-1/2 or syphilis positive
• Have a resting blood oxygen saturation of <93% (measured by pulse oximetry)
• Known or suspected alcohol or drug abuse within three years preceding Screening
• Have a known hypersensitivity to dimethyl sulfoxide (DMSO)
• An organ transplant recipient (other than transplantation for corneal)
• Actively listed (or expected future listing) for transplant of any organ (other thancorneal transplant)
• Have any clinically important abnormal screening laboratory values, including, but notlimited to: i. Haemoglobin <10.0 g/dL, ii. White blood cell <2,500/ul, or plateletcount <100,000/ul iii. Liver dysfunction evidenced by enzymes (AST and ALT) > 3 timesthe upper limit of normal (ULN)
• Coagulopathy with international normalized ratio (INR) >1.3 not due to a reversiblecause (e.g., warfarin and/or Factor Xa inhibitors)
• Uncontrolled hypertension (resting systolic blood pressure >180 mm Hg or diastolicblood pressure of > 110 mm Hg at Screening)
• Have unstable angina pectoris, uncontrolled or severe peripheral artery disease withinthe previous 3 months
• Have congestive heart failure defined by New York Heart Association (NYHA) Class IIIor IV, or an ejection fraction of <25
• Have a coronary artery bypass surgery, angioplasty, or peripheral vascular diseaserevascularization or a myocardial infarction within previous 3 months
• Have severe pulmonary dysfunction: acute exacerbation of chronic obstructive lungdisease stage III or IV (Gold classification), and/or PaO2 levels <60 mmHg
• Have a partial ileal gastric bypass, or other significant intestinal malabsorption
• Have advanced liver or renal disease
• Have cognitive or language barriers that prohibit obtaining informed consent or anystudy elements
• (or participated within the previous 30 days of consent) in an investigationalCurrently hospitalized or living in an assisted living facility or a long-term carefacility
• Currently participating therapeutic or device trial
• 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 withthe patient's participation for the full duration of the study