A Pilot Study of Mesenchymal Stem Cells as Novel Therapy for Age-Related Frailty in Veterans

E4096-P

Frailty is a health state related to the aging process in which multiple body systems gradually lose their built-in reserves. It is a medical condition of reduced function in older adults which is associated with increased risks of adverse outcomes such as falls, disability, admission to hospital, or need for long-term care. Currently, there is no specific medical treatment of frailty. Mesenchymal stem cells (MSCs) are undifferentiated cells that self-replicated, and some may change into a particular cell type. These cells go to areas of injury due to signals released by injured cells. Upon reaching, the target tissue, MSCs repair injury by releasing growth factors and immune modulators to assist in the body's repair process. This initial study will assess the practicability of using MSCs for age-related frailty and provide information for planning a future full study of MSCs for maximizing Veteran's functional independence.

2023-01-31

2023-01-31

2023-01-31

Withdrawn

Early phase I

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

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2023-02-06