Frailty Clinical Trial
— MESCAFYOfficial title:
A Pilot Study of Mesenchymal Stem Cells as Novel Therapy for Age-Related Frailty in Veterans
Verified date | February 2023 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 65 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Baylor College of Medicine, Michael E. DeBakey VA Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 4-minute walk gait speed | Time needed to walk 4 meters at the usual pace will be measured | Change from baseline to 6 months | |
Other | Activities of daily living (ADL) and instrumental ADL | Assessed using the physical function subscale of the Functional Status Questionnaire | Change from baseline to 6 months | |
Other | High-Sensitivity C-reactive protein | Marker of chronic inflammation - measured by immunoturbidimetric assay | Change from baseline to 6 months | |
Other | Knee extensor strength | as evaluated using a Biodex System 3 dynamometer | Change from baseline to 6 months | |
Other | Soluble tumor necrosis factor receptor 1 (sTNF) | Measured in serum using enzyme-linked immunoabsorbent assay | Change from baseline to 6 months | |
Other | Interleukin-6 | Measured in serum using enzyme-linked immunoabsorbent assay | Change from baseline to 6 months | |
Other | Bone mineral density of the lumbar spine and hip | Measured using dual-energy x-ray absorptiometry | Change from baseline to 6 months | |
Other | Lean body mass | Measured by dual-energy x-ray absorptiometry | Change from baseline to 6 months | |
Other | Visceral fat mass | Measured by dual-energy x-ray absorptiometry (DXA) | Change from baseline to 6 months | |
Other | Bone microarchitecture | Measured by High-resolution peripheral computed tomography (HR-pQCT) at wrist and distal radius | Change from baseline to 6 months | |
Other | Bone strength | Measured using micro-finite element analyses of HR-pQCT | Change from baseline to 6 months | |
Other | Trabecular bone score | A textual parameter that provides an index of trabecular microarchitecture | Change from baseline to 6 months | |
Other | Cognition | Using the Composite Age-Adjusted Scale Score from the National Institute of Health Toolbox Cognition Battery. | Change from baseline to 6 months | |
Other | Quality of Life | Using the Physical a nd Mental component subscale of the Medical Outcomes Study SF-36 | Change from baseline to 6 months | |
Other | Body fat | Measured using dual-energy x-ray absorptiometry | Change from baseline to 6 months | |
Other | Grip strength | Evaluated with a Jamar Handheld dynamometer | Change from baseline to 6 months | |
Other | Adverse Events | Number of non-serious and serious adverse events | Through study completion at 6 months | |
Other | Short Physical Performance Battery | Objective assessment tool for evaluating lower extremity function | Change from baseline to 6 months | |
Other | Lipoprotein levels | Measured using automated enzymatic/colorimetric assays | Change from baseline to 6 months | |
Primary | Adherence | Percent of study visits attended | Through study completion at 6 months | |
Secondary | Recruitment | Number of participants recruited | Through study completion at 6 months | |
Secondary | Modified Physical Performance Test | Includes seven standardized tests (walking 15.2 m, putting and removing a coat, picking up a penny, standing up from a chair, lifting a book, climbing one flight of stairs, and progressive romberg test) plus two additional tasks (going up and down four flights of stairs and making a 360-degree turn). Perfect score is 36 | Change from baseline to 6 months | |
Secondary | 6-Minute Walk Test | A performance based measure of functional exercise capacity. | Change from baseline to 6 months |
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