Status:
WITHDRAWN
Mesenchymal Stem Cells for Age-Related Frailty
Lead Sponsor:
VA Office of Research and Development
Collaborating Sponsors:
Michael E. DeBakey VA Medical Center
Baylor College of Medicine
Conditions:
Frailty
Eligibility:
All Genders
65-85 years
Phase:
PHASE1
PHASE2
Brief Summary
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 ass...
Detailed Description
Frailty is an aging-related syndrome of impaired physiologic reserve and function across multiple organs, leading to increased vulnerability for adverse health outcomes. Frailty is associated with an ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05284604
Start Date
January 31 2023
End Date
January 31 2023
Last Update
February 6 2023
Active Locations (1)
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1
Michael E. DeBakey VA Medical Center, Houston, TX
Houston, Texas, United States, 77030-4211