Open Clinical Trials

  • CLINICAL TRIAL ID# NCT03169231 LEARN MORE

    A Phase 2b, Randomized, Blinded and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Longeveron Allogenic Human Mesenchymal Stem Cell Infusion in Patients With Aging Frailty

    Frailty is a common aging-related medical syndrome with multiple causes and contributors, characterized by diminished strength, endurance, and reduced physiologic function.  Frail individuals have an increased risk of poor clinical outcomes such as hospitalization, dependency, disability and/or death.  Signs and symptoms of frailty include reduced activity, slowness, involuntary weight loss, weakness, and fatigue.  Additionally, there is a connection between frailty and chronic inflammation in the body.  Frail elderly patients place significant demand for healthcare services and there are no approved therapeutics for the syndrome.  It is widely believed that frailty can be reversed, and in this regard there is a major need for a safe and effective treatment.

    An individual’s endogenous stem cell production decreases with age; this decrease likely contributes to the reduced ability to regenerate and repair organs and tissues. It is predicted that regenerative treatment could ameliorate symptoms of frailty, and potentially extend the health and ability of a patient to regenerate functionality. Human Mesenchymal Stem Cells are known to home to sites of injury, reduce inflammation, and assist in cellular repair, thus could be an ideal candidate for frailty. The purpose of this study is to measure the safety and efficacy of Longeveron Allogeneic Mesenchymal Stem Cells in patients with aging frailty.

    Primary Outcome Measures:

    1. Change in 6 Minute Walk Test (6MWT) distance compared to placebo at 180 days post-infusion 
    2. Change in TNF-a compared to placebo at 180 days post-infusion

     

    Secondary Outcome Measures:

    1. Change in patient reported outcome of overall physical function capacity using the PROMIS-Physical Function-Short Form 20a compared to placebo at 180 days post-infusion
    2. Change from baseline in physical function will be measured to assess Patient-Reported Outcome Measurement compared to placebo at 180 days post infusion
    3. Change in TNF-alpha compared to placebo at 180 days post-infusion
    4. Change in serum TNF-alpha compared to placebo

     

    Criteria to participate include the following factors:

    • Subjects must be between 70 and 85 years of age at time of signing the informed consent form
    • Subjects must be diagnosed as mildly to moderately frail per the CSHA Clinical Frailty Scale
    • Subjects must have a serum TNF-alpha level greater than or equal to 2.5 pg/mL
    • Subjects must not have a diagnosis of a disabling neurologic disorder such as Parkinson’s disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, cerebrovascular accident with residual deficits (e.g., muscle weakness or gait disorder), or diagnosis of dementia

     

    For a complete list of inclusion and exclusion criteria or to Learn More 

  • CLINICAL TRIAL ID# NCT02600130 LEARN MORE

    Allogeneic Human Mesenchymal Stem Cell Infusion Versus Placebo in Patients With Alzheimer’s Disease

    Alzheimer’s disease is a neurodegenerative disorder that leads to progressive memory loss and death. This is a Phase I, prospective, randomized, placebo-controlled, double-blinded study designed to test the safety and efficacy of LMSCs (Longeveron Mesenchymal Stem Cells) for the treatment of subjects with clinically diagnosed Alzheimer’s disease.

    Primary Outcome Measure:

    1. To demonstrate the safety of LMSCs administered to subjects with Alzheimer’s disease.

    Secondary Outcome Measure:

    1. Preliminary efficacy will be determined by examining for changes in Alzheimer’s disease status and rate of decline as assessed by factors outlined in the complete study description.

    Criteria to participate include the following factors:

    • Subjects must be between 50 and 80 years of age at time of signing informed consent form
    • Subjects must be diagnosed with mild Alzheimer’s disease in accordance with the NINCDS-AA criteria.
    • Subjects must have a body weight of 45 – 150 kg
    • Subjects must be using an acetylcholinesterase inhibitor and/or Memantine treatment on a stable dosage for at least four months prior to screening
    • Subjects must be negative for hepatitis B HsAg, viremic hepatitis C and HIV

     

    For a complete list of inclusion and exclusion criteria or to Learn More

  • CLINICAL TRIAL ID# NCT02982915 LEARN MORE

    Human Mesenchymal Stem Cells (LMSCs) on Vaccine-Specific Antibody- Response in Subjects With Aging Frailty (HERA)

    Frailty in an aging population is defined as a medical syndrome with multiple causes and contributors that is characterized by diminished strength, endurance, and reduced physiologic function that increases an individual’s vulnerability for developing increased dependency and/or death. Frailty is associated with a decreased immune response, which means that your body’s ability to fight off infections decreases, and your body’s ability to respond positively to vaccination, such as the influenza vaccine, decreases. The purpose of this study is to measure the safety of treatment with Longeveron mesenchymal stem cells to improve vaccine response in patients with Aging Frailty.

    Primary Outcome Measures:

    1. The incidence of any treatment-emergent serious adverse event (TE-SAE), within 30 days after infusion as listed in the trial description
    2. Changes from baseline through month 12 in adaptive immunity and primary B cell response to the influenza vaccine in subjects with Aging Frailty

    Secondary Outcome Measures:

    1. Post-vaccination changes from baseline in the influenza specific plasmablast differential between the LMSC and Placebo Cohorts
    2. Changes from baseline between the LMSC and Placebo Cohorts as assessed by biomarkers
    3. Differences in rate of decline from Aging Frailty
    4. Changes in subject quality of life
    5. Death from any cause

    Criteria to participate include the following factors:

    • Subjects must be 65 – 85 years of age at the time of signing the informed consent form
    • Subjects must have a diagnosis of frailty with a score of 4 to 7 using the Canadian Frailty Scale
    • Subjects must have a serum TNF-alpha level greater than or equal to 2.5 pg/mL
    • Subjects must have 6MWT distance between 200 – 400 m
    • Subjects cannot have received the current year’s influenza vaccine

     

    For a complete list of inclusion or exclusion criteria or to Learn More

  • CLINICAL TRIAL ID# NCT02587572 LEARN MORE

    Safety and Efficacy Trial Using Allogeneic Human Mesenchymal Stem Cells: The SIRONA Trial (SIRONA)

    The Metabolic Syndrome is defined as a cluster of conditions that include high blood pressure, high blood sugar, excess body fat and abnormal cholesterol or triglyceride levels. The purpose of this study is to measure the safety of treatment with Longeveron mesenchymal stem cells in patients with the Metabolic Syndrome.

    Primary Outcome Measures:

    1. Endothelial function: Changes in endothelial function as assessed by defined criteria at 1 month post infusion
    2. Flow-mediated vasodilation (FMD). Endothelial progenitor cell (EPC) function

    Secondary Outcome Measures:

    1. Difference in rate of change in the metabolic syndrome as defined by the trial criteria including Endothelial function (FMD, EPC function), Inflammatory markers, Heart function and structure, Blood pressure, Lipid profile, Physical activity (6 minute walk test), Lung function (spirometry), Glycemia, Weight, Subject quality of life assessments

    Criteria to participate include the following factors:

    • Subjects must be 45 to 85 years of age at time of signing informed consent form
    • Subjects must have endothelial dysfunction
    • At time of enrollment, each subject must meet at least three out of five criteria under the harmonized definition of the metabolic syndrome, consisting of Hypertension, elevated triglycerides, reduced high-density lipoprotein levels (HDL), elevated fasting glucose, central obesity

     

    For a complete and detailed list of inclusion and exclusion criteria or to Learn More