Open Clinical Trials

  • 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:
    • Subject must be between 50 and 80 years of age at time of signing consent
    • Must be diagnosed with mild Alzheimer’s disease in accordance with the NINCDS-AA criteria.
    • Subject must have a body weight of 45 – 150 kg
    • Must be using an acetylcholinesterase inhibitor and/or Memantine treatment on a stable dosage for at least four months prior to screening
    • 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
    • Cannot have received the current year’s flu 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. [ Time Frame: 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:
    2. Endothelial function (FMD, EPC function) Inflammatory markers, Heart function and structure (Dobutamine Stress Echocardiography), Blood pressure Lipid profile, Physical activity, Lung function (spirometry), Glycemia, Weight Subject quality of life

     

    Criteria to participate include the following factors:
    • Must be 45 to 85 years of age at time of signing informed consen
    • 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