Cellular Therapy to Repair, Regenerate, and Restore
Developing therapeutics derived from cells within our own body whose function is to repair and regenerate tissue at the site of damage, inflammation and disease.
We are a clinical-stage biotechnology company developing cellular therapies for aging-related and life-threatening conditions. Our lead investigational product is Lomecel-B™, which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young healthy adult donors. We believe that by using the same cells that promote tissue repair, organ maintenance, and immune system function, we can develop safe and effective therapies for some of the most difficult diseases and conditions associated with aging.
We are currently conducting Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS), which is the current exception to our focus on aging. Our mission is to advance
Lomecel-B™ and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization and broad use by the healthcare community.
Our philosophy is that healthy aging can be improved through regenerative medicine approaches. Life expectancy has substantially increased over the past century as a result of medical and public health advancements. However, this increase in longevity has not been paralleled by the number of years a person is expected to live in relatively good health, free of chronic disease and disabilities of aging – a period known as healthspan. As we age, we experience a profound decline, in both number and function, in our own MSCs, a decrease in immune system function, decline in blood vessel functioning, chronic inflammation and other issues. Our clinical data suggest that Lomecel-B™ addresses these conditions through multiple mechanisms of action, or MOAs, that simultaneously target key aging-related processes.
Research Areas of Focus
Why do some age well while others become frail? As a society, we are living longer than we did 100 years ago, but longevity comes with longer period of living with disability. Can we extend the period of time that we live in relatively good health, free of chronic disease, dependence and disability, a period known as “healthspan”? Individuals with Aging Frailty are at higher risk for adverse health outcomes such as falls, fractures, loss of independence, susceptibility to infection, institutionalization, hospitalization and death.
At Longeveron, we are leading the efforts to develop a regenerative medicine approach for intervention and treatment of Aging Frailty.
Alzheimer’s disease, which affects over 5 million Americans, is a neurodegenerative disorder that leads to progressive memory loss and death. There are few drugs available for treating Alzheimer’s disease, and none that affect the long-term progression of the disease. Longeveron has partnered with the Alzheimer’s Association to advance clinical research using a cell therapy approach to treating this devastating disease.
The Metabolic Syndrome is a multifactorial condition characterized by cluster of conditions that increases the risk heart disease, stroke and diabetes. These conditions include obesity around the central area of the body, high blood sugar, dyslipidemia (elevated cholesterol or fats in the blood) and hypertension (high blood pressure). As part of our Aging Frailty program, we are exploring the effect of cell therapy on cluster of risk factors associated with the Metabolic Syndrome.
Acute Respiratory Distress Syndrome (ARDS)
Longeveron is researching the potential for cell therapy to treat the deadly condition of Acute Respiratory Distress Syndrome, or ARDS. ARDS occurs when fluid builds up in the lungs (sometimes referred to as “wet lung”), which impairs the ability for oxygen to get into the body and blood stream. ARDS can be caused by illnesses such as influenza or COVID-19 infection. Because age is one of the primary risk factors for infection with coronavirus and influenza, and for the development of ARDS, it is imperative that safe and effective treatments are developed to address this often fatal condition. We are conducting a Phase 1 trial for ARDS associated with influenza and COVID-19 infection.
Hypoplastic Left Heart Syndrome (HLHS)
HLHS is a severe congenital birth defect in which the left ventricle of the heart is either severely underdeveloped or missing. Babies born with this condition have severely diminished systemic blood flow, leading to immediate cardiopulmonary complications that are only addressable through a staged reconstructive surgical approach. We are testing the ability for cell therapy to improve cardiac function in these children.