CLINICAL PIPELINE
Longeveron is focused on developing cellular therapy primarily for chronic aging-related diseases, and other life-threatening conditions, for which there is a clear unmet medical need.
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.
*Hover over each trial to learn more
Hypoplastic Left Heart Syndrome (HLHS)
Phase 1
Phase 2
Phase 3
Funding/Partner
Phase 1 Complete. Phase 2 Ongoing.
Alzheimer's
Disease
Phase 1
Phase 2
Phase 3
Funding/Partner
Alzheimer's Disease
Phase 1 single infusion safety study complete. Phase 2 multi-dose study to initiate in 2021.
Aging Frailty
Phase 1
Phase 2
Phase 3
Funding/Partner
Aging Frailty Phase 2b
Enrollment complete. Subject follow up ongoing.
Aging Frailty (Japanese Phase 2 Study)
Initiate Phase 2 trial in 2021.
Acute Respiratory Distress Syndrome (ARDS)
Phase 1
Phase 2
Phase 3
Funding/Partner
Trial enrolling.
Bahamas Treatment Registry Trial
Bahamas Treatment Registry Trial
We sponsor a Treatment Registry Trial in The Bahamas under the approval and authority of the National Stem Cell Ethics Committee (NSCEC). Eligible participants for the Registry may receive Lomecel-B at their own expense at one of two private partner clinics in Nassau for NSCEC-approved indications: Frailty, mild cognitive impairment, Alzheimer’s Disease and related dementias, and osteoarthritis. Lomecel-B is not an approved product in The Bahamas or the United States, and is considered an investigational therapeutic. For more information about this program please contact us.
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 our own MSCs; a decrease in immune system function, known as immunosenescence; diminished blood vessel functioning; chronic inflammation, known as “inflammaging”; and other aging-related declines. Our clinical data suggest that Lomecel-B addresses these problems through multiple mechanisms of action, or MOAs, that simultaneously target key aging-related processes.
Improving healthspan is an imperative for governmental health agencies, and the NIA, an institute of the NIH, has promoted the concept of geroscience – the idea that aging itself is the biggest risk factor for aging-related human diseases. The geroscience hypothesis provides a strong rationale for the approach of treating underlying biological processes contributing to aging as a way to reduce disease burden and advance global human health. Our investments into developing and testing product candidates are aimed at reducing aging-related disease burden and improving healthspan.