Longeveron is developing Lomecel-B, an allogeneic human mesenchymal stem cell (MSC) product for a variety of diseases, some of which are age-related. Currently, the company is in multiple clinical trial stages with its flagship product, including a phase 1/2 trial for vaccine immune response, a phase 2b trial for metabolic syndrome, and a phase 1/2 trial for hypoplastic left heart syndrome in infants to be given alongside standard heart surgery (list of clinical trials).
Two trials were recently completed: a phase 2b trial for frailty and a phase 1 trial for Alzheimer’s disease, which, according to a press release, showed positive results, with the low-dose arm slowing cognitive decline and improving quality-of-life metrics compared to placebo. A phase 2 trial for Alzheimer’s will start later in 2021, while results from the phase 2b frailty trial are expected in Q3 2021.
Allogeneic cells, which come from outside donors, have often been reported to stimulate an immune response, causing the body’s native cells to attack the foreign transplant, and this is why whole-organ transplants often require immunosuppressant drugs to be effective. However, as a CRATUS study has shown, the allogeneic cells that are used in these therapies seldom provoke any negative immune response.
Longeveron’s stem cell therapies are based on the CRATUS work on MSCs, and the lead CRATUS researcher, Dr. Joshua Hare, is the chief scientific officer and co-founder of Longeveron.