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 and a phase 2b trial for metabolic syndrome (list of clinical trials).
Three trials were recently completed: a Phase 2b trial for frailty, a Phase 1 trial for Alzheimer’s disease, and a phase 1 trial for hypoplastic left heart syndrome in infants to be given alongside standard heart surgery. The phase 2b frailty trial showed, according to a press release, a non-statistically significant increase in the six-minute walk test after 6 months, with patients with the highest dose of 200 million cells increasing the distance walked by 41 meters compared to placebo.
According to an April 2021 press release, the Phase 1 trial for Alzheimer’s disease 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. In November 2021, it was announced that a sponsored clinical research agreement with the National Center for Geriatrics and Gerontology (NCGG) and Juntendo University Hospital in Japan had been reached for a Phase 2 trial to test for safety and efficacy in older and frail subjects.
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 the 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.
Longeveron has sponsored a Treatment Registry Trial in the Bahamas, which eligible patients can take part in at their own expense.