Adult stem cell therapy developer Longeveron has won a $3.8 million NIH Small Business Innovation Research (SBIR) grant for its research toward developing stem cell therapies for aging frailty.

Longeveron said it would apply the grant to the clinical research of its Mesenchymal Stem Cells (MSCs) as treatment for aging frailty, a geriatric syndrome of multisystem physiological decline distinct from normal aging that heightens vulnerability to adverse and serious health conditions in older people.

Longeveron’s MSC product is derived from the bone marrow of young, healthy adult donors. Last year, Longeveron published positive Phase I and Phase II clinical studies in the Journals of Gerontology that evaluated the safety and efficacy of its MSCs in patients with aging frailty. The company is now recruiting for an expanded Phase IIb aging frailty study (NCT03169231).

Longeveron is also recruiting for a Phase I trial assessing its MSCs in patients with clinically diagnosed Alzheimer’s disease (NCT02600130), and a Phase I/II trial evaluating the safety and efficacy of its stem cells for improving flu vaccine immune response in aging frailty patients (NCT02982915).

“There is growing awareness in the geriatric community to diagnose and treat this condition, as it is not an inevitable consequence of aging.  We believe a biologically-driven cell-based therapy could have a major beneficial impact,” Longeveron co-founder and CSO Joshua Hare, M.D., said in a statement.

Founded in 2014, Miami-based Longeveron is a regenerative medicine therapy company aiming to provide a first of its kind biological solution for aging-related diseases, by producing allogeneic MSCs from adult human bone marrow MSCs.

“Older hearts don’t work as well as younger hearts, all other things being equal. Therefore, we hypothesized that the decline in function was related to the depletion of normal adult stem cells in the body. Then we found a way to replete them. For us, it was a ‘Eureka!’ moment,” Dr. Hare told GEN earlier this year

The SBIR grant is the second NIH grant announced by Longeveron this year. On January 9, Longeveron said it had won a $1.15 million Small Business Technology Transfer grant under the NIH Fast Track program for small businesses toward developing therapeutics to combat metabolic syndrome.

In addition to the NIH grants, Longeveron this year was awarded a $750,000 grant from the Maryland Technology Development Corporation (TEDCO), announced May 22. The company earlier received financial support from the Alzheimer’s Association and TEDCO for clinical trials in Alzheimer’s disease and hypoplastic left heart syndrome, respectively.

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