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Enrollment Completed in Aging Frailty Stem Cell Trial

Hands of older person

(Steve Buissinne, Pixabay)

13 Feb. 2020. A company developing stem cell treatments to counter frailty in older people finished enlisting participants in a clinical trial testing its therapies. Longeveron LLC in Miami is conducting the mid-stage trial with 150 individuals at seven test sites in Florida.

Longeveron develops therapies for age-related diseases from human mesenchymal stem cells. Mesenchymal stem cells are so-called adult stem cells, derived from existing cells or tissue, in this case, bone marrow, rather than human embryos. Longeveron acquires donated bone marrow from young, healthy volunteers, then processes the donations in the company’s lab to extract stem cells for allogenic, or off-the-shelf infusions in patients. The company is creating treatments from these stem cells for frailty, metabolic disorder, and Alzheimer’s disease in older individuals, as well as congenital heart defects in children.

Frailty in older adults, usually people older than 65, is recognized as a geriatric syndrome indicated by weakness, low activity, and weight loss. The condition helps make older individuals vulnerable to other diseases, by lowering their ability to counter internal stresses. “The biology of frailty is complex,” says Anthony Oliva, senior scientist at Longeveron in a company statement released through PRNewswire, “and includes diminished stem cell activity, reduced ability to repair and regenerate tissue, and chronic systemic inflammation.”

Longeveron says its stem cell infusions restore stem cell levels to help reduce inflammation, promote internal tissue repair, and improve immune system performance. As a result, the company believes its treatments can help people in frail condition, estimated at 7 to 12 percent of people age 65 and older, increase their strength, stamina, and mobility. Longeveron says earlier clinical trials established the safety of its stem cell treatments.

The new clinical trial is testing Longeveron’s stem cell treatments among 150 older individuals, age 70 to 85, and scored mildly or moderately frail on a standard rating scale. Participants are randomly assigned to receive one of four doses — 25, 50, 100, or 200 million –stem cells, or a placebo, in a single infusion. The study team is looking primarily at the distance participants can walk for six minutes before stem cell or placebo infusions, and 180 days later. Participants are also rated on changes in overall physical functioning, as well as levels of an inflammatory cytokine called tumor necrosis factor alpha, or TNF alpha.

“This study,” says Longeveron’s president Geoff Green, “is designed to determine whether the transplant of healthy donor-derived mesenchymal stem cells can restore mild to moderately frail patients to a state of more healthful aging, thereby improving functionality and lowering their risk of disability, and dependence on others for care.”

The clinical trial is funded by a Small Business Innovation Research, or SBIR, grant from National Institute on Aging, part of National Institutes of Health. Funding from the grant, awarded in October 2018, is set to end on 29 February 2020.

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