New Japanese stem cell clinical trial for aging frailty

Longeveron announces Phase 2 clinical trial to evaluate the safety and efficacy of Mesenchymal Stem Cells (LMSCs) for the treatment of aging frailty in Japanese patients.

Aging frailty is a common life-threatening geriatric condition that affects millions of Japanese people over the age of 65. However, it is reversible.

Longevity.Technology: Frailty has been dismissed as a natural consequence of aging – our bodies just wear out, right? Wrong – decreasing stem cell levels impact the body’s abilities to repair itself, tackle inflammation and maintain a healthy immune system. This clinical trial puts aging frailty in the spotlight as part of the disease that is aging and shows it can be tackled and mitigated, rather than just accepted.

Frailty is a combination of conditions that can include muscle loss, decreased strength, limited mobility, sarcopenia, decreased energy, nutritional deficiencies, weight loss and fatigue. This puts the sufferer at increased risk of disability, dependency and death.

Japan has the world’s third-largest economy and a rapidly-aging population – it is estimated that by 2030, one in every three people in Japan will be 65 or older [1].

The new study will be a randomised, double-blind, placebo-controlled trial designed to use stem cells to make progress towards preventing and reversing the functional decline associated with frailty. It further enhances Longeveron‘s aging frailty programme, which includes two ongoing Phase 2 clinical trials in the US.

This new Phase 2 clinical trial to evaluate the safety and efficacy of Longeveron’s Mesenchymal Stem Cells (LMSCs) has been approved by Japan’s Pharmaceutical and Medical Devices Agency (PMDA) (the Japanese equivalent of the FDA). It will be conducted at Juntendo University Hospital in Tokyo and Japan’s National Center for Geriatrics and Gerontology (NCGG) in Nagoya.

Longeveron Allogeneic Mesenchymal Stem Cells (LMSCs) are a regenerative medical therapy; they are sourced from the bone marrow of young healthy adult donors, culture-expanded and then maintained as individual “off-the-shelf” doses.

“…multiple mechanisms of action … extremely attractive as a therapeutic candidate for the unmet medical need of Aging Frailty.”

“The biology of frailty is complex, and includes diminished stem cell activity, reduced ability to repair and regenerate tissue, and immunosenescence (deterioration of the immune system) and chronic systemic inflammation,” said Dr Anthony Oliva, Senior Scientist at Longeveron. “LMSCs have multiple mechanisms of action that can potentially address all of these issues, and thus make them extremely attractive as a therapeutic candidate for the unmet medical need of Aging Frailty [2].”

The study’s Principal Investigator, Dr Hidenori Arai, President of the NCGG, said: “Japan has one of the oldest and fastest aging societies in the world, with nearly 30% of Japan’s citizens over the age of 65. Preventing and reversing functional decline associated with frailty is one of the nation’s top priorities, and Longeveron’s regenerative medicine approach is an exciting and innovative potential therapeutic option. With the disproportionate infection and mortality rate of older people with COVID-19 and Influenza infection, it is critically important to rapidly test treatments that may be effective [3].”

[3] Ibid

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