STEM CELLS SHOW PROMISE IN THE TREATMENT OF FRAILTY
April 14, 2017
Stem cells from healthy young donors, delivered via intravenous infusion to frail older adults, were shown to reduce inflammation in a small pilot study reported today at the International Conference on Frailty and Sarcopenia Research (ICFSR). These findings suggest that stem cells may have the potential to reverse some of the most debilitating effects of aging that result from chronic inflammation and a decline in immune function
BARCELONA, SPAIN, April 14, 2017. Stem cells from healthy young donors, delivered via intravenous infusion to frail older adults, were shown to reduce inflammation in a small pilot study reported today at the International Conference on Frailty and Sarcopenia Research (ICFSR). These findings suggest that stem cells may have the potential to reverse some of the most debilitating effects of aging that result from chronic inflammation and a decline in immune function.
Frailty, a multi-system syndrome that reflects decreased resilience to a range of stressors, has been increasingly recognized as a major cause of functional decline and adverse health outcomes in older adults. Chronic inflammation and other impairments in the immune system are thought to play a major role in the development of frailty. Adult stem cells derived from bone marrow – called mesenchymal stem cells (MSCs) — have been shown to have potent anti-inflammatory properties. This trial tested the hypothesis that MSCs from the bone marrow of healthy young donors (called allogeneic cells – allo-hMSCs — because they come from an unrelated donor) would reduce inflammation and improve function in frail older adults.
The trial enrolled 15 participants, aged 60-95, who met frailty criteria established by the Canadian Study on Health and Aging. Participants were randomized into three groups that received intravenous infusions of 20, 100, or 200 million allo-hMSCs. The infusions were well tolerated, with no treatment-related serious adverse events. Blood tests at baseline and at 6 and 12 months after the infusions showed a dose-related reduction in markers of inflammation as well as a decreased number of “exhausted” B cells. B cells are the immune cells responsible for producing antibodies in response to infection, and the exhaustion of B cells along with age-related declines in other aspects of immune function results in “immunosenescence,” characterized by impaired response to vaccines and increased susceptibility to infections. Since the group receiving 100 million allo-hMSCs showed the best response, a second infusion at that dose was given at 12 months, resulting in continued improvement of inflammatory and immune markers and suggesting a revitalization of the immune system.
The investigators will present additional data from this study – including data on changes in physical function and quality of life — at a poster session on Saturday, April 29th, at 10:30 a.m. Building on the positive results in the pilot study, the team moved on to a larger, randomized placebo controlled trial. Results of that study will be published in the near future in the Journal of Gerontology.
Co-authors of this study (www.clinicaltrials.gov: #NCT02065245) include Principal Investigator Joshua M. Hare, MD, Chief Science Officer of Longeveron and Director of the Interdisciplinary Stem Cell Institute (ISCI) at the University of Miami Miller School of Medicine ; Audrey S. Medina and Anthony A. Oliva, PhD from Longeveron; Aisha Khan from ISCI; and Pascal Goldschmidt-Clermont, from the division of cardiology at the University of Miami Miller School of Medicine. Longeveron is a regenerative medicine company which focuses on disease of aging, including Alzheimer’s disease, Aging Frailty, and the Metabolic Syndrome
Longeveron is researching treatments based on its Mesenchymal Stem Cells for a variety of aging-related diseases. In 2017, Longeveron published positive Phase I and Phase 2 clinical studies in the Journals of Gerontology that evaluated the safety and efficacy of its Mesenchymal Stem Cells in patients with Aging Frailty, a serious geriatric syndrome that can lead to other severe health conditions, such as heart disease. The company is now recruiting for an expanded Phase 2b Aging Frailty study.
Longeveron is also recruiting for a Phase 1 Alzheimer’s trial, and Phase 1 and 2 trials to evaluate the safety and efficacy of its stem cells for improving flu vaccine immune response in Aging Frailty patients. Longeveron’s MSC product is derived from the bone marrow of young, healthy adult donors.
Longeveron (www.longeveron.com) is a regenerative medicine therapy company founded in 2014. Longeveron’s goal is to provide the first of its kind biological solution for aging-related diseases, and is dedicated to developing safe cell-based therapeutics to revolutionize the aging process and improve quality of life. The company’s research focus areas Aging Frailty, the Metabolic Syndrome and Alzheimer’s Disease and gratefully acknowledges the generous support of the National Institutes of Health, the Alzheimer’s Association and Maryland Stem Cell Research Fund. Longeveron is also conducting a Phase 1 trial to study Hypoplastic Left Heart Syndrome, a rare indication that affects infants, supported through a grant from the Maryland Stem Cell Research Fund.
For more information about the clinical trials
Longeveron is sponsoring, visit ClinicalTrials.gov
SOURCE Longeveron LLC