Frailty, a geriatric syndrome characterized by a decline in various physiological reserves and functions, is a significant health concern in our aging population. It's associated with a host of negative health outcomes, including falls, hospitalization, disability, and even death. However, recent research has shed light on a promising new treatment for frailty: intravenous mesenchymal stem cells (IV MSCs).
Frailty is a complex syndrome that affects multiple body systems. It's marked by decreased lean body mass, strength, endurance, balance, gait speed, activity and energy levels, and organ physiologic reserve. These changes lead to a loss of homeostasis and increased vulnerability to stressors.
Frailty is strongly linked with chronic diseases and degenerative conditions. It's also associated with inflammation and an impaired ability to repair tissue injury due to decreases in endogenous stem cell production.
Mesenchymal stem cells (MSCs) are a type of stem cell that can differentiate into various cell types, including those that make up bone, cartilage, muscle, and fat tissue. They also have immunomodulatory and anti-inflammatory effects, making them a promising therapeutic option for conditions characterized by inflammation and tissue damage, such as frailty.
Recent studies have explored the use of MSCs in treating frailty, focusing on their potential to contribute to cellular repair and tissue regeneration. These studies have shown that intravenously delivered allogeneic MSCs are safe and produce significant improvements in physical performance measures and inflammatory biomarkers.
In a phase I trial, 15 patients diagnosed with frailty received allogeneic MSCs by intravenous infusion at doses of 20, 100, or 200 million MSCs. The primary outcome was the incidence of any treatment-emergent serious adverse events (TE-SAEs) at 1 month post-infusion. The secondary outcomes were physical function measurements and circulating inflammatory biomarkers, measured at 3 and 6 months post-infusion. The study indicated that allogeneic infusion of MSCs is safe and immunologically tolerated in aging frailty patients.
Following the promising results of the phase I trial, a phase II trial was conducted. This was a randomized, double-blinded, dose-finding study of intravenous allogeneic MSCs at doses of 100 or 200 million compared to placebo in 30 frailty patients. The primary outcome was safety, namely the incidence of TE-SAEs at 1-month post-infusion. The secondary outcomes were physical performance measures, patient-reported quality outcomes, and immune markers of frailty, measured at 6 months post-infusion. The study found that intravenous allogeneic MSCs were safe in individuals with aging frailty and produced significant benefits in measures of physical performance as well as inflammatory biomarkers.
Given the excellent safety profile and promising therapeutic efficacy demonstrated in these early phase trials, studies with repeat dosing and longer follow-up time, as well as, a larger phase IIb clinical trial are ongoing to establish the efficacy of MSCs in the frailty syndrome.
Allogeneic therapy was used in these studies because it offers "off-the-shelf" availability and a consistency to the cell product. These properties are extremely important as autologous cells may have deficiencies in function due to the underlying disease process, co-morbidities, lifestyle, concomitant medications, and/or patient age.
Intravenous mesenchymal stem cells offer a promising new approach to treating frailty, a complex and challenging health issue in our aging population. While further research is needed to fully understand and optimize this treatment, the results so far are encouraging. As our understanding of MSCs and their potential applications continues to grow, so too does our hope for effective treatments for frailty and other age-related conditions.
Stay tuned for more updates on this exciting area of research, and remember – aging doesn't have to mean frailty. With the right treatments and care, we can all look forward to healthier, more vibrant golden years.
Reference:
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6249304/pdf/fnut-05-00108.pdf
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