Safety of IV Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis (IPF) remains an inexorably progressive and fatal disorder, with an overall incidence of roughly 94 cases per 100,000 person-years in the United States.1 The disease is characterized by ongoing lung injury with insidious deposition of extracellular matrix material leading to progressive distortion of lung architecture and subsequent loss of respiratory function. Traditional antiinflammatory therapies are well documented as having no efficacy for treating this condition and may, in fact, be associated with worse outcomes.2,3 The disease manifests as a relentless reduction in respiratory function, with interspersed episodes of rapidly progressive deterioration known as acute exacerbations. Despite the recent availability of two US Food and Drug Administration-approved antifibrotic agents for treating this disorder, no current medical therapies are known to be curative.4,5 In this light, continued investigation is desperately needed to develop new therapies to address this extremely devastating illness. Cell-based therapies, including the use of human mesenchymal stem cells (hMSCs) have been postulated as one such novel approach to treat IPF. Stem cells are proposed to target sites of ongoing tissue injury, to foster tissue regeneration and modulate lung remodeling, and to regulate pulmonary inflammation.6 The desperate nature of IPF and the promise of cell-based therapies have driven patients to seek out such treatment approaches even outside the confines of carefully controlled clinical studies, at times resulting in unfavorable outcomes. Accordingly, it remains imperative that the application of cell-based therapies for IPF be conducted only in carefully controlled clinical trial settings.

http://ift.tt/2pdsQh6