Abstract
Background: IPF is a chronic, progressive, lethal fibrotic lung disease of unknown etiology and treatment yet ineffective. The aim of the study was to investigate the safety and efficacy of endobronchial autologous infusion of adipose-derived mesenchymal stem cells (ADMSCs) in patients with IPF.
Methods: We performed a prospective, non-randomized trial of endobronchial autologous ADMSCs in IPF patients who met ATS/ERS 2000 criteria with mild to moderate lung disease as assessed by Forced vital capacity (FVC) >50% and diffusion capacity of the lung for carbon monoxide (DLCO) >35%. All eligible patients (n=14) underwent lipoaspiration and ADMSCs were isolated using a standard protocol provided by Adistem Ltd. ADMSCs were labelled with Technetium (Tc)-99m and endobronchially infused to both lower lobes.Tc-99m lung scanning was performed to visualize infused cells. The primary end point was incidence of treatment-emergent adverse events within 6 months after first infusion. FVC, DLCO and 6-minute walking distance (6MWD), were exploratory efficacy end points.
Results: No cases of clinically significant allergic reactions, disease acute exacerbation or infection were recorded in all patients. There were no significant alterations in FVC and DLCO 6 months post-treatment, though an almost marginal trend towards improvement in 6MWD (p=0.07) was reported.
Conclusions: This ongoing clinical trial provides pivotal safety and provisional efficacy data for endobronchial autologous infusion of ADMSCs in patients with IPF. Larger studies are sorely needed.
- © 2011 ERS