Safety study of autologous adult bone marrow derived mesenchymal stromal cells in idiopathic pulmonary fibrosis - Pilot data

Abstract

BackgroundLung transplantation is the choice of therapy in severe cases of idiopathic pulmonary fibrosis (IPF) but is compounded with post-transplant complications. The paucity of deceased organ donations underlines the need for alternate approaches that improves the quality of life. Herein, we attempted to develop an autologous adult bone marrow derived mesenchymal stromal cell (BMSC) therapy via central line access, and evaluated the safety of a single dose (~13 × 106cells/mL), in treating “no option” IPF. MethodThe study included severe IPF subjects (n = 6) both male and female, aged 40–70 years of age with a forced vital capacity <50%, diffusing capacity of lung for carbon monoxide (DLco) <35% of predicted, and/or oxygen (SpO2) saturation <88% on 6min walk distance (6 MWD). BMSCs at passage 2 were suspended in 30.0mL normal saline and dispensed through the central line route in a respiratory intensive care unit of Gleneagles Global Hospitals. The subjects were monitored for the first 24h for serious adverse events and hemodynamic parameters. They were followed up periodically at intervals of 1, 4, and 9 months for safety and monitoring of adverse events, including secondary objectives of changes in pulmonary function test, DLco, 6 MWD, and quality of life as per the study protocol. ResultsIt was observed that central line infusions were well tolerated by all subjects. Furthermore, there was an improved quality of life. ConclusionsBMSC central line infusion in “no option” IPF cases provided an insight into the strategies in improving the quality of life for patient and thereby increasing the therapeutic window period for lung transplantation.