A phase 1b study of placenta-derived mesenchymal stromal cells in patients with idiopathic pulmonary fibrosis

Chambers, Daniel, Enever, Debra, Ilic, Nina, Sparks, Lisa, Whitelaw, Kylie, Ayres, John, Yerkovich, Stephanie, Khalil, Dalia, Atkinson, Michael, & Hopkins, Peter (2014) A phase 1b study of placenta-derived mesenchymal stromal cells in patients with idiopathic pulmonary fibrosis. Respirology, 19(7), pp. 1013-1018.

View at publisher

Abstract

BACKGROUND AND OBJECTIVE:

Idiopathic pulmonary fibrosis (IPF) is a degenerative disease characterized by fibrosis following failed epithelial repair. Mesenchymal stromal cells (MSC), a key component of the stem cell niche in bone marrow and possibly other organs including lung, have been shown to enhance epithelial repair and are effective in preclinical models of inflammation-induced pulmonary fibrosis, but may be profibrotic in some circumstances.

METHODS:

In this single centre, non-randomized, dose escalation phase 1b trial, patients with moderately severe IPF (diffusing capacity for carbon monoxide (DLCO ) ≥ 25% and forced vital capacity (FVC) ≥ 50%) received either 1 × 10(6) (n = 4) or 2 × 10(6) (n = 4) unrelated-donor, placenta-derived MSC/kg via a peripheral vein and were followed for 6 months with lung function (FVC and DLCO ), 6-min walk distance (6MWD) and computed tomography (CT) chest.

RESULTS:

Eight patients (4 female, aged 63.5 (57-75) years) with median (interquartile range) FVC 60 (52.5-74.5)% and DLCO 34.5 (29.5-40)% predicted were treated. Both dose schedules were well tolerated with only minor and transient acute adverse effects. MSC infusion was associated with a transient (1% (0-2%)) fall in SaO2 after 15 min, but no changes in haemodynamics. At 6 months FVC, DLCO , 6MWD and CT fibrosis score were unchanged compared with baseline. There was no evidence of worsening fibrosis.

CONCLUSIONS:

Intravenous MSC administration is feasible and has a good short-term safety profile in patients with moderately severe IPF.

Impact and interest:

35 citations in Scopus
31 citations in Web of Science®
Search Google Scholar™

Citation counts are sourced monthly from Scopus and Web of Science® citation databases.

These databases contain citations from different subsets of available publications and different time periods and thus the citation count from each is usually different. Some works are not in either database and no count is displayed. Scopus includes citations from articles published in 1996 onwards, and Web of Science® generally from 1980 onwards.

Citations counts from the Google Scholar™ indexing service can be viewed at the linked Google Scholar™ search.

ID Code: 88689
Item Type: Journal Article
Refereed: Yes
Keywords: cell therapy, idiopathic pulmonary fibrosis, infusion, mesenchymal stromal cells, short-term safety
DOI: 10.1111/resp.12343
ISSN: 1323-7799
Copyright Owner: © 2014 Asian Pacific Society of Respirology
Deposited On: 02 Nov 2015 00:46
Last Modified: 02 Nov 2015 00:46

Export: EndNote | Dublin Core | BibTeX

Repository Staff Only: item control page