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

Chambers, Daniel C., Enever, Debra, Ilic, Nina, Sparks, Lisa, Whitelaw, Kylie, Ayres, John, Yerkovich, Stephanie T., Khalil, Dalia, Atkinson, Kerry M. and Hopkins, Peter M. A. (2014) A phase 1b study of placenta-derived mesenchymal stromal cells in patients with idiopathic pulmonary fibrosis. Respirology, 19 7: 1013-1018. doi:10.1111/resp.12343


Author Chambers, Daniel C.
Enever, Debra
Ilic, Nina
Sparks, Lisa
Whitelaw, Kylie
Ayres, John
Yerkovich, Stephanie T.
Khalil, Dalia
Atkinson, Kerry M.
Hopkins, Peter M. A.
Title A phase 1b study of placenta-derived mesenchymal stromal cells in patients with idiopathic pulmonary fibrosis
Journal name Respirology   Check publisher's open access policy
ISSN 1323-7799
1440-1843
Publication date 2014-01-01
Year available 2014
Sub-type Article (original research)
DOI 10.1111/resp.12343
Volume 19
Issue 7
Start page 1013
End page 1018
Total pages 6
Place of publication Richmond, VIC Australia
Publisher Wiley-Blackwell Publishing Asia
Collection year 2015
Language eng
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 1×106 (n=4) or 2×106 (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 15min, 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.
Keyword Cell therapy
Idiopathic pulmonary fibrosis
Infusion
Mesenchymal stromal cells
Short term safety
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

Document type: Journal Article
Sub-type: Article (original research)
Collections: UQ Centre for Clinical Research Publications
Official 2015 Collection
School of Medicine Publications
 
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