Allogeneic Human Cells (hMSC)in Patients With Idiopathic Pulmonary Fibrosis Via Intravenous Delivery (AETHER)

NCT02013700 ↗

Phase 1 Terminated 9 enrolled Joshua M Hare The Emmes Company, LLC · collab The Lester And Sue Smith Foundation · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

This is a phase I, randomized, blinded, placebo-controlled 9 subjects pilot safety run-in followed by an additional 16 randomized subjects for a total of 25 subjects. In the pilot phase subjects will be randomized into three treatment groups of allogenic mesenchymal stem cells and in the randomized phase subjects will receive either allogenic mesenchymal stem cells or matched placebo.

Timeline

Start: 2013-11-13
Primary completion: 2015-12-11
Completion: 2016-11-24

Outcome

Outcome not reported

Stopped: “Study completed”

Publications

Background Glassberg MK, Minkiewicz J, Toonkel RL, Simonet ES, Rubio GA, DiFede D, Shafazand S, Khan A, Pujol MV, LaRussa VF, Lancaster LH, Rosen GD, Fishman J, Mageto YN, Mendizabal A, Hare JM. Allogeneic Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER): A Phase I Safety Clinical Trial. Chest. 2017 May;151(5):971-981. doi: 10.1016/j.chest.2016.10.061. Epub 2016 Nov 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Allogeneic Adult Human Mesenchymal Stem Cells	Cell therapy	2e+07 cells	Intravenous
Subject	Allogeneic Adult Human Mesenchymal Stem Cells	Cell therapy	1e+08 cells	Intravenous
Subject	Allogeneic Adult Human Mesenchymal Stem Cells	Cell therapy	2e+08 cells	Intravenous