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NCT02013700: AETHER

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

Terminated Phase 1 Last updated 9 March 2021
What this trial tests

Phase 1 trial testing Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs) in Idiopathic Pulmonary Fibrosis (IPF) in 9 participants. Terminated before completion.

Timeline
13 November 2013
Primary endpoint
11 December 2015
24 November 2016

Quick facts

Lead sponsorJoshua M Hare
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment9
Start date13 November 2013
Primary completion11 December 2015
Estimated completion24 November 2016
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Joshua M Hare — full company profile →

Who can join

Adults 40 to 90, any sex, with Idiopathic Pulmonary Fibrosis (IPF). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Allogeneic Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER): A Phase I Safety Clinical Trial.
    Glassberg MK, Minkiewicz J, Toonkel RL, Simonet ES, et al · · 2017 · cited 191× · PMID 27890713 · DOI 10.1016/j.chest.2016.10.061
  2. Mesenchymal Stem Cell-Based Therapy of Inflammatory Lung Diseases: Current Understanding and Future Perspectives.
    Harrell CR, Sadikot R, Pascual J, Fellabaum C, et al · · 2019 · cited 144× · PMID 31191672 · DOI 10.1155/2019/4236973
  3. Mesenchymal Stromal Cells in Animal Bleomycin Pulmonary Fibrosis Models: A Systematic Review.
    Srour N, Thébaud B. · · 2015 · cited 87× · PMID 26494779 · DOI 10.5966/sctm.2015-0121
  4. Mesenchymal stem cells in fibrotic diseases-the two sides of the same coin.
    Qin L, Liu N, Bao CL, Yang DZ, et al · · 2023 · cited 74× · PMID 35896695 · DOI 10.1038/s41401-022-00952-0
  5. Regulatory Immune Cells in Idiopathic Pulmonary Fibrosis: Friends or Foes?
    van Geffen C, Deißler A, Quante M, Renz H, et al · · 2021 · cited 65× · PMID 33995390 · DOI 10.3389/fimmu.2021.663203
  6. Therapeutic Applications of Mesenchymal Stem Cells in Idiopathic Pulmonary Fibrosis.
    Yang S, Liu P, Jiang Y, Wang Z, et al · · 2021 · cited 45× · PMID 33768094 · DOI 10.3389/fcell.2021.639657
  7. Targeting Alveolar Repair in Idiopathic Pulmonary Fibrosis.
    Ptasinski VA, Stegmayr J, Belvisi MG, Wagner DE, et al · · 2021 · cited 43× · PMID 34129811 · DOI 10.1165/rcmb.2020-0476tr
  8. Effects of Mesenchymal Stromal Cell-Derived Extracellular Vesicles in Lung Diseases: Current Status and Future Perspectives.
    Guo H, Su Y, Deng F. · · 2021 · cited 42× · PMID 33211245 · DOI 10.1007/s12015-020-10085-8

Verify or expand the search:

Other recruiting trials for Idiopathic Pulmonary Fibrosis (IPF)

Currently open trials in the same condition.

Other Joshua M Hare trials

Trials by the same sponsor.

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Data sources for this page

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