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

NCT02013700 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-03-09

No results posted yet for this study

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.

Conditions

  • Idiopathic Pulmonary Fibrosis (IPF)

Interventions

BIOLOGICAL

Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs)

BIOLOGICAL

matched placebo

The placebo will be 25 ml of Plasma-Lyte A with 1% HSA in a Cryostore bag.

Sponsors & Collaborators

  • The Lester And Sue Smith Foundation

    collaborator UNKNOWN

  • The Emmes Company, LLC

    collaborator INDUSTRY

  • Joshua M Hare

    lead OTHER

Principal Investigators

  • Marilyn K. Glassberg, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-13
Primary Completion
2015-12-11
Completion
2016-11-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02013700 on ClinicalTrials.gov