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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis (IPF)

In brief

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.

Key facts

Study ID

NCT02013700

Run by

Joshua M Hare

People needed

9

Starts

2013-11-13

Expected to finish

2016-11-24

Last updated by the study team

2021-03-09

Who can join

Age: 40 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Provide written informed consent.
• Subjects age equal to or greater than 40 and equal to or less than 90 years at the time of signing the Informed Consent Form.
• Have a clinical diagnosis of Idiopathic Pulmonary Fibrosis (IPF) prior to screening
• Forced vital capacity (FVC) ≥ 50% predicted and diffusing capacity (DLCO) ≥30% (corrected for hemoglobin but not alveolar volume).
• RVSP equal to or less than 50 mmHg, as documented by Doppler echo or right heart catheterization.
• Female subjects must be surgically sterile or post-menopausal (greater than 1 year).

You may not qualify if…

• HRCT and/or surgical lung biopsy results inconsistent with the diagnosis of IPF.
• Infiltrative lung disease of any type other than Idiopathic Pulmonary Fibrosis (IPF), lungs disease related to fibrogenic agents, toxins, drugs or other exposures, granulomatous lung disease, pulmonary vascular disease, or known connective tissue disease.
• Inability to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform pulmonary function tests or high resolution CT (HRCT), undergo blood draws, read and respond to questionnaires.
• Currently receiving (or received within four weeks of screening) any medication, treatment, or experimental agents for the treatment of Idiopathic Pulmonary Fibrosis (IPF), except for patients receiving non drug therapies will include oxygen saturation therapy (oxygen supplementation) and pulmonary rehabilitation.
• Active listing (or expected future listing) for transplant of any organ.
• Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin <8 g/dl, white blood cell count <3000/mm3, platelets <80,000/mm3, INR > 1.5, aspartate transaminase, alanine transaminase, or alkaline phosphatase > 3 times upper limit of normal, total bilirubin > 1.5 mg/dl.
• Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. Including, but not limited to: HIV, advanced liver or renal failure, class III/IV congestive heart failure, myocardial infarction, unstable angina, or cardiac revascularization within the last six months, or severe obstructive ventilatory defect.
• Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
• Have known allergies to penicillin or streptomycin.
• Be an organ transplant recipient.
• Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively- treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
• Have a non-pulmonary condition that limits lifespan to less than 1 year.
• Have a history of drug or alcohol abuse within the past 24 months.
• Be serum positive for Human immunodeficiency virus (HIV), hepatitis BsAg or Viremic hepatitis C.
• Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
• Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to injection.
• Female subjects must have a FSH less than 25.8 IU/L
• Subject with hypersensitivity to dimethyl sulfoxide (DMSO)
• Saturated oxygen (SpO2 of less than 93% (room air [sea level] at rest). SpO2 of less than 88% (room air [>5,000 feet above sea level (1524 meters) at rest).

Where it is running

• Interdisciplinary Stem Cell Institute / University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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