Human Autologous Lung Stem Cell Transplant for Idiopathic Pulmonary Fibrosis (HALT-IPF)

  • STATUS
    Recruiting
  • End date
    Oct 1, 2024
  • participants needed
    24
  • sponsor
    University of North Carolina, Chapel Hill
Updated on 15 May 2022
ct scan
pneumonia
carbon monoxide
6-minute walk test
idiopathic pulmonary fibrosis
walk tests
forced vital capacity
lung biopsy
diffusion capacity of the lung for carbon monoxide

Summary

Purpose

To demonstrate the safety and efficacy of autologous Lung Spheroid Stem Cells (LSCs) administered by intravenous infusion in patients with idiopathic pulmonary fibrosis.

Participants

Patients with Idiopathic Pulmonary Fibrosis (IPF)

Procedures (methods):

24 patients previously diagnosed with idiopathic pulmonary fibrosis meeting all inclusion/exclusion criteria will be evaluated at baseline. LSCs will be grown from autologous trans-bronchial pulmonary biopsy specimens. The first group, consisting of 6 patients will be randomized after completion of the screening procedures to either a treatment group of 100 million LSCs administered via intravenous infusion or to a control group (standard care) in a 2:1 LSC to control group ratio. The second group of 18 patients will be randomized after completion of the screening procedures to either a treatment group of 200 million LSCs administered via intravenous infusion or to a control group (standard care) in a 2:1 LSC to control group ratio. Patients will be randomized using permuted blocks in a 2:1 LSC to control group ratio, providing a distribution of 8:4:12 patients among the control, low dose, and high dose groups, respectively. If the patient is randomized and 100 million LSCs are not achieved, then the patient will be analyzed separately and another patient enrolled. Intravenous infusion of LSCs will take place 4-8 weeks after the pulmonary biopsies are obtained. All patients will be followed up at months 0.5, 1, 3, 6, 9, 12, 18, and 24 after infusion to complete the safety and efficacy assessments listed herein. All patients will receive standard of care for their IPF.

Details
Condition Idiopathic Pulmonary Fibrosis
Treatment Lung Spheroid Stem Cells 100 million, Lung Spheroid Stem Cells 200 million
Clinical Study IdentifierNCT04262167
SponsorUniversity of North Carolina, Chapel Hill
Last Modified on15 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female between the ages of 50 to 80
Diagnosis of IPF based on the following criteria in accordance with American Thoracic Society (ATS) guidelines for diagnosing IPF
Definite usual interstitial pneumonia (UIP) confirmed on surgical lung biopsy (SLB) with all other etiologies for UIP excluded OR High resolution CT scan (HRCT) showing definite UIP with all other etiologies for UIP excluded
Probable UIP on both imaging and surgical lung biopsy with all other etiologies for UIP excluded
Forced vital capacity (FVC) greater than 50% of predicted with a ratio of forced
Diffusing capacity for carbon monoxide (DLCO) greater than 25% of predicted capacity
expiratory volume in 1 second to FVC (FEV1/FVC) greater than 0.75 (Pulmonary
Ability to perform a 6-Minute Walk Test (6MWT) at screening
function tests must be completed no more than 90 days before screening)
Competency to understand the information given in the Human Research and Ethics Committee (HREC) approved Informed Consent Form and must sign the form prior to the initiation of any study procedures

Exclusion Criteria

Diagnosis of an interstitial lung disease (ILD) or restrictive lung disease other than IPF
Obstructive lung disease as determined by evidence of airflow obstruction on HRCT or physiologic criteria including: FEV1/FVC ratio less than 0.75, Residual volume (RV) greater than 120% by plethysmography or significant (verified by radiologist) emphysema on HRCT or evidence of reactive airway disease by change in FEV1 of greater than 12% following bronchodilator challenge
Evidence of sustained improvement of IPF condition defined as improvement from pre-therapy pulmonary function tests (PFTs) observed with two or more successive post-therapy PFTs over the year prior to randomization
Active or recent (less than 60 days prior to enrollment) significant respiratory tract infections, or a history of frequent (greater than 2 per year for the last 2 years) infective exacerbations of IPF
Hospitalization within 60 days of screening for an acute exacerbation of IPF (AE-IPF)
Chronic heart failure (NYHA class III/IV) or known left ventricular ejection fraction less
Subject requires hemodialysis, peritoneal dialysis or hemofiltration
than 45%
Infection with HIV
Acute or chronic impairment (other than dyspnea) which limits the ability to comply
Viral Hepatitis
with study requirements and procedures including the 6MWT
Resting oxygen requirements or >4 L of nasal canula oxygen needed with exertion
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