Purpose:
To demonstrate the safety and efficacy of autologous Lung Spheroid Stem Cells (LSCs)
administered by intravenous infusion in patients with idiopathic pulmonary fibrosis
Progressive Fibrotic Interstitial Lung Disease.
Participants:
Patients with Idiopathic Pulmonary Fibrosis (IPF) and Progressive Fibrotic Interstitial Lung
Disease
Procedures (methods):
24 patients previously diagnosed with idiopathic pulmonary fibrosis or Progressive Fibrotic
Interstitial Lung Disease 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.
Type: Interventional
Start Date: Oct 2020
open study
