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Clinical Trial
. 2018 Jun;12(6):2084-2089.
doi: 10.1111/crj.12777. Epub 2018 Mar 12.

Longitudinal outcomes of patients enrolled in a phase Ib clinical trial of the adipose-derived stromal cells-stromal vascular fraction in idiopathic pulmonary fibrosis

Paschalis Ntolios  1 , Eleni Manoloudi  1 , Argyris Tzouvelekis  2 , Evangelos Bouros  2 , Pachalis Steiropoulos  1 , Stavros Anevlavis  1 , Demosthenes Bouros  2 , Marios E Froudarakis  1
Affiliations
Clinical Trial

Longitudinal outcomes of patients enrolled in a phase Ib clinical trial of the adipose-derived stromal cells-stromal vascular fraction in idiopathic pulmonary fibrosis

Paschalis Ntolios et al. Clin Respir J. 2018 Jun.

Abstract

Background and objective: Cell-based therapies have been used for the management of several diseases, holding promising results. Few studies have evaluated their use in chronic lung diseases. Idiopathic pulmonary fibrosis (IPF) remains a lethal disease although new therapies have emerged the recent years. We have recently published a phase I study of 14 patients receiving endobronchially adipose-derived stem cells (ADSCs). The aim of this report is to assess the outcome for our patients' population.

Patients and methods: Patients who originally participated in this phase I study were followed up until the time of death. Pulmonary function tests as well as disease progression and survival time points were recorded.

Results: After first administration, a significant functional decline was observed as assessed by the changes (delta-Δ) of diffusion capacity for carbon monoxide (DLco) (mean ΔDLco = 6.2%, P = .04) and forced vital capacity (FVC) (mean ΔFVC = 6%, P = .029) at 18 and at 24 months, respectively. Median overall progression-free survival was 26 months and median overall survival was 32 months. All patients were alive for at least 2 years (survival rate, 100%) after first administration. Twelve patients (85.7%) died owing to disease progression. None of the patients experienced tumor development.

Conclusions: Significant functional decline occurred at 24 months after first administration. The median survival and time to progression are in line with the published epidemiologic data. Further clinical trials complemented by mechanistic studies are sorely needed to delineate the role of ADSCs in IPF pathogenesis and treatment.

Keywords: IPF; clinical trial; follow-up; idiopathic; pulmonary fibrosis; stem cells; survival.

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