Stem cell therapy for idiopathic pulmonary fibrosis: a protocol proposal

Journal of Translational Medicine

Protocol

Despoina Kakagia¹  Vassilis Paspaliaris²  George Koliakos³  Ioannis Kotsianidis⁴  Athanassios Zissimopoulos⁵  Marios Froudarakis⁶  Demosthenes Bouros⁶  Argyris Tzouvelekis⁶  Anastasia Oikonomou⁷  Paschalis Ntolios⁸  Irene Baira⁸  George Kolios⁸  Evangelos Bouros⁸ 

[1] 1st Department of Gebneral Surgery, Medical School, Democritus University of Thrace, Alexandroupolis, Greece;Adistem Ltd., Wanchai, Hong Kong;Department of Biochemistry, Medical School, Aristotle's University of Thessaloniki, Greece;Department of Hematology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece;Department of Nuclear Medicine, Medical School, Democritus University of Thrace, Alexandroupolis, Greece;Department of Pneumonology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece;Department of Radiology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece;Laboratory of Pharmacology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece;

关键词: stem cells;    adipose tissue;    stromal vascular fraction;    idiopathic pulmonary fibrosis;    therapy;    endobronchial infusion;    prospective;    nonrandomized phase Ib clinical trial;   

DOI  :  10.1186/1479-5876-9-182

 received in 2011-08-15, accepted in 2011-10-21,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundIdiopathic pulmonary fibrosis represents a lethal form of progressive fibrotic lung disorder with gradually increasing incidence worldwide. Despite intense research efforts its pathogenesis is still elusive and controversial reflecting in the current disappointing status regarding its treatment. Patients and Methods: We report the first protocol proposal of a prospective, unicentric, non-randomized, phase Ib clinical trial to study the safety and tolerability of the adipose-derived stem cells (ADSCs) stromal vascular fraction (SVF) as a therapeutic agent in IPF. After careful patient selection based on functional criteria (forced vital capacity-FVC > 50%, diffuse lung capacity for carbon monoxide-DLCO > 35% of the predicted values) all eligible subjects will be subjected to lipoaspiration resulting in the isolation of approximately 100- 500 gr of adipose tissue. After preparation, isolation and labelling ADSCs-SVF will be endobronchially infused to both lower lobes of the fibrotic lungs. Procedure will be repeated thrice at monthly intervals. Primary end-point represent safety and tolerability data, while exploratory secondary end-points include assessment of clinical functional and radiological status. Results: Preliminary results recently presented in the form of an abstract seem promising and tantalizing since there were no cases of clinically significant allergic reactions, infections, disease acute exacerbations or ectopic tissue formation. In addition 6 months follow-up data revealed a marginal improvement at 6-minute walking distance and forced vital capacity.ConclusionsAdipose tissue represents an abundant, safe, ethically uncontested and potentially beneficial source of stem cells for patients with IPF. Larger multicenter phase II and III placebo-controlled clinical trials are sorely needed in order to prove efficacy. However, pilot safety studies are of major importance and represent the first hamper that should be overcome to establish a rigid basis for larger clinical trials.

【 授权许可】

Unknown   
© Tzouvelekis et al; licensee BioMed Central Ltd. 2011. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.