title: A prospective, non-randomized, no placebo-controlled, phase Ib clinical trial to study the safety of the adipose derived stromal cells-stromal vascular fraction in idiopathic pulmonary fibrosis.
abstract: BACKGROUND
  Regenerative medicine and particular adult stem cells represent an alternative option with several fruitful therapeutic applications in patients suffering from chronic lung diseases including idiopathic pulmonary fibrosis (IPF). Nevertheless, lack of knowledge regarding the origin and the potential of mesenchymal stem cells (MSCs) to differentiate into fibroblasts has limited their use for the treatment of this dismal disease.
  
  
  METHODS
  To this end, we conducted a phase Ib, non-randomized, clinical trial to study the safety of three endobronchial infusions of autologous adipose derived stromal cells (ADSCs)-stromal vascular fraction (SVF) (0.5 million cells per kgr of body weight per infusion) in patients with IPF (n=14) of mild to moderate disease severity (forced vital capacity -FVC>50% predicted value and diffusion lung capacity for carbon monoxide-DLCO>35% of predicted value). Our primary end-point was incidence of treatment emergent adverse events within 12 months. Alterations of functional, exercise capacity and quality of life parameters at serial time points (baseline, 6 and 12 months after first infusion) were exploratory secondary end-points.
  
  
  RESULTS
  No cases of serious or clinically meaningful adverse events including short-term infusional toxicities as well as long-term ectopic tissue formation were recorded in all patients. Detailed safety monitoring through several time-points indicated that cell-treated patients did not deteriorate in both functional parameters and indicators of quality of life.
  
  
  CONCLUSIONS
  The clinical trial met its primary objective demonstrating an acceptable safety profile of endobronchially administered autologous ADSCs-SVF. Our findings accelerate the rapidly expanded scientific knowledge and indicate a way towards future efficacy trials.
authors.affiliation: Department of Pneumonology, Medical School, Democritus University of Thrace, Alexandroupolis, Greece.
authors.forename: Argyris
authors.initials: A
authors.lastname: Tzouvelekis
authors.forename: Vassilis
authors.initials: V
authors.lastname: Paspaliaris
authors.forename: George
authors.initials: G
authors.lastname: Koliakos
authors.forename: Paschalis
authors.initials: P
authors.lastname: Ntolios
authors.forename: Evangelos
authors.initials: E
authors.lastname: Bouros
authors.forename: Anastasia
authors.initials: A
authors.lastname: Oikonomou
authors.forename: Athanassios
authors.initials: A
authors.lastname: Zissimopoulos
authors.forename: Nikolaos
authors.initials: N
authors.lastname: Boussios
authors.forename: Brian
authors.initials: B
authors.lastname: Dardzinski
authors.forename: Dimitrios
authors.initials: D
authors.lastname: Gritzalis
authors.forename: Antonis
authors.initials: A
authors.lastname: Antoniadis
authors.forename: Marios
authors.initials: M
authors.lastname: Froudarakis
authors.forename: George
authors.initials: G
authors.lastname: Kolios
authors.forename: Demosthenes
authors.initials: D
authors.lastname: Bouros
mesh_terms: D000273:Adipose Tissue / Q000166:cytology*; D000368:Aged; D005260:Female; D005434:Flow Cytometry; D006801:Humans; D054990:Idiopathic Pulmonary Fibrosis / Q000378:metabolism*; D007249:Inflammation; D008168:Lung / Q000000981:diagnostic imaging; D008297:Male; D059630:Mesenchymal Stem Cells / Q000166:cytology; D008875:Middle Aged; D011446:Prospective Studies; D011877:Radionuclide Imaging; D012129:Respiratory Function Tests; D017154:Stromal Cells / Q000166:cytology*