Abstract
Introduction: Preclinical data in rodent models of lung diseases, including COPD and pulmonary fibrosis, as well as recent data from a few small, early phase clinical trials in patients suggest safety and feasibility of both systemic and direct airway mesenchymal stem cell (MSC) administration.
Aim: We, therefore, hypothesized that autologous endobronchial or intravenous infusion of adipose derived mesenchymal stem cells (ADMSCs) is safe and well tolerated as a therapeutic modality in COPD or Combined Pulmonary Fibrosis- Emphysema (CPFE) patients.
Methods: After informed consent, we treated 8 COPD and 5 CPFE patients with moderate disease, 10 male, 3 female, all smokers, age 44-75 yrs. Autologous ADMSCs were harvested by lipoaspiration, and after isolation, activation and laser photostimulation, a mean 160.106 (range 182-300.106) cells isolated and given in 3 infusions IV or endobronchialy.
Results: There were no infusion toxicities or serious adverse events related to MSCs administration were observed in a follow up period up to 12 months. No significant mean change in pulmonary function tests (FVC, FEV1, TLC, TLco) tests was observed.
Conclusions: The results (safety and feasibility) of this phase 1 open trial encourage proceeding to phase 2 testing of ADMSCs for moderate to severe COPD and CPFE patients with a primary focus on safety and secondary outcomes including respiratory, systemic, and biological endpoints.
- Copyright ©ERS 2015