Combined Bone Marrow-Derived Mesenchymal Stromal Cell Therapy and One-Way Endobronchial Valve Placement in Patients with Pulmonary Emphysema: A Phase I Clinical Trial
Autor: | Hugo Goulart de Oliveira, Amarilio Vieira de Macedo Neto, Fábio Munhoz Svartman, Marcelo M. Morales, Tamara Borgonovo, Carmen Lúcia Kuniyoshi Rebelatto, Fernanda F. Cruz, Patricia R. M. Rocco, José Roberto Lapa e Silva, Paulo Roberto Slud Brofman, Mariana A. Antunes, Guilherme A. P. de Oliveira, Daniel J. Weiss |
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Rok vydání: | 2016 |
Předmět: |
Adult
Male 0301 basic medicine Spirometry medicine.medical_specialty Mesenchymal stromal cells Endobronchial valves Mesenchymal Stem Cell Transplantation Air trapping Gastroenterology 03 medical and health sciences 0302 clinical medicine Translational Research Articles and Reviews Tissue Engineering and Regenerative Medicine Lung volume reduction Internal medicine Concomitant Therapy medicine Humans Adverse effect Aged Aged 80 and over Pulmonary Valve COPD medicine.diagnostic_test business.industry Chronic obstructive pulmonary disease Endobronchial valve Mesenchymal Stem Cells Cell Biology General Medicine Middle Aged Airway obstruction medicine.disease Respiratory Function Tests Surgery C-Reactive Protein Treatment Outcome 030104 developmental biology medicine.anatomical_structure Pulmonary Emphysema 030228 respiratory system Quality of Life Female Bone marrow medicine.symptom business Developmental Biology |
Zdroj: | Stem Cells Translational Medicine |
ISSN: | 2157-6580 2157-6564 |
Popis: | One-way endobronchial valves (EBV) insertion to reduce pulmonary air trapping has been used as therapy for chronic obstructive pulmonary disease (COPD) patients. However, local inflammation may result and can contribute to worsening of clinical status in these patients. We hypothesized that combined EBV insertion and intrabronchial administration of mesenchymal stromal cells (MSCs) would decrease the inflammatory process, thus mitigating EBV complications in severe COPD patients. This initial study sought to investigate the safety of this approach. For this purpose, a phase I, prospective, patient-blinded, randomized, placebo-controlled design was used. Heterogeneous advanced emphysema (Global Initiative for Chronic Lung Disease [GOLD] III or IV) patients randomly received either allogeneic bone marrow-derived MSCs (108 cells, EBV+MSC) or 0.9% saline solution (EBV) (n = 5 per group), bronchoscopically, just before insertion of one-way EBVs. Patients were evaluated 1, 7, 30, and 90 days after therapy. All patients completed the study protocol and 90-day follow-up. MSC delivery did not result in acute administration-related toxicity, serious adverse events, or death. No significant between-group differences were observed in overall number of adverse events, frequency of COPD exacerbations, or worsening of disease. Additionally, there were no significant differences in blood tests, lung function, or radiological outcomes. However, quality-of-life indicators were higher in EBV + MSC compared with EBV. EBV + MSC patients presented decreased levels of circulating C-reactive protein at 30 and 90 days, as well as BODE (Body mass index, airway Obstruction, Dyspnea, and Exercise index) and MMRC (Modified Medical Research Council) scores. Thus, combined use of EBV and MSCs appears to be safe in patients with severe COPD, providing a basis for subsequent investigations using MSCs as concomitant therapy. |
Databáze: | OpenAIRE |
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