Pilot safety study of intrabronchial instillation of bone marrow-derived mononuclear cells in patients with silicosis

BMC Pulmonary Medicine

José R. Lapa e Silva⁴  Lea M. B. Fonseca²  Patricia R. M. Rocco⁵  Regina C. Goldenberg³  Alexandre P. Cardoso⁴  Alberto J. Araújo⁴  Miquéias Lopes-Pacheco⁵  Bianca Gutfilen²  Taís H. K. Brunswick³  Leandro Vairo³  Amir Szklo⁴  Marina A. Lima⁴  Luiz Paulo Loivos⁴  Sérgio A. L. Souza²  Marcelo M. Morales¹ 

[1] Laboratory of Cellular and Molecular Physiology, Institute of Biophysics Carlos Chagas Filho, da Saude Science Center, Federal University of Rio de Janeiro, Ilha do Fundão, Rio de Janeiro, 21941-902, RJ, Brazil;Nuclear Medicine Service, Clementino Fraga Filho University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil;Laboratory of Cellular and Molecular Cardiology, Institute of Biophysics Carlos Chagas Filho, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil;Institute of Thoracic Medicine, Clementino Fraga Filho University Hospital, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil;Laboratory of Pulmonary Investigation, Institute of Biophysics Carlos Chagas Filho, Federal University of Rio de Janeiro, Rio de Janeiro, Brazil

关键词: Cell therapy;    Lung fibrosis;    Chronic inflammation;    Pneumoconiosis;   

Others  :  1216162
DOI  :  10.1186/s12890-015-0061-8

 received in 2015-03-13, accepted in 2015-05-28,  发布年份 2015

【 摘 要 】

Background

Silicosis is an occupational disease for which no effective treatment is currently known. Systemic administration of bone marrow-derived mononuclear cells (BMDMCs) has shown to be safe in lung diseases. However, so far, no studies have analyzed whether bronchoscopic instillation of autologous BMDMCs is a safe route of administration in patients with silicosis.

Methods

We conducted a prospective, non-randomized, single-center longitudinal study in five patients. Inclusion criteria were age 18–50 years, chronic and accelerated silicosis, forced expiratory volume in 1 s <60 % and >40 %, forced vital capacity ≥60 % and arterial oxygen saturation >90 %. The exclusion criteria were smoking, active tuberculosis, neoplasms, autoimmune disorders, heart, liver or renal diseases, or inability to undergo bronchoscopy. BMDMCs were administered through bronchoscopy (2 × 10⁷ cells) into both lungs. Physical examination, laboratory evaluations, quality of life questionnaires, computed tomography of the chest, lung function tests, and perfusion scans were performed before the start of treatment and up to 360 days after BMDMC therapy. Additionally, whole-body and planar scans were evaluated 2 and 24 h after instillation.

Results

No adverse events were observed during and after BMDMC administration. Lung function, quality of life and radiologic features remained stable throughout follow-up. Furthermore, an early increase of perfusion in the base of both lungs was observed and sustained after BMDMC administration.

Conclusion

Administration of BMDMCs through bronchoscopy appears to be feasible and safe in accelerated and chronic silicosis. This pilot study provides a basis for prospective randomized trials to assess the efficacy of this treatment approach.

Clinical trials.gov identifier

NCT01239862 webcite Date of Registration: November 10, 2010

【 授权许可】

   
2015 Morales et al.; licensee BioMed Central.

【 图 表 】

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