CompletedPhase 1

Safety of Stem Cells Intrabronchial Instillation for Silicosis

Brazil5 participantsStarted 2009-08

Plain-language summary

The aim of this study was to analyze the safety, pulmonary function, and quality of life data of patients with silicosis treated with intrabronchial instillation of bone marrow derived mononuclear cells (BMDMC, 2x107) through bronchoscopy.

Who can participate

Age range18 Years – 50 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria:age between 18-50, chronic and accelerated silicosis, characterized with a fibrotic increase in the last two years, FEV1 \<60% and \> 40%, FVC \> 60% and SaO2 \>90% Exclusion Criteria: smoking, active tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or cardiac diseases, and pregnancy

What they're measuring

Absence of lung deficits during the procedure and/or in the 4 months follow-up

Timeframe: 4 months

Trial details

NCT IDNCT01239862

SponsorUniversidade Federal do Rio de Janeiro

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-05

View on ClinicalTrials.gov More Chronic and Accelerated Silicosis trials