Status:
COMPLETED
Safety of Stem Cells Intrabronchial Instillation for Silicosis
Lead Sponsor:
Universidade Federal do Rio de Janeiro
Collaborating Sponsors:
Ministry of Science and Technology, Brazil
Ministry of Health, Brazil
Conditions:
Chronic and Accelerated Silicosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief 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 cel...
Detailed Description
This study will perfume the safety (Phase I) study of 10 patients with silicosis treated with intrabronchial instillation of autologous bone marrow derived mononuclear cells (BMDMC, 2x107) through bro...
Eligibility Criteria
Inclusion
- 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
- smoking, active tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or cardiac diseases, and pregnancy
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01239862
Start Date
August 1 2009
End Date
December 1 2013
Last Update
May 27 2015
Active Locations (1)
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1
Hospital Universitário Clementino Fraga Filho - Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, Brazil, 21949900