Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis

The aim of this study was to analyze the safety, pulmonary function, and imaging changes of patients with silicosis treated with autologous bone marrow stromal cells with modification by hepatocyte growth factor.

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Key information

Conditions

Silicosis Lung Diseases Lung Diseases, Interstitial Lung Injury Occupational Diseases Pneumoconiosis Respiratory Tract Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cells

Other

Primary outcomes

Absence of lung deficits during the procedure and/or in the 6 months follow-up

Time frame: 6 months

Secondary outcomes

Improvement of pulmonary deficits

Time frame: 1 year

Sponsors and collaborators

Lead sponsor

Wei Yu

Other

Registry information

Official study title

Phase 1 Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis

Important dates

Study start: 2010
Primary completion: 2013
Study completion: 2013
First posted: Nov 6, 2013
Registry last updated: Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed