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

Phase 1

Completed

• Conditions: Silicosis
• Interventions: Other: Cells

• Registration Number: NCT01977131
• Lead Sponsor: Wei Yu

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Primary Completion: 2013-06
• Study Completion: 2013-09
• Study First Submitted: 2013-10-30
• Study First Submitted QC: 2013-10-30
• Status Verified: 2013-11
• Study First Posted: 2013-11-06
• Last Update Submitted: 2013-11-20
• Last Update Posted: 2013-11-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
stromal cells modified HGF	Cells	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Improvement of pulmonary deficits	1 year