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NCT01977131 Clinical Trial

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

Silicosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01977131
Other study ID # 2010B031600019
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received October 30, 2013
Last updated November 20, 2013
Start date June 2010
Est. completion date September 2013

Study information
Verified date November 2013
Source Guangzhou Municipal Twelfth People's Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ministry of Science and Technology
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date September 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Cells

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Wei Yu

Outcome
Type Measure Description Time frame Safety issue
Primary Absence of lung deficits during the procedure and/or in the 6 months follow-up 6 months Yes
Secondary Improvement of pulmonary deficits 1 year Yes
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