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

Wei Yu

Status and phase: Completed; Phase 2; Phase 1

Conditions: Silicosis

Treatments: Other: Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT01977131

2010B031600019

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Single Blind

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10 participants in 1 patient group

stromal cells modified HGF

Experimental group

Treatment:

Other: Cells