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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01977131

Enrollment

Registered

2013-11-06

Start date

2010-06-30

Completion date

2013-09-30

Last updated

2013-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Silicosis

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.

Interventions

OTHERCells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
Improvement of pulmonary deficits	1 year

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026