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CompletedNCT01977131Updated Nov 25, 2013

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

A Phase 1/2 interventional study of Cells in Silicosis, sponsored by Wei Yu. Completed. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2013-11-25.

Sponsored by Wei Yu · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Silicosis

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03

In context

Silicosis

20 studies on the registry are indexed under Silicosis; 3 are open to participants now.

Browse Silicosis studies →

Lead sponsor

This is the only study on the registry with Wei Yu as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • age between 18-50, chronic and accelerated silicosis, characterized with a fibrotic increase in the last two years, \<60% and > 40%, FVC > 60% and SaO2 >90%

Exclusion criteria

Exclusion Criteria:

  • smoking, active tuberculosis or other infections, cancer, auto-immune disorders, hematological, hepatic or cardiac diseases, and pregnancy
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
Single (Participant)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    stromal cells modified HGF

    Other: Cells

Interventions

  • OtherCells
06

What researchers measure

Primary outcomes

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

    Time frame: 6 months

Secondary outcomes

  1. Improvement of pulmonary deficits

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Liu WW, Wang HX, Yu W, Bi XY, Chen JY, Chen LZ, Ding L, Han DM, Guo ZK, Lei YX. Treatment of silicosis with hepatocyte growth factor-modified autologous bone marrow stromal cells: a non-randomized study with follow-up. Genet Mol Res. 2015 Sep 9;14(3):10672-81. doi: 10.4238/2015.September.9.7. PubMed 26400297 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01977131
Lead sponsor
Wei Yu
Responsible party
Wei Yu (Doctor, Guangzhou Municipal Twelfth People's Hospital) — Sponsor-investigator
First posted
Nov 6, 2013
Start date
Jun 2010
Primary completion
Jun 2013
Completion
Sep 2013
Last update
Nov 25, 2013

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2013. You cannot join it, but the record below documents what was studied.

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