Back to resultsSafety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis
Primary Purpose
Silicosis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Cells
Sponsored by
About this trial
This is an interventional treatment trial for Silicosis
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
stromal cells modified HGF
Arm Description
Outcomes
Primary Outcome Measures
Absence of lung deficits during the procedure and/or in the 6 months follow-up
Secondary Outcome Measures
Improvement of pulmonary deficits
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01977131
Brief Title
Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis
Official Title
Phase 1 Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Wei Yu
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Silicosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
stromal cells modified HGF
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Cells
Primary Outcome Measure Information:
Title
Absence of lung deficits during the procedure and/or in the 6 months follow-up
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Improvement of pulmonary deficits
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
26400297
Citation
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.
Results Reference
derived
Learn more about this trial
Safety Study of Autologous Bone Marrow Stromal Cells With Modification by Hepatocyte Growth Factor to Treat Silicosis
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