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

NCT ID: NCT01977131

Last Updated: 2013-11-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Silicosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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stromal cells modified HGF

Group Type EXPERIMENTAL

Cells

Intervention Type OTHER

Interventions

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Cells

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wei Yu

OTHER

Sponsor Role lead

Responsible Party

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Wei Yu

Doctor

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type DERIVED
PMID: 26400297 (View on PubMed)

Other Identifiers

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2010B031600019

Identifier Type: -

Identifier Source: org_study_id