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A Study on Radiation-induced Pulmonary Fibrosis Treated With Clinical Grade Umbilical Cord Mesenchymal Stem Cells

NCT02277145 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-07-24

No results posted yet for this study

Summary

Radiation therapy is one of the main means for treating malignant tumor, during which radioactive lung injury is inevitable. Currently there is nearly no effective clinical treatment for late post-radiotherapy pulmonary fibrosis. This study intends to carry out an open, single-center, non-randomized phase I clinical trial. During the treatment, the local lesions will be fully lavaged, and then clinical grade umbilical cord mesenchymal stem cells (MSCs) will be injected directly into the lesion by fiberoptic bronchoscopy. After six-month observation, the investigators will initially evaluate the safety and effectiveness of the treatment by measuring two key indicators-the CT density histogram and the patients' self-evaluation, and one secondary indicator-the changes of TGF-β1 contents, both before and after the treatment. Meanwhile, the investigators will make a preliminary discuss about the possible immunomodulatory effects of the umbilical cord MSCs.

Conditions

  • Post-radiotherapy Pulmonary Fibrosis

Interventions

BIOLOGICAL

clinical grade umbilical cord mesenchymal stem cells

10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after fully lavage of the localized lesions

Sponsors & Collaborators

  • Southwest Hospital, China

    collaborator OTHER

  • Jianwu Dai

    lead OTHER_GOV

Principal Investigators

  • JianWu Dai, Ph.D · Chinese Academy of Sciences

  • Wei Xiong, M.D · First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

  • Xiaotian Dai, M.M · First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-12-31
Completion
2018-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02277145 on ClinicalTrials.gov