Phase I Study of Radiation-induced Pulmonary Fibrosis Treated With Clinical Grade Umbilical Cord Mesenchymal Stem Cells
Sponsor study identifier
interventional
10
1 country
1
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2018
Actual (reported)Study Completion
December 2018
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
October 20, 2014
Actual (reported)October 28, 2014
Actual (reported)December 2018
Actual (reported)December 2018
Actual (reported)Composite indicators, including quantitative analysis of CT density histograms, self-evaluation and changes of TGF-β1 content
Different proportions will be assigned to the three indicators. The overall curative effect can be judged with scores ranging from 0 to100. Specific proportions are as follows: full scores of 50 points for image changes, 25 for self-efficacy evaluation and 25 for TGF-β1 content changes. The image changes can be classified into four levels: significant control, improved, stable, and progressive; the self-efficacy evaluation can also be classified into four levels: effective, improved, stable and invalid; the changes of TGF-β1 content will be classified into three levels: improved, stable, and progressive. The four levels will be scored on the ratio of 5:4:3:1, the three levels will be scored on the ratio of 5:3:1.
6 months
Safety Evaluation
Clinical adverse events evaluated as definitely/ probably/possibly concerned with stem cell therapy in this trial and abnormal results of laboratory tests or other special examinations will be observed and recorded in detail.
6 months
Clinical Indicator 1: change in blood gas analysis
3-6 months
Clinical Indicator 2: change in pulmonary function analysis
3-6 months
Clinical Indicator 3: 6-minute walk test distance
3-6 months
Clinical Indicator 4: change in MRC chronic dyspnea scale
3-6 months
Clinical Indicator 5: change in St. George's Respiratory Questionnaire (SGRQ) scale
3-6 months
Patients will receive 10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord mesenchymal stem cells (MSCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions
10\^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after fully lavage of the localized lesions
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital)
Chongqing, Chongqing Municipality, 400038, China
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)
10 participants (actual enrollment reported by the registry).
First Submitted
October 20, 2014
First Posted
October 28, 2014
Study Start
October 2014
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
December 2018
Actual (reported)Study Completion
December 2018
Actual (reported)Last Updated
July 24, 2019
Record last verified: 2018-07
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: