Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Southwest Hospital, China | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| treatment group | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clinical grade umbilical cord mesenchymal stem cells | Biological | 10^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after fully lavage of the localized lesions |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| JianWu Dai, Ph.D | Chinese Academy of Sciences | Principal Investigator |
| Wei Xiong, M.D | First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital) | Study Chair |
| Xiaotian Dai, M.M | First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of the Third Military University, PLA (Southwest Hospital) | Chongqing | Chongqing Municipality | 400038 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Immunological Indicator in serum 1: T lymphocyte counts in peripheral blood | Cellular immunological indicator: T lymphocyte counts in peripheral blood measured in serum | 3-6 months |
| Immunological Indicator in serum 2: response level of CD4+ T lymphocyte subsets (such as Th1 / Th2) | Cellular immunological indicator: response level of CD4+ T lymphocyte subsets (such as Th1 / Th2) measured in serum | 3-6 months |
| Immunological Indicator in serum 3: concent of immunoglobulin | Humoral immunological indicator: concent of immunoglobulin measured in serum | 3-6 months |
| Immunological Indicator in serum 4: expression levels of various cytokines (IL-1, IL-3, IL-6, IL-8, TNF-α, GM-CSF, etc) | Humoral immunological indicator: expression levels of various cytokines in serum (IL-1, IL-3, IL-6, IL-8, TNF-α, GM-CSF, etc) measured in serum | 3-6 months |
| Immunological Indicator in serum 5: subtype analysis and phagocytic activity analysis of macrophage | Macrophage-related polarization indicator: subtype analysis and phagocytic activity of macrophage measured in serum | 3-6 months |
| Immunological Indicator in serum 6: expression levels of IL-12, IL-10 | Macrophage- related polarization indicators: expression levels of IL-12, IL-10 measured in serum | 3-6 months |
| Immunological Indicator in lavage fluid 1: T lymphocyte counts in peripheral blood | Cellular immunological indicator: T lymphocyte counts in peripheral blood measured in lavage fluid | 6 months |
| Immunological Indicator in lavage fluid 2: response level of CD4+ T lymphocyte subsets (such as Th1 / Th2) | Cellular immunological indicator: response level of CD4+ T lymphocyte subsets (such as Th1 / Th2) measured in lavage fluid | 6 months |
| Immunological Indicator in lavage fluid 3: concent of immunoglobulin | Humoral immunological indicator: concent of immunoglobulin measured in lavage fluid | 6 months |
| Immunological Indicator in lavage fluid 4: expression levels of various cytokines (IL-1, IL-3, IL-6, IL-8, TNF-α, GM-CSF, etc) | Humoral immunological indicator: expression levels of various cytokines (IL-1, IL-3, IL-6, IL-8, TNF-α, GM-CSF, etc) measured in lavage fluid | 6 months |
| Immunological Indicator in lavage fluid 5: subtype analysis and phagocytic activity analysis of macrophage | Macrophage-related polarization indicator: subtype analysis and phagocytic activity of macrophage measured in lavage fluid | 6 months |
| Immunological Indicator in lavage fluid 6: expression levels of IL-12, IL-10 | Macrophage-related polarization indicators: expression levels of IL-12, IL-10 measured in lavage fluid | 6 months |
| Inflammatory Indicators: measured by routine blood test including C-reactive protein (CRP) | 3 months |
| Fibrosis Indicators in serum 1: content of transforming growth factor -α/β (TGF-α/TGF-β) | Content of transforming growth factor α/β (TGF-α/TGF-β) measured in serum | 3-6 months |
| Fibrosis Indicators in serum 2: content of hydroxyproline | Content of hydroxyproline measured in serum | 3-6 months |
| Fibrosis Indicators in serum 3: content of matrix metalloproteinase 1/7(MMP1/MMP7) | Content of matrix metalloproteinase 1/7(MMP1/MMP7) measured in serum | 3-6 months |
| Fibrosis Indicators in lavage fluid 1: content of transforming growth factor -α/β (TGF-α/TGF-β) | Content of transforming growth factor -α/β (TGF-α/TGF-β) measured in lavage fluid | 6 months |
| Fibrosis Indicators in lavage fluid 2: content of hydroxyproline | Content of hydroxyproline measured in lavage fluid measured in lavage fluid | 6 months |
| Fibrosis Indicators in lavage fluid 3: content of matrix metalloproteinase 1/7(MMP1/MMP7) | Content of matrix metalloproteinase 1/7(MMP1/MMP7) measured in lavage fluid | 6 months |