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This study aims to evaluate the safety and efficacy of the umbilical cord blood mononuclear cells (UCB-MNCs) therapy for radiation-induced lung injuryr (RILI) by observing factors related to the therapeutic effect and adverse reactions of UCB-MNCs in treating RILI .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCB-MNCs | Experimental | UCB-MNCs are obtained from umbilical cord blood by density gradient centrifugation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCB-MNCs | Biological | UCB-MNCs were administered via intravenous infusion three times, once per week, with a dose of 3×10⁸ cells per infusion. |
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| Measure | Description | Time Frame |
|---|---|---|
| Chest Enhanced CT Scan report | Evaluate changes in lung damage ，and calculate the change in total lesion volume as a percentage of total lung volume. | Baseline and at 1、3、6 and 12 months after the last treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Medical Research Council Dyspnea Scale (mMRC Score) | mMRC Score is a subjective scale for assessing the severity of breathing difficulties,dyspnea is classified into five grades (0 to 4). The higher the grade, the more severe the symptoms and the more obvious the limitation of movement. | Baseline and at 1、3 、6 and 12 months after the last treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ji ZHU | Contact | 0571-88128212 | zhuji@zjcc.org.cn |
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| 6-minute walking distance test（6MWT） | The 6-minute walking distance (6MWD) is a method for assessing a patient's cardiopulmonary function and exercise endurance by measuring the maximum distance they can walk as fast as possible within 6 minutes. | Baseline and at 1、3 、6 and 12 months after the last treatment. |
| Change from baseline in forced expiratory volume in 1st second (FEV1) | FEV1 is the maximal volume of air that can be expired in 1st second of forced vital capacity maneuver using spirometry. We measured FEV1 at baseline and at 1、3 、6 months and 12 months after the last treatment. | We measured FEV1 at baseline and at 1、3 、6 months and 12 months after the last treatment. |
| Change from baseline in forced vital capacity (FVC) | Forced vital capacity (FVC) is the maximal volume of air that can be expired while patient performs forced expiration as fast and as deep as possible using spirometry. We measured FEV1 at baseline and at 1、3 、6 months and 12 months after the last treatment. | We measured FVC at baseline and at 1、3 、6 months and 12 months after the last treatment. |
| Change from baseline in FEV1/FVC ratio | FEV1/FVC is used to differentiate obstructive from restrictive patterns by spirometry. We measuredFEV1/ FVC at baseline and at 1、3 、6 months and 12 months after the last treatment. | We measuredFEV1/ FVC at baseline and at 1、3 、6 months and 12 months after the last treatment. |
| Change from baseline in lung Carbon Monoxide Diffusion Capacity (DLCO) | DLCO will be measured using the single breath-hold method with a Quark PFT gas analyzer, following ATS/ERS standards. Each test involves inhalation of a gas mixture (0.3% CO, 0.3% CH4, and dry air), breath-holding for 10±2 seconds, and exhalation. We measured DLCO at baseline and at 1、3 、6 months and 12 months after the last treatment. | We measured DLCO at baseline and at 1、3 、6 months and 12 months after the last treatment. |
| Arterial blood gas parameter like pH value | Compare pH value at baseline and at 1、3 、6 months and 12 months after the last treatment. | We measured pH value at baseline and at 1、3 、6 months and 12 months after the last treatment. |
| Arterial blood gas parameter like partial pressure of oxygen (PO2) | Compare the partial pressure of oxygen (PO2) at baseline and at 1、3 、6 months and 12 months after the last treatment. | We measured PO2 at baseline and at 1、3 、6 months and 12 months after the last treatment. |
| Arterial blood gas parameter like oxygen saturation (SO2) | Compare the oxygen saturation (SO2) at baseline and at 1、3 、6 months and 12 months after the last treatment. | We measured SO2 at baseline and at 1、3 、6 months and 12 months after the last treatment. |
| Arterial blood gas parameter like partial pressure of carbon dioxide (PCO2) | Compare the partial pressure of carbon dioxide (PCO2) at baseline and at 1、3 、6 months and 12 months after the last treatment. | We measured PCO2 at baseline and at 1、3 、6 months and 12 months after the last treatment. |