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    The value 'Show more Show more Revision: v2.9.0' has been updated to 'Show less Genetic and Rare Diseases Information Center resources: Chronic Graft Versus Host Disease FDA Drug and Device Resources Show less Design Details Primary Purpose : Treatment Allocation : N/A Interventional Model : Single Group Assignment Masking : None (Open Label) Arms and Interventions Participant Group/Arm Intervention/Treatment Experimental : Bronchial basal cells Biological : bronchial basal cells Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy. Primary Outcome Measures Outcome Measure Measure Description Time Frame Forced expiratory volume in one second (FEV1) One of the indicators in pulmonary function test, a marker to assess airway obstruction 1-6 months Diffusion capacity of CO (DLCO) One of the indicators in pulmonary function test, the extent to which oxygen passes from the air sacs of the lungs into the blood 1-6 months Secondary Outcome Measures Outcome Measure Measure Description Time Frame The ratio of forced expiratory volume in the first one second to the forced vital capacity (FEV1/FVC) One of the indicators in pulmonary function test, representing the proportion of a person's vital capacity that they are able to expire in the first second of forced expiration to the full vital capacity 1-6 months Maximum mid-expiratory flow (MMF) One of the indicators in pulmonary function test, standing for maximal (mid-)expiratory flow and is the peak of expiratory flow as taken from the flow-volume curve and measured in liters per second 1-6 months Maximum voluntary ventilation (MVV) One of the indicators in pulmonary function test, measuring the maximum amount of air that can be inhaled and exhaled within one minute 1-6 months Forced vital capacity (FVC) One of the indicators in pulmonary function test, indicating the maximum amount of air a person can expel from the lungs after a maximum inhalation 1-6 months 6-minute-walk test (6MWT) An indicator to evaluate the exercise function of patients with moderate or severe pulmonary heart diseases 1-6 months Modified medical research council (MMRC) chronic dyspnea scale An indicator to evaluate the level of dyspnea 1-6 months St. George's respiratory questionnaire (SGRQ) scale A questionnaire to assess life quality affected by the respiratory problems 1-6 months Imaging of lung by high resolution computed tomography (HR-CT) HR-CT images of lung will be analyzed to indicate the pulmonary structure. 1-6 months Additional Relevant MeSH Terms Respiratory Tract Diseases Respiration Disorders Plan to Share Individual Participant Data (IPD)? No Studies a U.S. FDA-Regulated Drug Product No Studies a U.S. FDA-Regulated Device Product No Helpful Links Provided by Regend Therapeutics Related Info Revision: v2.9.1'. This change represents an update in the study details and revision information.
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    Check dated 2024-06-25T08:57:58.000Z thumbnail image

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