Main purpose -To explore the safety and tolerance of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF). Secondary purpose * To explore the preliminary efficacy of human umbilical cord mesenchymal stem cells in the treatment of idiopathic pulmonary fibrosis (IPF), and to recommend the appropriate dose of cell therapy for subsequent clinical studies. * To explore the immunogenicity of human umbilical cord mesenchymal stem cell injection in the treatment of idiopathic pulmonary fibrosis (IPF). This study adopts a clinical research design of multi center, single dose and increasing dose. 18 qualified IPF subjects will be included in this study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Different doses of human umbilical cord mesenchymal stem cell injection were infused to the focus of patients with idiopathic pulmonary fibrosis through bronchoscope, and the tolerance of subjects to different doses of human umbilical cord mesenchymal stem cell injection was observed, and the curative effect was preliminarily observed.
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Tolerance of patients with idiopathic fibrosis to human umbilical cord mesenchymal stem cell injection
Incidence and severity of adverse events according to CTCAE5.0
Time frame: From the first administration to 4 weeks after administration
Dose exploration of patients with idiopathic fibrosis to human umbilical cord mesenchymal stem cell injection
The maximum tolerable dose (MTD) of a single administration depends on whether dose limiting toxicity (DLT) occurs within 4 weeks after the first administration, for example (1) Hematological toxicity of grade 3 and above caused by the treatment of human umbilical cord mesenchymal stem cell injection, (2) There are grade 3 and above non hematological toxic reactions caused by the treatment of human umbilical cord mesenchymal stem cell injection, except for the following cases, (3) Any other toxicity related to cell therapy that is higher than the baseline level is judged as clinically significant and / or unacceptable by the investigator and the sponsor, (4) There are acute exacerbations and serious adverse events (SAE) of IPF related to the treatment of human umbilical cord mesenchymal stem cell injection (which may be related, likely to be related and definitely related)
Time frame: From the first administration to 4 weeks after administration
Preliminary efficacy evaluation
Changes from baseline in St. George's respiratory questionnaire SGRQ, dyspnea score, cough score and 6-minute walk test (grade and distance)in the treatment of idiopathic pulmonary fibrosis (IPF), and to recommend the appropriate dose of cell therapy for subsequent clinical studies
Time frame: The 4th, 12th, 24th and 48th week after administration
Preliminary efficacy evaluation
Changes in lung function (FVC, DLCO sb) compared with baseline
Time frame: The 4th, 12th, 24th and 48th week after administration
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