A Phase I/II study to evaluate the safety and preliminary efficacy of human umbilical cord-derived mesenchymal stem cell injection for the treatment of chronic radiation proctitis.
Fully understand and sign the informed consent form;
Age ≥18 years and <80 years;
Good physical condition (WHO performance status score 0-1);
Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;
Patients with severe liver or kidney dysfunction during the screening period;
Patients with severe congestive heart failure or coronary artery disease during the screening period;
Patients with allergic constitution or severe systemic immune diseases;
Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;
Single group
Mesenchymal Stem Cells (MSCs)
Biological/VaccineMSC suspension single does injection.
The severity of adverse events after administration as assessed by CTCAE v5.0.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe.
The incidence of adverse events after administration.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention.
The severity of adverse events after administration as assessed by CTCAE v5.0.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention. Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 is a grading scale which can be utilized for adverse event (AE) reporting. It ranges from grade 1 (mild) to grade 5 (death related to AE) , and higher grade means the AE is more severe.
The incidence of adverse events after administration.
Adverse events are any unexpected medical occurrences in a participant that may not be directly caused by the trial intervention.
The recurrence of chronic radiation proctitis symptoms after administration.
The recurrence means that subjects who were previously cured or relieved are diagnosed again by the investigator, clinically, as having chronic radiation proctitis.
The deterioration of chronic radiation proctitis symptoms after administration.
The deterioration means that the symptoms of chronic radiation proctitis have worsened compared to baseline.
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