Phase
Condition
Ulcerative Colitis (Pediatric)
Hemorrhoids
Rectal Disorders
Treatment
Mesenchymal Stem Cells (MSCs)
Clinical Study ID
Ages 18-79 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
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;
Diagnosed with chronic radiation proctitis after at least 6 months of endoscopicexamination following the completion of radiotherapy and ineffective conventionaltreatment;
Screening period LENT-SOMA score ≥1;
Subjects and their spouses or partners have no plans for conception from screeningto 6 months after the end of the trial, no plans for sperm or egg donation, andagree to use effective non-pharmacological contraceptive measures during the trial.
Exclusion
Exclusion Criteria:
Patients with severe liver or kidney dysfunction during the screening period;
Patients with severe congestive heart failure or coronary artery disease during thescreening period;
Patients with allergic constitution or severe systemic immune diseases;
Patients with active gastrointestinal bleeding or acute intestinal obstructionduring the screening period;
Pregnant patients;
Patients with rectal stenosis or fistula formation requiring surgical treatment thatlimits endoscopic therapy;
Patients with a screening period LENT-SOMA score of 4;
Patients with tumor recurrence or metastasis;
Patients currently participating in other clinical trials at the time of screeningor who have not been out of another clinical trial for less than 1 month;
Other situations deemed unsuitable for inclusion in this study by the investigator.
Study Design
Study Description
Connect with a study center
Jinling Hospital
Nanjing, Jiangsu 210016
ChinaActive - Recruiting
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