RecruitingPhase 1Phase 2NCT06438809
Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis
Sponsor
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Enrollment
24 participants
Start Date
May 24, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 79 Years
Inclusion Criteria7
- 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 endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;
- Screening period LENT-SOMA score ≥1;
- Subjects and their spouses or partners have no plans for conception from screening to 6 months after the end of the trial, no plans for sperm or egg donation, and agree to use effective non-pharmacological contraceptive measures during the trial.
Exclusion Criteria10
- 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;
- Pregnant patients;
- Patients with rectal stenosis or fistula formation requiring surgical treatment that limits 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 screening or 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.
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Interventions
BIOLOGICALMesenchymal Stem Cells (MSCs)
MSC suspension single does injection.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06438809