Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis

Launched by JIANGSU TOPCEL-KH PHARMACEUTICAL CO., LTD. · May 31, 2024

Keywords

ClinConnect Summary

This clinical trial is looking into a new treatment option for chronic radiation proctitis, a condition that can occur after patients receive radiation therapy for pelvic cancers. The study is testing the safety and early effectiveness of injections made from mesenchymal stem cells derived from human umbilical cords. These stem cells are special cells that can help heal damaged tissue and may improve symptoms for people suffering from this condition.

To participate in the trial, you must be between 18 and 80 years old, in good health, and have been diagnosed with chronic radiation proctitis after radiation treatment for a pelvic tumor. You also need to have tried standard treatments without success. Participants will undergo an evaluation to ensure they meet all the necessary health criteria and will need to agree to certain precautions, such as using non-drug contraceptive methods during the trial. If you qualify and choose to join, you can expect close monitoring by the medical team to assess how well the treatment works and to keep track of your health and safety throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Fully understand and sign the informed consent form;
• • 2. Age ≥18 years and \<80 years;
• • 3. Good physical condition (WHO performance status score 0-1);
• • 4. Pathologically diagnosed with pelvic malignant tumors and received radiotherapy;
• • 5. Diagnosed with chronic radiation proctitis after at least 6 months of endoscopic examination following the completion of radiotherapy and ineffective conventional treatment;
• • 6. Screening period LENT-SOMA score ≥1;
• • 7. 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 Criteria:
• • 1. Patients with severe liver or kidney dysfunction during the screening period;
• • 2. Patients with severe congestive heart failure or coronary artery disease during the screening period;
• • 3. Patients with allergic constitution or severe systemic immune diseases;
• • 4. Patients with active gastrointestinal bleeding or acute intestinal obstruction during the screening period;
• • 5. Pregnant patients;
• • 6. Patients with rectal stenosis or fistula formation requiring surgical treatment that limits endoscopic therapy;
• • 7. Patients with a screening period LENT-SOMA score of 4;
• • 8. Patients with tumor recurrence or metastasis;
• • 9. 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;
• • 10. Other situations deemed unsuitable for inclusion in this study by the investigator.