Injection of stem cells to treat chronic radiation proctitis

Safety and Preliminary Efficacy of Umbilical-Cord-Derived Mesenchymal Stem Cells Injection for Chronic Radiation Proctitis

This study is testing if injecting stem cells from umbilical cords can help people with chronic radiation proctitis feel better when other treatments haven't worked.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 1 site (Nanjing, Jiangsu)
• Trial ID: NCT06438809 on ClinicalTrials.gov

What this trial studies

This Phase I/II study evaluates the safety and preliminary efficacy of injecting human umbilical cord-derived mesenchymal stem cells (MSCs) to treat chronic radiation proctitis, a condition that can arise after pelvic radiation therapy. The study aims to address the complications caused by radiation damage to the rectum, which can lead to symptoms such as rectal bleeding and pain. By utilizing MSCs, known for their anti-inflammatory and tissue repair properties, the study seeks to provide a novel therapeutic option for patients who have not responded to conventional treatments. Participants will be monitored for safety and effectiveness over the course of the trial.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with a history of pelvic malignancies who have developed chronic radiation proctitis after radiotherapy.

Not a fit: Patients with severe liver or kidney dysfunction, or those with significant cardiovascular issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce symptoms and improve the quality of life for patients suffering from chronic radiation proctitis.

How similar studies have performed: Previous studies have shown promising results with MSC treatments for radiation proctitis, indicating potential for success in this approach.

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.

Where this trial is running

Nanjing, Jiangsu

• Jinling Hospital — Nanjing, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Zhaoshen Li, MD

Conditions Chronic Radiation Proctitis