NCT06438809

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Jiangsu Topcel-KH Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Radiation therapy is frequently used to treat pelvic cancers such as anal, cervical, prostate, and rectal cancer. While effective in controlling local tumors, it can also cause collateral damage to the gastrointestinal tract. The rectum is particularly vulnerable to radiation damage due to its fixed position in the pelvis. In the acute phase, radiation can lead to proctitis, an inflammatory condition characterized by mucosal ulceration, edema, and loss of microvilli. Patients typically present within three months of radiation therapy with symptoms like diarrhea, urgency, and tenesmus. Chronic radiation proctitis can either follow the acute phase or appear after a symptom-free period, typically 8 to 12 months post-radiation treatment. This chronic condition results from radiation-induced small-vessel injury, causing ischemia, obliterative endarteritis, fibrosis, and neovascularization. Rectal bleeding is a common symptom of chronic radiation proctitis. Clinical studies have demonstrated that mesenchymal stem cell (MSC) treatment offers significant benefits, including anti-inflammatory, immune modulation, and tissue repair effects. Recent research indicates that intralesional injection of MSC is effective in treating radiation proctitis, reducing pain and bleeding without causing severe adverse events. This suggests that MSC treatment could be a promising option for radiation proctitis. This is a phase I/II study designed to evaluate the safety and preliminary efficacy of MSC treatment for radiation proctitis. Patients will be followed up for 24 months after treatment.

Conditions

• Chronic Radiation Proctitis

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal Stem Cells (MSCs)	MSC suspension single does injection.

Timeline

• Start date: 2024-05-24
• Primary completion: 2025-05-01
• Completion: 2025-05-01
• First posted: 2024-06-03
• Last updated: 2024-06-21

Locations

1 site across 1 country: China