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

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 79
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Jinling Hospital
RECRUITING
Nanjing
Contact Information
Primary
Zhaoshen Li, MD
zhsl@vip.163.com
021-81873241
Time Frame
Start Date: 2024-05-24
Estimated Completion Date: 2025-05
Participants
Target number of participants: 24
Treatments
Experimental: Open label single arm study
All patients will receive a single injection of umbilical cord-derived mesenchymal stem cells (120 million cells), and their therapeutic response will be monitored over a period of 24 months.
Related Therapeutic Areas
Sponsors
Leads: Jiangsu Topcel-KH Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov