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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-79
SponsorJiangsu Topcel-KH Pharmaceutical Co., Ltd.

About this trial

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 criteria

Qualifiers

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;

Disqualifiers

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;

Trial design

Treatments tested in this trial

  • Mesenchymal Stem Cells (MSCs)

Treatment groups

24 Participants
are divided into 1 treatment group