Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorJiangsu Topcel-KH Pharmaceutical Co., Ltd.

About this trial

A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis

Eligibility criteria

Qualifiers

Signed informed consent

Good physical condition (WHO performance status score 0-1).

Patient received radiotherapy after being pathologically diagnosed with pelvic malignant tumors

Patient diagnosed with chronic radiation proctitis after undergoing colonoscopy more than 6 months after the completion of radiotherapy and did not respond to conventional treatment.

Disqualifiers

Patients with severe, progressive and uncontrollable diseases of the liver, blood, gastrointestinal tract, endocrine system, lungs, heart, nervous system, mental system or brain.

Patients with allergic constitution or severe systemic autoimmune diseases.

Patients with active massive gastrointestinal bleeding or acute intestinal obstruction during the screening period.

Pregnant or lactating women.

Trial design

Treatments tested in this trial

  • Mesenchymal Stem Cells (MSCs)

Treatment groups

6 Participants
are divided into 1 treatment group

Locations

This trial has no locations