A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis
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.
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.
Single group
Mesenchymal Stem Cells (MSCs)
Drugsingle dose injection (120 million cells)
Radioactive distribution
The radioactive distribution in the injection site and various organs or tissues after local injection in patients with radiation proctitis
Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events
All subjects were observed for any adverse events/reactions or serious adverse events/reactions that occurred during the clinical trial, including but not limited to clinically significant abnormal changes in clinical symptoms, physical examination, vital signs examination, laboratory examination, 12- ead electrocardiogram examination, etc. The clinical features, severity, occurrence time, end time, treatment and outcome of the disease should be recorded, and the correlation between the disease and the investigational drug should be determined.
Effectiveness endpoint:Clinical symptom assessment, endoscopic evaluation and clinical improvement.
The clinical symptom assessment adopts the LENT-SOMA score， total score ranges from 0 to 4, higher score means more severe symptoms. The endoscopic evaluation adopts the Vienna Rectoscopy Score, The score range from 0 to 5 points. The highest score of each individual item is counted as the total VRS score. Higher the VRS score means more severe lesions.
Radiation exposure
The uptake rate (%ID), absorbed dose and whole-body effective dose of important organs or tissues after local injection administration of \[89Zr\] human-derived TH-SC01 cell injection.
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