A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
6
single 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
Time frame: 8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour
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.
Time frame: Week1, Week 4, Week 24,Month 24
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.
Time frame: Week 4,Week 24
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.
Time frame: Week 1
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