The purpose of this study is to evaluate the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
A Phase I clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with perianal fistula
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
single dose injection (120 million cells)
The first Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGStandardized uptake value
Standardized values of organs or tissues after PET/CT imaging after local injection in patients with perianal fistula
Time frame: 8-12 hour、32-36 hour、56-60 hour、104-108 hour、152-156 hour,296-300 hour
Effectiveness endpoint:Proportion of subjects with clinically significant effect at week 24 after local injection
Change from baseline in pain score (VAS score).Total score ranges from 0 to 10. Higher score means more pain.
Time frame: Week 1,Week 4,Week 24
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-lead 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: Week 1,Week 4,Week 24,Month 24
Radiation exposure: Uptake rate (%ID), absorbed dose, and systemic effective dose in vital organs or tissues after local injection of nuclide labeled TH-SC01 cells.
Based on the image data obtained by PET/CT scan, OLINDA's sphere model was used to delineate the injection site and important organs or tissues as areas of interest (ROI), obtain standardized uptake values (SUV) of each ROI, and obtain time-radioactive activity curves (TACs) of each tissue and organ. The absorbed dose of vital organs or tissues, the equivalent dose of the whole body, and the distribution and change of transplanted cells in different tissues or organs at different time points are described
Time frame: Week 1
Miu Li Yan The First Affiliated Hospital of Soochow University
CONTACT
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.