Status:
NOT_YET_RECRUITING
Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis
Lead Sponsor:
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Conditions:
Radiation Proctitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
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
Inclusion
- 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.
- The LENT-SOMA score was ≥1 during the screening period.
- All subjects and their partners were not planning to have a child from screening to the end of the trial and agreed to use effective non-drug contraception during the trial.
Exclusion
- 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.
- Patients with rectal stenosis or fistula formation that restricts endoscopic treatment and require surgical treatment.
- Patients with a LENT-SOMA score of 4 during the screening period.
- Serum virology test (HBeAg, HCV antibody, HlV antibody, Treponema pallidum antibody) positive.
- Patients with uncontrolled tumors, tumor recurrence or metastasis.
- Subjects received any investigational drug within 3 months prior to the screening.
- Subjects received stem cell treatment.
- Participants considered inappropriate to participate in this clinical trial
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06925607
Start Date
April 1 2025
End Date
December 1 2026
Last Update
April 13 2025
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.