Not yet recruiting NCT06925607
Evaluate the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mesenchymal Stem Cells (MSCs).
- Who it may be relevant to
- Registry conditions: Radiation Proctitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase l Clinical Study Evaluating the Distribution and Dynamic Behavior of Nuclide Labeled TH-SC01 Cells in Vivo in Patients With Radiation Proctitis
Overview
A Phase l clinical study evaluating the distribution and dynamic behavior of Nuclide labeled TH-SC01 cells in vivo in patients with Radiation proctitis
Interventions
- Drug Mesenchymal Stem Cells (MSCs)
single dose injection (120 million cells)
Primary outcome measures
- Radioactive distribution [Time frame: 8-12 hour、32-36 hour、 56-60 hour. 104-108 hour、152-156 hour, 296-300 hour]
Secondary outcome measures (3)
- Safety endpoint: Treatment-related adverse events/adverse reactions, serious adverse events/serious adverse events [Time frame: Week1, Week 4, Week 24，Month 24]
- Effectiveness endpoint:Clinical symptom assessment, endoscopic evaluation and clinical improvement. [Time frame: Week 4，Week 24]
- Radiation exposure [Time frame: Week 1]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06925607 · TH-SC01-RP-Ⅰ-05